American College of Toxicology

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As a service to employers and members, ACT posts job opportunities in toxicology. The listing cost is $250 and the announcement remains for six months or until you ask us for removal. Please send employment opportunity announcements to ACT Headquarters.

Current Positions


Senior Scientist I/II/III, Toxicology Study Director

Company Name: AbbVie, Inc.
Location: Chicago (Lake County), IL

Posted: February 19, 2020

Job Description:

AbbVie (NYSE:ABBV) is a global, research-driven biopharmaceutical company committed to developing innovative advanced therapies for some of the world’s most complex and critical conditions. The company’s mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world. For more information about AbbVie, please visit us at Follow @abbvie on Twitter, Facebook or LinkedIn.

This position is in the Toxicology line function within the Preclinical Safety group and will report to the Director, Associate Director or a Sr. Group leader in Toxicology. This role designs, conducts and reports non-GLP and GLP general toxicology studies in support of drug submissions to regulatory agencies, and requires demonstrated effective written and communication skills.

Core Job Responsibilities:

  • The primary responsibility of this job is to function as GLP Study Director for AbbVie internally conducted toxicology studies (90 % of time) and external sponsor monitor for studies conducted at contract research organizations (< 10% of time).
  • As Study Director, the incumbent ensures the highest standards in quality and regulatory compliance are met in study conduct and reporting. Accountable for all aspects of GLP report authorship, including writing and reviewing toxicology study reports and preparing assigned components of filing documents that support submissions to global regulatory agencies for drugs in development.
  • Serve as scientific expert for studies, during audits and on project teams, committees and other assignments. Accurately identify key scientific findings and effectively communicate findings in reports, presentations, and meetings.
  • Demonstrate the ability to resolve key project study and assumptions by effectively utilizing available information and technical expertise.

Position Accountability/Scope:

  • Responsible for all aspects of GLP compliance within assigned studies and related departmental activities. Design, conduct and report toxicology studies appropriate to overall development plans and aligned with regulatory expectations.
  • Apply external scientific and regulatory information to development strategies and business practices.
  • The Toxicologist must design/critically evaluate and interpret experiments, record, tabulate and report results and significant issues. The Toxicologist must understand and follow established procedures and practices, ensure compliance with established procedures within the function, as well as possess a good understanding of appropriate FDA, ICH and OECD regulations and guidelines. The level of this opportunity will be commensurate with experience. The position could be a Sr. Scientist III, Toxicology depending on experience.

Basic Qualifications:

Responsible for GLP and non-GLP study conduct and project science within his/her area of expertise on one or more project teams. Demonstrates Toxicology expertise with agility, accountability and excellent communication skills. Demonstrates the ability to resolve study design and regulatory issues and key project hurdles and assumptions by effectively utilizing available information and technical expertise. Effective writer and communicator of research or other regulatory materials. Proactively seek relevant information in the literature and incorporate this into knowledge of Toxicology practices and overall program issues.

Skills/Experience Requirements:

  • BS and 7–12 years of experience; MS with 5–10 years of experience; PhD with 0–4 years of experience in Toxicology or closely related field, AND toxicology study director experience in pharmaceutical or contract research organization setting is REQUIRED.
  • Strong verbal and written communication skills to effectively communicate scientific data, issues and conclusions; work within small teams and in a matrix reporting structure environment; lead scientific issue identification and resolution.

Job level will be commensurate with experience.

Applying online:

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Associate Director, Toxicology

Company Name: Global Blood Therapeutics
Location: South San Francisco, CA

Posted: February 6, 2020

Position Summary:

Global Blood Therapeutics (GBT) is a biopharmaceutical company determined to discover, develop, and deliver innovative treatments that provide hope to underserved patient communities. The company has one FDA-approved therapy for sickle cell disease and one investigational therapy in development for the disease.

We are seeking for a toxicologist to interact with research and development teams to design critical pathways for nominating compounds as development candidates, design and conduct safety evaluation of development candidates to support clinical trials and registration, and to prepare nonclinical sections of regulatory submissions. This position is an individual contributor role and reports to the Head of Toxicology.

Essential Duties and Responsibilities:

  • Serves as Project Toxicologist on project teams in Research and Development
  • Collaborates with Research to develop critical pathways to select development candidates
  • Designs and manages studies for regulatory submissions that support clinical trials and product registration
  • Interacts with regulatory agencies on toxicity issues related to their projects
  • Maintains awareness of current and emerging standard practices and guidelines in the field


  • Academic training in toxicology, pathology or related discipline, preferably with advanced degree (Ph.D., D.V.M.) and board certification (DABT, DACVP)
  • At least 10 years of relevant experience in toxicology with a minimum of 7 years in pharmaceutical drug development
  • Development experience with small molecules (required) and biologics (desired)
  • Ability to work with interdisciplinary teams
  • Excellent communication skills
  • Excellent organizational and time management skills
  • Experience with managing studies conducted at CROs

Fit with GBT culture:

  • Ability to build strong relationships with co-workers of various backgrounds and expertise
  • Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor
  • Values-based leadership consistent with GBT's Core Values
  • Excitement about the vision and mission of GBT
  • Flexibility
  • Integrity

NOTE: This position summary is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.

Global Blood Therapeutics is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status, or any other characteristic protected by law.

If you are interested in applying, please visit

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Associate Director, Toxicology

Company Name: Scholar Rock
Location: Cambridge, MA

Posted: January 3, 2020

Scholar Rock is a clinical-stage biopharmaceutical company focused on creating a robust pipeline of product candidates with the potential to transform the lives of patients suffering from a wide range of serious diseases, including neuromuscular disorders, cancer, fibrosis and anemia. Our proprietary platform is built upon newly elucidated understanding of the molecular mechanisms of growth factor activation, which has led to the discovery and development of monoclonal antibodies that locally and selectively target these signaling proteins at the cellular level.

Our lead product candidate, SRK-015, is a highly specific inhibitor of myostatin activation and is currently being evaluated in a Phase 2 proof-of-concept trial for the treatment of patients with Type 2 and Type 3 Spinal Muscular Atrophy (SMA). SRK-015 has received Orphan Drug Designation in both the US and EU.

We are also advancing SRK-181, a highly specific inhibitor of TGFβ1 activation, into clinical development with plans to initiate a Phase 1 trial in patients with solid tumors in mid-2020. We believe SRK-181 has the potential to treat tumors resistant to checkpoint blockade therapy, such as anti-PD(L)1 antibodies.

Summary of Position:

Scholar Rock is seeking an outstanding individual with experience in nonclinical toxicology to join our research team in discovering and developing novel biologic therapies that target protein growth factors in the disease microenvironment. The successful candidate will be involved in assessing potential toxicities of novel antibodies that specifically modulate the function of disease-causing growth factors in such therapeutic areas as musculoskeletal diseases, fibrosis, cancer, hematology and autoimmunity.


  • Plan, execute and monitor toxicology studies for advancing candidates through lead optimization, candidate selection and into IND-enabling studies and beyond.
  • Directly interface with contract research organizations (CROs) to request quotes and derive cost estimates, provide input during protocol development and report generation/finalization and monitor study activities.
  • Review, summarize, interpret and report results of toxicology and safety pharmacology studies.
  • Provide strategic advice to project/program/product teams and senior management, including evaluation of conclusions and potential impact of study results on program and clinical/regulatory strategy.
  • Provide nonclinical study support to research, clinical and regulatory teams (including timing and reporting of all nonclinical studies and assuring compliance with all appropriate regulatory guidance).
  • Ability to both prepare and critically evaluate written scientific and regulatory documents for overall quality, clarity of presentation, and acceptability of scientific interpretation.
  • Capable of highly effective interactions with regulatory bodies in the process of product defense and support of global regulatory submissions.
  • Work closely with program leaders, clinical and regulatory teams to develop an overall toxicology development plan.


  • Ph.D. in Toxicology or relevant field; with a minimum of 5 years of experience in nonclinical development and proven track record of conducting regulatory toxicology studies (DABT certification preferred but not required).
  • Proficient knowledge and hands-on experience in all aspects of toxicology study conduct including general, developmental and reproductive toxicology, carcinogenicity, toxicokinetics, and safety pharmacology.
  • Experience in designing, conducting, monitoring, and interpreting discovery and exploratory toxicology studies to assist lead optimization and candidate selection efforts (experience with biologic drugs preferred).
  • Experienced in management of external CROs.
  • Ability to interpret and integrate complex data sets across multiple disciplines including pharmacology, DMPK, toxicology and pathology assessing the clinical relevance and impact.
  • Familiarity with GLP requirements and ICH guidelines.
  • Proficient in scientific documentation (IND, IBs. NDAs etc.) supporting submissions to regulatory agencies (FDA, EMA).
  • Experience representing function to global regulatory agencies in support of submissions.
  • Strong interpersonal skills to work effectively in a team setting/matrix-type organization.
  • Critical problem solving and organizational skills required.
  • Excellent oral and written communication capabilities, essential for successful contributions.

Apply Today

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Study Director—Toxicology

Company Name: Sinclair Research Center
Location: Location: Auxvasse, MO

Posted: December 3, 2019

Who We Are:
We provide the highest quality research due, in large part, to our employees. Our company is built on flexibility, outstanding service, and an amazing team. Sinclair Research offers specialty biomedical research services in a large range of species encompassing most categories of applied human and veterinary medicine. Our uniqueness includes our broad experience, the availability of multiple animal models, and one of the largest herds of miniature swine in the United States. We remain flexible and can tailor our efforts to almost any special procedure that is requested or designed. We strive to retain our customers through competitive cost, strong communication, timeliness, and response programs.

What We’re Looking For:
Sinclair Research is a growing, successful nonclinical CRO and is currently looking for an experienced toxicology Study Director to start immediately. As a Study Director you will be responsible for participating in the design of nonclinical safety studies as well as providing the scientific oversight of the study, including the interpretation of the data in the study report. These studies will involve the standard laboratory animal species (mice, rats, dogs, non-human primates, and swine) and typical test article types (small molecules, biopharmaceuticals, vaccines, etc.). It will also involve the ability to manage multisite studies, and maintaining the reporting timeline. You will be responsible for maintaining excellent Sponsor communications for your assigned studies. You may also assist in developing SOP’s, training materials, policies, and procedures regarding research conduct at Sinclair.

What You’ll Need:
Experience in the design, conduct, and interpretation of nonclinical toxicology studies along with excellent communication skills with Sponsors is a must. An advanced degree with at least 3 years’ experience is required. A Bachelor’s degree in a related field of study with at least five years of related experience, would also be considered. Experience in a CRO and toxicology are strongly preferred, and board certification is definitely a bonus. If you enjoy being part of a dynamic team, and share our passion for research, Sinclair is your company.

What You’ll Get in Return:
Do you like to have fun at work and be greeted in the halls? What about wearing scrubs every day, hanging out with your coworkers socially, and still getting to contribute to Scientific Research in a meaningful way? At Sinclair Research, we are team and our philosophy is to hire the best employees and provide them with opportunities to become exceptional!

Some of our benefits include health insurance, paid leave, paid Holidays, 401k matching, bi-weekly performance bonuses, annual reviews and year-end bonuses, and educational assistance. We also enjoy hanging out at our monthly employer sponsored lunches, monthly social events, annual picnic and holiday party, and even play kickball together during the summer. At Sinclair, we believe our passion drives your success and your success is our future.

Apply Today at Sinclair Careers.

Senior/Principal Scientist Development, Safety Assessment—Toxicology

Company Name: Genentech
Location: South San Francisco, CA

Posted: November 21, 2019

Job ID: 201906-118250

Job Function


Full time

Job Type

The Position:
The Department of Safety Assessment at Genentech provides scientific leadership and plays an active role in the process of drug development from the discovery period through marketed products. We are seeking a Senior/Principal Scientist in Toxicology to support drug development. This role will involve working in a collaborative team environment as part of the comprehensive safety assessment of Genentech therapeutics by providing toxicology representation to programs.

The successful candidate for Senior/Principal Scientist will provide scientific leadership and play an active role in the process of drug development from discovery through marketed products, with a strong emphasis on Genentech’s small molecule development project portfolios. Working in a collaborative team environment, the Senior/Principal Scientist leads the safety assessment of Genentech therapeutics by creating a best-evidence synthesis of existing knowledge and comprehensive investigations of toxicologic activity, strategic planning, and designing/implementing/supervising toxicology studies in support of program advancement.

Responsibilities include interdisciplinary project team membership, scientific leadership in the design and implementation of safety assessment strategies to support program advancement and decision-making, preparation and review of regulatory documentation, study reports and manuscripts, representation of Genentech in meetings with regulatory authorities, investigations into mechanisms of toxicity, proactive management of potential safety liabilities and communication of impact to teams and governance committees. Experience with cross-functional teams and capability to build productive cross-functional internal and external collaborations are desired.

Additional responsibilities include mentoring of toxicologists and as needed, team members, and lead or provide support to inter- and intra-departmental initiatives.


  • A PhD and post-doctorate or equivalent experience in toxicology or a relevant field along with a minimum of 8 years relevant experience in the pharmaceutical/biotechnology/CRO industry related to toxicology.
  • Extensive experience in small molecule drug development and interaction with global regulatory authorities are required.
  • Experience in developmental and reproductive toxicology is highly desirable.
  • Evidence of consistent and extensive record of impact internally and externally.
  • Board certification in toxicology is desirable.
  • The successful candidate must also demonstrate strong decision-making, complex problem solving, critical data analysis and interpretation, excellent written and verbal communication skills; and the ability to build productive cross-functional collaborations both within and external to Genentech

Who We Are
A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 40 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. Genentech has multiple therapies on the market for cancer & other serious illnesses. Please take this opportunity to learn about Genentech where we believe that our employees are our most important asset & are dedicated to remaining a great place to work.

The next step is yours. To apply today, visit our website.

Genentech is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status. For more information about equal employment opportunity, visit our Genentech Careers page.



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Associate Director of Toxicology

Company Name: Inotiv
Location: Maryland Heights, MO

Posted: November 18, 2019

Innotiv is a consultant-based, contract research lab that provides integrated services for discovery and preclinical drug development. Inotiv offers a unique alternative by integrating nonclinical disciplines in pharmacology, drug metabolism and pharmacokinetics, toxicology, and pathology in order to provide robust nonclinical evaluations of drug efficacy, safety, systemic exposure, and metabolism.

We are currently looking for a Senior/Principal Pathologist experienced with toxicology and drug development and with a passion for science and quality. Pathologists at Inotiv serve as technical experts and consultants in pathology and related fields. We work in a collaborative environment on projects throughout the discovery and development continuum. The ideal candidate will have a broad knowledge of toxicological pathology across multiple species as well as an in depth knowledge in a specialty area or organ system.

Key Responsibilities:

  • Interpret and report pathology findings in exploratory and regulatory studies including correlating microscopic findings to macroscopic observations, organ weight changes, and clinical pathology data
  • Conduct pathology peer reviews
  • Evaluate efficacy studies or animal models of disease
  • Maintain a current knowledge of pathology literature, best practices, and industry directions

Additional Responsibilities may include:

  • Providing pathology expertise for regulatory submissions and regulatory responses
  • Mentoring and providing senior-level guidance to less experienced pathologists
  • Consulting in toxicology and/or pathology
  • Demonstrating scientific leadership through participation in professional organizations, presentations, and publications


  • DVM and Diplomate of ACVP (anatomic pathology) or equivalent qualification
  • Industrial experience (3+ years)
  • Experience interpreting and reporting pathology findings for regulated (GLP) studies, preferably in a pharmaceutical or biotechnology company or a CRO conducting studies for pharmaceutical or biotechnology companies
  • Strong, effective written and oral communication skills including the ability to organize and clearly present complex data and concepts
  • Ability to work in a fast-paced environment, manage multiple projects, demonstrate consistent productivity, and meet project timelines
  • Ability to work independently and collaboratively
  • Remote location (work from home office) is possible

For more information please contact Dr. Stewart Jacobson, Vice President of Pathology Services at or visit the link to apply online.

Inotiv offers a competitive compensation and benefits package including health and dental insurance, a 401(k) plan, disability insurance, and life insurance.

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Senior Study Director/Toxicologist

Company Name: Inotiv
Location: Evansville, IN

Posted: November 18, 2019

Consider joining Inotiv as a Senior Study Director/Toxicologist in our Evansville, Indiana location. Our team is known for our scientific expertise, responsiveness to clients, exemplary regulatory record, and helping our clients meet key milestones on time. We foster an energetic, fast-paced environment and pride ourselves on the professionalism, motivation, flexibility and dedication of our team in supporting research that makes a real impact on people’s lives. We want your career with us to be enjoyable and rewarding, so if this sounds like the opportunity for you, come join us!

The Senior Study Director/Toxicologist will be responsible for the overall conduct of non-clinical in vivo studies. How you will contribute to make difference:

  • Maintaining and completing multiple projects simultaneously
  • Developing Protocols
  • Communicating with staff, management, and clients
  • Analysis, interpretation, and reporting of data from non-clinical studies 
  • Direct and/or supervise the work of technical staff in accordance with the GLP’s and SOP’s
  • Maintain knowledge of FDA and other regulatory guidelines 
  • Proactive recognition and resolution of any issues affecting the conduct of non-clinical studies   
  • Perform other duties as directed by the Director of Toxicology to meet our client needs

Experience, Education, Knowledge and Skills:

Qualifications include a PhD and/or DVM (DABT preferred) with at least 2 years of preclinical toxicology experience directing non-clinical in vivo studies at a CRO or pharmaceutical company. Experience may be substituted for education.   

Essential skills include: leadership; excellent communication including fluent command of the English language, writing and speaking; good organizational skills; knowledge and experience with Good Laboratory Practices; experience using computer applications; and data analysis skills are mandatory.
Please click here to apply or contact us directly at

Inotiv offers a competitive compensation and benefits package including health and dental insurance, a 401(k) plan, disability insurance, and life insurance.

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Senior Research Scientist

Company Name: Charles River
Location: Senneville, Montreal, Canada

Posted: November 16, 2019

For 70 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your background is in life sciences, finance, IT, sales or another area, your skills will play an important role in the work we perform. In return we will help you build a career that you can feel passionate about.
We are seeking a Senior Research Scientist for our toxicology department located in Senneville (Montreal)

The following are responsibilities related to the Senior Research Scientist position: 

  • Design, write, review and edit as necessary, study plans, amendments and study schedules that define and plan all activities with safety assessments (studies)
  • Oversee and co-ordinate all aspect of study procedures and ensure that projects are performed according to SOP and GLP
  • Prepare as necessary draft or final reports that document all study related procedures and results 
  • The scientist must ensure that a safe working environment is maintained by all project related staff through the observance of safety procedures, the use of protective clothing or equipment and by the distribution of relevant safety information. 

We are seeking a candidate who: 

  • Possess Ph.D, D.V.M, M.Sc., or B.Sc. in Toxicology or related biological discipline
  • Possess at least five years of experience in conducting toxicological research and/or a strong background in the area of specialization
  • Is organized, responsible and dynamic
  • Is able to resolve problems
  • Possess excellent communication, interpersonal and teamwork abilities

About Safety Assessment
Charles River is committed to helping our partners expedite their preclinical drug development with exceptional safety assessment services, state-of-the-art facilities and expert regulatory guidance. From individual specialty toxicology and IND enabling studies to tailored packages and total laboratory support, our deeply experienced team can design and execute programs that anticipate challenges and avoid roadblocks for a smooth, efficient journey to market. Each year approximately 120 investigational new drug (IND) programs are conducted in our Safety Assessment facilities.


  • PhD degree with equivalent, relevant experience required
  • 15+ years of industry experience in Regulatory Affairs and Toxicology for biologics products in product development and post licensure environments
  • Knowledge of global regulations/guidances and thorough knowledge of biological (large molecule) drug development process
  • Experience with international regulatory submissions preferred
  • Strong, hands-on people leadership experience and ability to guide and develop a team

About Charles River
Charles River is an early-stage contract research organization (CRO). We have built upon our foundation of laboratory animal medicine and science to develop a diverse portfolio of discovery and safety assessment services, both Good Laboratory Practice (GLP) and non-GLP, to support clients from target identification through preclinical development. Charles River also provides a suite of products and services to support our clients’ clinical laboratory testing needs and manufacturing activities. Utilizing this broad portfolio of products and services enables our clients to create a more flexible drug development model, which reduces their costs, enhances their productivity and effectiveness to increase speed to market.

With over 11,000 employees within 70 facilities in 18 countries around the globe, we are strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving our client’s unique challenges.  Our client base includes global pharmaceutical companies, biotechnology companies, government agencies and hospitals and academic institutions around the world. And in 2016, revenue increased by 23.3% to $1.68 billion from $1.36 billion in 2015.

At Charles River, we are passionate about our role in improving the quality of people’s lives. Our mission, our excellent science and our strong sense of purpose guide us in all that we do, and we approach each day with the knowledge that our work helps to improve the health and well-being of many across the globe. We have proudly supported the development of ~70% of the drugs approved by the FDA in 2016.

For more information, please visit

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VP of Preclinical Development

Company Name: Xencor Inc.
Location: Monrovia, CA

Posted: November 14, 2019

Xencor Inc. is an innovative biotechnology company headquartered in the Los Angeles area (Monrovia, CA) with a strong focus on bispecific antibodies and Fc engineering. We have an expanding clinical pipeline of promising therapeutic candidates and an immediate requirement for a Head of Preclinical Development. We use our pioneering XmAb® technology to develop better biotherapeutics—antibodies that target new biological mechanisms and are more potent, safer and longer lasting—to improve patient outcomes and quality of life. In addition to generating a pipeline of novel drug candidates, with twelve in clinical testing by Xencor or our partners, our XmAb® technology has been validated through our collaborative agreements with leading biopharmaceutical companies.

We seek a VP of Preclinical Development to lead scientific and managerial oversight of safety/toxicology, pre-clinical development, primate studies (non-GLP and GLP), and bioanalytical activities to support IND filings and ultimately BLA filings. This role will report to the CSO and mentor and guide staff to optimize the correct balance of science, global health authority expectations, and discovery-stage program derisking. Determine and mitigate organizational gaps and development of internal capabilities and outsourcing strategies to meet or exceed global health authorities' requirements and portfolio needs. Identify labor sources as necessary, for scientific and regulatory needs and development of a vertically integrated organization.

Core Responsibilities Include:

  • Collaborative oversite of preclinical safety assessment/toxicology, from preclinical development and IND-enabling activities through Phase III registrational studies and subsequent transition to commercialization
  • Leverage regulatory expertise and knowledge of regulatory requirements and regulations to strategically translate, plan and communicate requirements to ensure governmental approvals
  • Development and implementation of company policies and procedures for Preclinical development
  • Effective leadership and management of Safety Pharmacology and Bioanalytical groups ~ approximately 25 employees and growing


  • 15+ years’ experience in the areas of Toxicology and Regulatory Interaction
  • Direct experience with biologics drug development and toxicology/safety assessment at multiple stages of development (IND through BLA)
  • Hands-on participation in primate study design and implementation
  • Strong strategic and critical thinking, diplomacy, negotiation, and excellent oral and written communication skills
  • Proven ability to lead, coach and motivate employees
  • Experience with bispecific antibodies a plus


  • PhD degree with equivalent, relevant experience required
  • 15+ years of industry experience in Regulatory Affairs and Toxicology for biologics products in product development and post licensure environments
  • Knowledge of global regulations/guidances and thorough knowledge of biological (large molecule) drug development process
  • Experience with international regulatory submissions preferred
  • Strong, hands-on people leadership experience and ability to guide and develop a team

We strive to create an environment that will challenge, motivate, and reward our employees for meeting the changing demands of creating breakthrough therapeutics. Xencor has a highly collaborative structure that integrates co-workers with different skill sets into teams for product and technology development. With an emphasis on attaining the best and most highly qualified candidates in their respective fields, we offer a competitive salary & benefits package.

Please submit a cover letter & resume to

For further information about Xencor, please visit our website at

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Senior Principal Scientist – Preclinical Safety

Company Name: Merck Research Laboratories
Location: South San Francisco, CA

Posted: November 13, 2019

Job Description:
We are a global biopharmaceutical leader with a diverse portfolio of prescription medicines, oncology, vaccines and animal health products. We are driven by our purpose to develop and deliver innovative products that save and improve lives. With 69,000 employees operating in more than 140 countries, we offer state of the art laboratories, plants and offices that are designed to Inspire our employees as we learn, develop and grow in our careers. We are proud of our 125 years of service to humanity and continue to be one of the world’s biggest investors in Research & Development.

We are seeking an experienced Discovery Program Leader (DPL) to represent Safety Assessment & Laboratory Animal Resources (SALAR) on discovery research teams and represent SALAR in scientific and strategic review meetings with site and disease area management. The senior DPL is embedded with discovery teams and acts as a member of disease-area oversight committees and serves as the liaison back to the SALAR Preclinical Development organization located at our West Point, PA site. Thus, this position requires exceptional leadership, collaboration, and independence and a passion to work collaboratively across functions and sites to discover novel medicines that improve the lives of patients. The senior DPL is responsible for defining and overseeing the SALAR strategy for small molecule, peptide and biologics programs from Target Identification through to the approval of First-In-Human enabling GLP toxicity studies. They are responsible for 1) providing risk assessments for targets, 2) de-risking strategies for programs as members of discovery teams and 3) instructing SALAR staff at other sites to execute on the appropriate studies to support selection of therapeutic targets and the identification and development of new drug candidates with the highest probability of success for the intended indication. The DPL may also serve on development teams with responsibility for defining the GLP toxicology study strategy and execution, and for the non-clinical safety sections of regulatory documents that support clinical trials and worldwide marketing authorization.

In this role you will:

  • Represent SALAR on discovery teams and participate in therapeutic area discovery governance committee reviews.
  • Promote and facilitate creative thinking from target identification/validation through lead optimization towards advancing programs primarily in the Cardio-renal and Metabolic Disease Area but also Ophthalmic and Oncology Disease Areas.
  • Be a “drug creator” and promoter of innovative thinking by influencing both cross-site disease area aligned groups as well as functional area disciplines.
  • Be responsible for contributing to disease area strategy in collaboration with senior management and play a lead scientist role on Scientific Review committees.
  • The individual may also lead early development teams, informing on preclinical studies to support product development.
  • Identify and assess potential risks associated with therapeutic targets or development candidates using available literature, internal data, and external information.

Education Minimum Requirement:

  • PhD in relevant field, DVM, or MD degree is required.

Required Experience and Skills:

  • Minimum 10+ years of demonstrated pharmaceutical industry experience as a non-clinical safety scientist (e.g. Toxicology, Pathology etc.) and/or as non-clinical safety assessment representative to a cross-functional development and/or discovery teams.
  • Demonstrated ability to successfully navigate cross-functional lines and drive team decision making in a matrix organizational structure.
  • Highly dedicated, motivated, resilient and flexible; capable of creative problem solving and delivering on goals and objectives in a timely fashion in a scientific business model setting.
  • Excellent communicator who know when and how to speak up and appropriately raise issues to appropriated stakeholders and to management; keeps both team members, colleagues and management full apprise of project/initiative status and issues.

Preferred Experience and Skills:

  • Background and experience in immunology and immuno-oncolgy is preferred.

Apply online here:

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Lead Scientist, Preclinical PK/PD/Toxicology

Company Name: Xencor
Location: Monrovia, CA

Posted: November 13, 2019

Xencor is an innovative, clinical-stage biotechnology company located in the Los Angeles area (near Pasadena) and in San Diego. We use our pioneering XmAb® technology to discover and develop better biotherapeutics—antibodies and other proteins with improved function—with the goal of improving patient outcomes and quality of life.

We are seeking an in vivo Pharmacokinetics, Pharmacodynamics, Toxicology (PK/PD/Tox) scientist to design and execute Preclinical drug development studies evaluating and informing lead clinical candidate selection for engineered antibody therapeutics focused primarily, but not exclusively, on immuno-oncology. This is a Project Team Representative role that liaises with Xencor discovery and development project teams to design, analyze, and interpret in vivo studies performed at contract laboratories. The role does not include research pharmacology or animal models of disease. Grade level to be commensurate with experience and internal calibration.

This position reports to the Senior Director, Preclinical.

Some responsibilities include:

  • Interacts with other functional area experts in a project team environment to recommend the best course of preclinical development for a given program and defend those recommendations to executive management.
  • Designs appropriate PK/PD and toxicology studies to support large molecule drug development
  • In partnership with a study monitor, provides scientific leadership, oversight, and approval of studies implemented at contract laboratories
  • Applies and/or procures appropriate platforms and strategies such as physiologically-based pharmacokinetic (PBPK) modeling and simulation, Non-Compartmental and Compartmental PK simulation
  • Analyzes and interprets results and makes recommendations to teams and senior management
  • Prepare study reports and appropriate sections of the common technical documents for regulatory submission and queries on development candidates. Potentially interacts with health authorities
  • Maintain current knowledge of the field and area(s) of scientific expertise and development


  • DVM or PhD in Pharmacokinetics, Toxicology, or related science with a minimum of 3 years’ experience in large molecule/biologics drug development
  • Exceptional non-PhDs with demonstrated capabilities and/or significant experience may also be considered
  • Certification in Toxicology (DABT) is desired
  • Experience sourcing and/or monitoring non-human primate preclinical projects at a contract laboratory
  • Knowledge and experience in Good Laboratory Practices (GLPs)
  • High functionality in MS Office (Word, Excel, Outlook, PowerPoint) and data analysis and graphing software (eg, WinNonLin, GraphPad Prism, SpotFire, JMP)
  • Exceptional verbal and written communication skills; ability to communicate clearly and effectively with scientific colleagues and senior management
  • Must be able to demonstrate sound theoretical and experimental background in biology coupled with technical proficiency, scientific creativity, collaboration with others and independent thought
  • Excellent organizational, documentation, negotiation and interpersonal skills; adaptive learning and critical thinking.
  • Thrives in an entrepreneurial environment with initiative and flexibility in delivering independent and matrixed team contributions
  • Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Apply online here:

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Laboratory Operations Manager

Company Name: Covance, Inc.
Location: Madison, WI

Posted: November 12, 2019

Covance’s work in developing new pharmaceutical solutions has an incredible impact on millions of lives worldwide. Be a part of this life-saving work.

We have a Laboratory Operations Manager open in our Immunology & Immunotoxicology (I&I) area at our site in Madison, WI. This role provides provide support to Clinical, Safety Assessment (SA) and standalone studies over a wide range of Immunology and Immunotoxicology platforms, supporting enhanced solutions-based approach to Clients requests.

What we’re looking for in you:

  • 5 Years of experience in the job discipline.
  • Preferably experience in the supervision of operational/scientific teams.
  • Prior experience in Immunology / Immunotoxicology procedures, with knowledge of method development, and validation required.
  • Knowledge of GLPs and regulatory agency guidelines.
  • Strong customer service skills.
  • Aptitude for teambuilding, leading teams and developing people.
  • Knowledge in planning, negotiation, and process innovation.
  • Demonstrated ability to interact effectively with all staff and management levels.
  • Demonstrated problem solving and decision making skills.
  • Strong English writing and communication skills.
  • Advanced knowledge of computers and programs (e.g., word processing and spreadsheet applications).
  • Demonstrated ability to interact effectively with all staff and management levels.
  • Skilled in performing presentations.

If interested please apply online to:

There is no better time to join us!

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Senior Study Director

Company Name: Covance, Inc.
Location: Madison, WI

Posted: November 12, 2019

We have a great opportunity for a Senior Study Director specializing in Toxicology, Biologics, or Ophthalmology to join the Study Direction team at our Madison, WI site. Covance’s work in developing new pharmaceutical solutions has an incredible impact on millions of lives worldwide. Be a part of this life-saving work.

In this role, the Senior Study Director will:

  • Serves as the scientific specialist for a toxicology specialty program and serves as a Study Director for studies, as described in GLPs. The Study Director has overall responsibility for the technical conduct of a study, as well as for the interpretation, analysis, documentation, and reporting of results
  • Assists or may plan, design, and/or lead a team to conduct complex studies to generate high quality scientific results on behalf of Covance clients and play a key role in developing new strategies, techniques, and instrumentation for new ventures and critical issues in the area of specialty

What we’re looking for in you:

  • Has a PhD, DVM, or equivalent degree
  • 5-7 years’ experience in Toxicology
  • Maintains current regulatory awareness (domestic and foreign)
  • Is skilled in performing scientific presentations and preparing scientific publications
  • Is recognized by research peers as an expert in a selected technical field
  • In addition, DABT certification is desirable

Please apply online to:

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Study Director

Company Name: Covance, Inc.
Location: Somerset, NJ

Posted: November 12, 2019

Are you passionate about advancing your career while making a difference in patients’ lives?

Are you looking for an exciting career with room for growth within a supportive team?

If you answered yes to these, we’d like you to consider joining Covance as a Study Director at our Somerset, NJ site! We’re looking for someone with the drive to take on the responsibilities of planning, designing, and leading a team in the execution of studies that generate high quality scientific results in support of the development of life-saving medications.

In this role, you will:

  • Develop protocols and ensure that said protocols, including any changes, are approved and in compliance with appropriate standard operating procedures (SOPs), Good Laboratory Practices (GLPs), and regulatory agency guidelines
  • Monitor the progress and status of assigned studies, ensuring that all experimental data are accurately recorded and verified
  • Direct the preparation of reports, while ensuring compliance with protocol and regulatory requirements, and submit reports to clients
  • Practice project management skills
  • Interface with sponsors developing cutting edge medications
  • Partner with, and learn from, supportive colleagues and industry leaders

Working and thriving at Covance:

At Covance, you’ll work in a fast-paced environment and will continue to grow thanks to our learning-based culture. Your background will be put to work as you help in the advancement of healthcare and contribute to the world's largest and most comprehensive drug development services companies.

What we’re looking for:

To qualify for this role, we’d like you to have:

  • PhD in toxicology or related field preferred, BSc or MSc or equivalent degree in toxicology or related field
  • Skills in performing scientific presentations and preparing scientific publications
  • A focus on customer service
  • Project management experience

Get to know us:

Beyond excellent compensation and benefits as a Study Director, joining Covance opens the door to many career opportunities because you’ll be working for a company that truly invests in you!

Please apply online to:

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Study Director

Company Name: Covance, Inc.
Location: Madison, WI

Posted: November 12, 2019

Covance’s work in developing new pharmaceutical solutions has an incredible impact on millions of lives worldwide. Be a part of this life-saving work.

We have a Study Director position open in our Immunology & Immunotoxicology (I&I) area at our site in Madison, WI. This role serves as a Study Director, Principal Investigator or Contributing Scientist for immunotoxicology studies, as described in the GLPs. Learns overall responsibility for the technical conduct of a study as well as for the analysis and interpretation of data, documentation, and reporting of results.

What we’re looking for in you:

  • PhD preferred, or equivalent degree in immunology, immunotoxicology or related field, or Master’s or Bachelor’s degree in related discipline plus 8-10 years of experience. Experience may be substituted for education
  • Prior experience in Immunology / Immunotoxicology procedures, method development, and validation preferred.
  • Flow Cytometry, ELISA, ImmunoAssay/Ligand Binding Assay/Biomarker experience Knowledge of drug development, CRO industry, and data interpretation/report writing
  • Customer service skills
  • Ability to interact effectively with all staff and management levels
  • Problem solving and decision-making skills
  • Strong English writing and communication skills
  • Knowledge of computers and programs (e.g., word processing and spreadsheet applications)

There is no better time to join us!

Please apply online to:

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Director, Toxicology

Company Name: Turning Point Therapeutics
Location: San Diego, CA

Posted: November 12, 2019

Turning Point Therapeutics is a clinical-stage biopharmaceutical company designing and developing novel small molecule, targeted oncology therapies to address key limitations of existing therapies and improve the lives of patients.

We are seeking a scientific leader to oversee nonclinical safety pharmacology and toxicology efforts of our company as Director of Toxicology. The role will be involved in the design, execution, analysis, interpretation and communication of nonclinical safety studies of small molecule and their associated delivery system to provide nonclinical safety profile and risk assessment to support drug development. This position requires strong intellectual leadership, working at the interface of discovery and development teams and will serve as the nonclinical subject matter expert. The incumbent will design, conduct, and interpret nonclinical toxicology and investigational safety studies; will advise management on the toxicological aspects of the project and will effectively communicate with worldwide regulatory agencies to bring our drugs to patients as quickly as possible. This is an ideal position for an independent individual with a strong background in discovery and preclinical toxicology and safety pharmacology who enjoys working in a team-oriented and highly cross-disciplinary environment.


  • Support our discovery group in the safety testing of lead compounds, including introduction of new testing paradigms
  • Design, supervise, interpret, and report in vitro and in vivo nonclinical toxicology IND-, late-stage clinical trial- and NDA- enabling studies.
  • Participate in the management of CROs/academic sites in the conduct of in vitro/in vivo safety studies and near-term potential to set up in-house toxicology capabilities
  • Participate in the preparation of preclinical dossiers for worldwide regulatory submissions, including authoring the nonclinical safety components of regulatory dossiers (e.g. IB, INDs, NDAs) and communications as well as responses to inquiries from regulatory agencies.
  • Work closely with internal functional groups such as Pharmacology, ADME-PK, BA, CMC, Regulatory Affairs, Clinical Development, and Project Management, and actively participate in team strategy discussions for drug development programs.
  • Lead teams of preclinical experts in respective projects.
  • Responsible for providing non-clinical safety support to in-licensing review teams
  • Participate in the preparation of abstracts and manuscripts for publication


  • DVM or PhD in pharmacology, toxicology, or related scientific discipline.
  • Board certification (DABT) is a plus.
  • 10+ years of relevant industry experience in toxicology, supporting drug discovery, research and development.
  • Proficient knowledge of general toxicology and related disciplines, with evidence of drug development experience.
  • Experience with in vitro assays utilized in discovery and toxicological assessment.
  • Familiar with regulatory toxicology guidelines, requirements and standards (GLP, OECD, ICH, CTD, etc.) and able develop nonclinical strategies that support clinical development.
  • Experience in authoring nonclinical components of regulatory dossiers.
  • Independent self-starter with the ability to work in a matrixed, cross-functional, team-based drug discovery/development environment.
  • Excellent verbal and written communication skills; ability to communicate clearly and effectively with scientific colleagues and senior management.

EEO & Employment Eligibility

TP Therapeutics is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. TP Therapeutics also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. TP Therapeutics is an E-Verify employer.

Apply Online:

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Senior Scientist, Toxicologist – Product Integrity (Stewardship)

Company Name: Reynolds American Inc.
Location: Winston Salem, NC

Posted: November 12, 2019

Employment Type (Full or Part-time, Temporary) – Full Time

Required Skills

  • Mastery of literary & laboratory research skills to use web search and scientific databases for bibliographic research and scientific monitoring.
  • Strong scientific and technical writing skills.
  • Proficiency in Microsoft Office software; strong computer experience is essential.
  • Excellent project management and teamwork skills.
  • Excellent interpersonal, written/oral communication skills.

Preferred Skills

  • Experience applying quantitative risk assessment (QRA) approaches and the preparation of human health risk assessments.
  • Experience with the preparation of documents in support of regulatory submissions.
  • Experience with critical evaluation of in vivo and in vitro toxicological studies.
  • Experience organizing and working with large datasets of information.
  • Proficiency with EndNote or equivalent.

Required Skills

RAI Services Company (RAIS) is seeking a toxicologist to support the development of new products consistent with RAIS' Growth, Innovation and Harm Reduction Platforms, and provide support for efforts such as regulatory submissions. The incumbent will be required to provide stewardship and regulatory support for consumer products, critically assess a broad range of toxicological information, evaluate chemical and toxicological data, develop technical documents on a variety of scientific and risk assessment topics, and assist with the preparation and/or review of information supporting regulatory submissions. The individual will be required to interact cross-functionally, across the enterprise, and globally, as well as manage multiple projects to ensure project timelines are met.

Key Responsibilities Include:

  • Provide stewardship support across products, materials, ingredients, technologies, manufacturing processes, etc., for RAI Operating Companies
  • Develop technical documents on various scientific, risk assessment, and regulatory topics, including toxicological data summaries.
  • Assist with the design, management, and interpretation of chemical and toxicological studies at contract research organizations to support product development and regulatory submissions.
  • Lead and/or assist with the preparation of documents in support of regulatory submissions.

For more details and to apply:

Talent Acquisition Contact:

Mike Parks, | 336-741-0695 (Office) | 919-272-0447 (Mobile)

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Senior Director/Executive Director, Pharmacology/Toxicology

Company Name: Audentes Therapeutics, Inc.

Posted: November 8, 2019

About Audentes Therapeutics
Audentes Therapeutics is a leading AAV-based genetic medicines company focused on developing and commercializing innovative products for serious rare neuromuscular diseases. We are leveraging our AAV gene therapy technology platform and proprietary manufacturing expertise to develop programs across three modalities: gene replacement, vectorized exon skipping, and vectorized RNA knockdown. Our product candidates are showing promising therapeutic profiles in clinical and preclinical studies across a range of neuromuscular diseases. Audentes is a focused, experienced and passionate team driven to improve the lives of patients.

Audentes leverages strong, global relationships with the patient, research, and medical communities, and we take pride in carefully selecting our colleagues. Listed below is a current opening for a smart, driven, experienced, and just plain nice individual who wants to join us on our journey.

The Role
Reporting to the SVP, Translational Science the Senior Director/Executive Director, Pharmacology /Toxicology will lead the Pharmacology Toxicology function within Translational Science. The role will be responsible for coordinating, analyzing and reporting on animal pharmacology, pharmacokinetic, and toxicology studies aimed at proving safety and efficacy of candidate products for gene therapy of neuromuscular diseases. Additionally, the role includes responsibility for study data management/ cross-department presentation of relevant data, coordinating animal studies and corresponding report writing.


  • Active member of the translational leadership team with shared responsibility for developing and implementing the Company’s translational research pipeline.
  • Lead a team of scientists in Pharmacology/Toxicology to advance Company’s gene therapy pipeline.
  • Develop overall toxicology strategy for assigned programs.
  • Ensure management and execution of nonclinical studies within budget and established timelines.
  • Design nonclinical studies and ensure that they are conducted in compliance with relevant SOPs, regulatory requirements, Good Laboratory Practices and the highest quality standards.
  • Evaluate data quality and study progress, inform management of potential issues, develop solutions and work with the team on corrective action plans.
  • Oversee selection and management of nonclinical vendors. Negotiate contracts and budgets with sites and vendors.
  • Ensure maintenance of nonclinical documents.
  • Liaise with other departments to coordinate and plan for the availability of nonclinical supplies necessary to meet study requirements.
  • Represent Pharmacology Toxicology on cross-functional project teams for strategic planning, risk/benefit assessments and achievement of company, project and team goals.
  • Develop and continually improve departmental infrastructure including development of SOPs.
  • Travel up to an average of 20% to partners and vendors.


Required Qualifications

  • 15+ years in the biotech/pharmaceutical industry with BS in Pharmacology/Science or 12+ years with MS in Pharmacology/Science in or 10+ years with PhD in Pharmacology/Science.
  • Exceptional leadership skills; 5+ years’ experience managing Scientists and Research Associates in industry.
  • Demonstrated experience coordinating conduct of in vivo studies.
  • Experience in pharmacokinetics, toxicology and animal pharmacology/monitoring animal studies.
  • Successful experience writing/reviewing regulatory sections of IND.
  • In depth experience managing CROs to achieve nonclinical milestones on time and within budget.
  • Comprehensive knowledge of the drug development process including cross functional integration from POC through Phase I.
  • A transparent, flexible, can-do approach to address issues innovatively and proactively to promote teamwork and a pleasant work environment.
  • Outstanding influencing, oral and written communication skills.
  • Successful history working with all levels in dynamic, hands-on environment.
  • Models Core Values: Be Bold, Care Deeply, #GetStuffDone – is experienced as someone who exemplifies the culture we want to create; operates with transparency; is trusted.


Preferred Qualifications

  • Experience with rare diseases, neuromuscular diseases and/or gene therapy products.
  • Experience in a small company and high growth, fast-paced environment.


Visit our website at

All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability. 

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Senior Scientist (Toxicologist)

Company Name: Mylan, Inc.
Location: Morgantown, WV

Posted: November 8, 2019

For Us, It’s A Mission
At Mylan, we mean it when we say we work every day to provide access to high quality medicines to the world’s 7 billion people. If you are unconventional, relentless and passionate.  If you believe in doing what’s right, not what’s easy. If you are a doer and have a passion for serving others, we want to talk to you.

Make a Difference
At Mylan, each person has the ability to make a difference. From the providers who sell and market our products to the producers who develop and manufacture them and finally to our business partners who support the providers and producers, we all have a mission critical role. Here’s how this role will help:

  • Assess and resolve impurity, degradant and device-related qualification issues.
  • Designing, planning and overseeing the conduction of pharmacology, safety pharmacology and toxicology studies.
  • Assisting in the selection, auditing and approval of contract testing facilities used for such studies, ensuring data quality and integrity from monitored preclinical sites.
  • Author and review research reports, protocols, guidelines and SOPs for the department.
  • Provide support in the research and construction of regulatory study documents, technical scientific analyses and positional papers (i.e., IND/NDA documents, Applications for Marketing Authorizations, etc.).
  • Represent the department and Mylan in meetings with global regulatory health authorities and attending internal meetings.


Make Our Values Your Values
Mylan hires only the best. People who thrive in a culture of innovation and empowerment. People who are active learners and have a positive attitude. People who are leaders and know that by working together we can run faster, reach higher and achieve more. By doing so, we will continue to set new standards in health care. Here are the minimum qualifications for this position:

  • The prefered candidate will have a PhD with 2 years of experience in pharmaceutical laboratory or a minimum of 4 years with a Masters degree or 9 years with a Bachelor degree. However, combination of experience and/or education will be taken into consideration.
  • Must possess knowledge of the biological impact of drug materials in the human body and application of GLP and ISO regulations is required. Knowledge of applicable world health authorities’ regulations, standards and guidelines covering drug development is essential.
  • Must possess effective organizational, oral and written communication and computer skills. Must be able to interact with a diverse workgroup in a team-oriented environment with the ability to communicate performance expectations in a clear and concise manner.
  • Ability to read and interpret comprehensive and intricate research documents. Ability to write scientific reports and technical correspondence. Ability to work with executives and communicate abstract concepts. Ability to present to a high level of the organization and groups outside of the organization.
  • Ability to solve problems with complex variables through non-standardized solutions that require independent judgment and analysis. Ability to draw inferences and use deductive reasoning with no prescribed procedures to solve complex problems.


Why Mylan?
If you want to be part of a global health care company that is making a difference and changing lives, Mylan may be the place for you. With a workforce of more than 35,000 worldwide, we can make a difference. We encourage you to visit to learn more about our unconventional culture, our approach to doing business and how we plan to set new standards in health care.

Mylan offers competitive salary, excellent benefits and an environment conducive to professional growth and advancement. All qualified applicants will receive consideration for employment without regard to their disability or protected veteran status. Mylan is an Equal Opportunity Employer, Minorities/Female/Disabled/Veteran.

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Associate Director, Medicinal Safety

Company Name: Daiichi-Sankyo
Location: Basking Ridge, NJ

Quantitative Clinical Pharmacology (QCP)—Medicinal Safety
Reports to: Senior Director, Medicinal Safety

Posted: November 5, 2019

Job Summary

This position for Medicinal Safety (Toxicology) will lead nonclinical safety discussions (such as strategy for general toxicology studies, de-risking strategy and risk communication), as the MSRL Toxicology Representative, in the assigned Global Project Teams (GPTs). When assigned as Study Director, incumbent will be responsible for preclinical toxicology studies conducted at CROs in the West. Position will also contribute to the quality of nonclinical safety sections of regulatory documents to assure the integrity of such documents. Incumbent will construct and review nonclinical toxicology sections of regulatory documents including but not limited to investigational and new drug applications. Position will contribute to nonclinical safety studies’ protocol design, execution of toxicity studies’ conduct, safety data collection and interpretation, risk communication, and interact with regulatory authorities after consultation with supervisor. Additionally, incumbent will work effectively with global multi-disciplinary project teams while operating in collaboration with Global Medicinal Safety colleagues on emerging nonclinical safety issues and due diligence assignments as needed. Incumbent will also represent MSRL in interactions with Senior Management.


Serves as MSRL Toxicology Representative in Global Project Teams (GPTs), oversees nonclinical Study Director at CROs in the West, contributes to execution of toxicology studies’ protocol design in accordance to the ICH directives, and interpretation of such nonclinical safety data for use in global Regulatory Agencies’ applications. Proactive in nonclinical safety problem identification, risk communication, and contributes to resolutions.

Contributes to preparations and reviews of regulatory nonclinical safety data draft documents; engages in supervised interactions with regulatory authorities as needed especially in assigned drug development projects. Supports and contributes to selection of toxicology consultants/experts for newly emerging safety issues for on- and real-time resolution.

Day-to-day adherence to good working knowledge of non-clinical safety-related guidance, guidelines and regulations as required by regional Regulatory Agencies in ICH member regions and familiarity with the ICH processes for drug development. Supports and contributes to internal/external collaborations on drug development and safety biomarker development.

Supports effective collaboration with global multi-disciplinary team as nonclinical toxicology representative and DSI in-licensing effort and due diligence.


Education: PhD or DVM (Vet.) Board Certified Toxicologist preferred, but not required.

Experience: Minimum of 5+ years of drug development experience in the pharmaceutical industry as a practicing toxicologist. Wet lab or bench work capabilities will be considered as an asset. FDA regulatory experience is not required, but highly desired.

Competencies: Dynamic individual with good technical, writing and communication skills. Ability to influence others, analytical, and good interpersonal and team player skills.

For more information and to apply, visit our website:

Daiichi-Sankyo is an EEO/AA/Disability/Vets employer.

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Head of Toxicology

Company Name: Neurocrine Biosciences
Location: San Diego, CA

Posted: November 1, 2019

Who We Are:

At Neurocrine Biosciences - voted one of San Diego's top places to work in 2018 - we pride ourselves on having a strong, distinctive and positive culture based on our shared purpose and values. We know what it takes to be great, and we are as passionate about our people as we are about our purpose - to relieve patient suffering and enhance lives.

What We Do:

Neurocrine Biosciences is a biopharmaceutical company focused on developing treatments for neurological and endocrine related disorders.

About the Role:

The Head of Toxicology will be a key leader in the Preclinical Development group at Neurocrine Biosciences that oversees ADME, Toxicology and Clinical Pharmacology activities. This individual will be responsible for overseeing the Toxicology function at Neurocrine and the analysis, interpretation and reporting of Safety Pharmacology and Toxicology data for Neurocrine’s Discovery and Development programs. The position will liaise with Research and Development colleagues to develop overall Safety Pharmacology and Toxicology Development Strategies for subsequent ratification by project teams. The individual will also represent Preclinical Development on Discovery and Development teams and regularly interface with internal and external colleagues to ensure timely and accurate dissemination of Safety Pharmacology and Toxicology findings.

Your Contributions (include, but are not limited to):

  • The primary role is to lead the Toxicology group in the conduct, interpretation and reporting of Safety Pharmacology and Toxicology studies/data
  • Manage project assignments within the Toxicology function to ensure timely completion of priority activities
  • Critically evaluate toxicology results and provide strategic advice to project teams and senior management on the potential impact of toxicology results on Program and Clinical/Regulatory strategy
  • Oversee the preparation of Safety Pharmacology and Toxicology sections of regulatory documents (IND, NDA, briefing books, Investigator Brochures, etc.)
  • Represent Preclinical Development on discovery and development-stage program teams
  • Oversee the preparation of data summaries and presentations of results to peers, colleagues and Neurocrine Management
  • Prepare SOPs as needed to guide functional activities
  • Be knowledgeable with current regulatory guidances
  • Inspire, mentor and grow Neurocrine’s Toxicology team
  • Other tasks as assigned


  • Ph.D. in Toxicology, Pathology or closely related discipline or D.V.M. with at least 15 years of pharmaceutical/biotech experience
  • Knowledge/experience in toxicologic pathology is beneficial
  • Experience in managing clinical Contract Research Organizations
  • Experience with preparation of INDs, CTDs, NDAs, and MAAs
  • Proactive, innovative, with good problem-solving skills
  • Experience working in a cross functional team and matrix environment
  • Excellent written, presentation, and verbal communication skills

For more information and to apply, visit our website:

Neurocrine Biosciences is an EEO/AA/Disability/Vets employer.

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Principal Scientist, Toxicology

Company Name: Moderna
Location: Cambridge, MA
Reports to: Director, Toxicology

Posted: October 16, 2019

The Principal Scientist will lead all aspects of toxicology work for select nonclinical programs to enable drug candidates from research through development and IND enabling studies. The principal scientist will design, execute, and interpret nonclinical safety studies conducted in multiple species, and will be heavily involved in regulatory submissions and interactions with various health authorities as well as the internal clinical team. The successful candidate must have the ability to multitask and to function effectively in a fast-paced environment. Be capable of conducting work independently, but also capable of pulling in subject matter experts when necessary to lead the conversation. Will maintain extensive scientific awareness and presence in toxicology, publishes manuscripts and posters, presents at scientific conferences and other scientific forums. Engages with consultants and advisors in the field, as well as the scientific community at large.

Here’s What You’ll Do:

  • In conjunction with program teams and the nonclinical sciences team, develop toxicology strategies and provide expert support to research and development projects
  • Collaborate on the design of non-GLP investigative and pharmacology studies to support development compounds, as needed
  • Review, summarize and integrate complex data sets across multiple disciplines
  • Manage the preparation and presentation of nonclinical safety data for project teams, portfolio management, internal /external partners and/or scientific groups
  • Provide strategic advice to project teams and senior management including evaluation of conclusions and potential impact of toxicology results on program and clinical/regulatory strategy
  • Lead finalization of toxicology reports and manage the tabular presentation of data in accordance with CTD format
  • Support the preparation of national and international regulatory submissions and interactions with health authorities and be capable of effective communications with regulatory authorities
  • Interact cross functionally with Research, Regulatory, Clinical and Manufacturing
  • Work closely with clinical to ensure toxicology support for clinical trial designs
  • Mentor junior members of the team by providing scientific input and leading by example
  • The qualified candidate will serve as a resource for the department and project teams, proactively keeping colleagues/leadership updated with industry trends.

What You’ll Bring to the Table:

  • Doctorate degree & 5–10 years of scientific experience OR Master’s degree & 8–10 years of scientific experience OR Bachelor’s degree & 10–15 years of scientific experience in preclinical toxicology and drug development in the pharmaceutical/biotechnology sector
  • Familiarity with GLP regulations and ICH/FDA guidelines for the conduct of toxicology studies to support regulatory filings
  • Experience working with Contract Research Organizations
  • Ability to develop and deliver clear and concise presentations for both internal and external meetings
  • Outstanding written and verbal communication skills
  • Ability to multi-task and change quickly change priorities

Why Join Moderna?

At Moderna, we believe messenger RNA, or mRNA, is the “software of life.” Every cell in the body uses mRNA to provide real-time instructions to make the proteins necessary to drive all aspects of biology, including in human health and disease. Given its essential role, we believe mRNA could be used to create a new category of medicines with significant potential to improve the lives of patients.

Headquartered in Cambridge, Massachusetts, Moderna currently has strategic alliances for development programs with AstraZeneca, Plc. and Merck, Inc., as well as the Defense Advanced Research Projects Agency (DARPA), an agency of the U.S. Department of Defense; and the Biomedical Advanced Research and Development Authority (BARDA), a division of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS). Moderna has been ranked in the top ten of Science’s list of top biopharma industry employers for the past four years. To learn more, visit

For more information please email Angela Grady at

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Non-Clinical Reviewer

Company Name: US FDA, CDER, OND
Location: Silver Spring, MD

Posted: October 14, 2019

Job Description:

Are you making a difference contributing to the public health and well-being of millions of Americans? Would you like to? The physicians, scientists and other dedicated professionals at the U.S. Food & Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Office of New Drugs (OND) located in Silver Spring, MD, contribute to the public health of millions of Americans every day. We pride ourselves on our dedicated and skilled staff and are always looking for committed individuals to help us achieve our mission.

CDER is responsible for regulating prescription drugs, including new drugs, generic drugs, biological products and biosimilars as well as over-the-counter drugs. CDER’s drug regulatory responsibilities include premarket review of new drugs and generic drugs; maintenance of the OTC drug monograph system; monitoring of all marketed drug safety and promotional activities; review, monitoring and enforcement of drug quality during the entire drug life cycle; and ensuring drug products in the market comply with the law. OND’s public health mission is to protect and enhance the health of the public through the review and evaluation of scientific data submitted by pharmaceutical manufactures in support of New Drug and Investigational New Drug applications (NDA/IND), and to determine if candidate drugs are safe and effective. OND is seeking scientists to serve as nonclinical reviewer’s in various drug review divisions.

The nonclinical reviewer is responsible for reviewing and evaluating the results of nonclinical pharmacologic, toxicologic, and pharmacokinetic studies submitted in support of INDs, NDAs, and BLAs; these studies assess drug safety based on studies conducted by the drug developer. Review of the nonclinical pharmacologic and toxicologic data includes evaluation of the quality and adequacy of the various assessments and studies. These reviews serve as the basis for calculating initial safe starting doses in clinical trials, doses for longer duration clinical trials, and for product labeling (the package insert). Nonclinical reviewers prepare a comprehensive review of the data and submit recommendations and conclusions for consideration of the review team. As a nonclinical reviewer, you will have the opportunity to:

  • Advance the public health through new drug development;
  • Experience teaching and training opportunities;
  • Interact with pharmaceutical companies; and
  • Work with a wide range of scientific disciplines in a team-oriented atmosphere.

Salary & Benefits:

  • Civil service salary starting at the GS-13 level
  • Excellent federal government benefits package (health insurance, life insurance, retirement, etc.).
  • Relocation expenses and student loan repayment may be paid to eligible candidates.
  • Flexible and/or partial telework schedules available (after completion of initial training period).


Applicants must have a doctorate degree in pharmacology, toxicology, or a related field from an accredited university. Any applicants with ocular and/or ophthalmology-related experience should state it in their cover letter when submitting their application. Foreign graduates must have their transcripts and degrees evaluated by a credential evaluation service that is recognized by the National Association of Credential Evaluation Services (NACES) or the Association of International Credentials Evaluators (AICE). Candidates must be U.S. citizens. Permanent U.S. residents may apply for staff fellowship appointments.

To Apply:

Please send a current CV/resume and cover letter to for consideration. Please reference source code: #20-033EG in the subject line of the email.

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Vice President, Pharmacology & Toxicology

Company Name: AnaptysBio
Location: San Diego, CA

Posted: October 09, 2019

This position leads a team in executing early clinical drug development activities evaluating the pharmacology and toxicology of antibody therapeutics focused primarily, but not exclusively, on immune-inflammatory diseases. As a key member of the development team, this role liaises with Discovery Project Team Leaders. The VP, Pharmacology &Toxicologyserve as a Development project team leader, where appropriate, and work collaboratively with the executive management to develop of key program stratgies, and strengthen the capabilities of the company.

This postion reports to the Chief Medical Officer.

Primary Responsibilities

  • Crafts the pre-clinical and clinical pharmacological strategies, including dose escalation, contributing to stopping rules, and risk-benefit to ascertain that compounds are entered into man safely, efficiently and with scientific validity.
  • Oversees the development and validation of quantitative in vivo assays to enable pharmacological characterization of therapeutic antibodies
  • Establishes collaboration with CROs andor academic institutions to develop in vivo pharmacology models to permit progression into the clinic of therapeutic antibodies
  • Provides strategic and tactical direction to multiple project teams
  • Prepares study reports for regulatory submission on development candidates
  • Contributes to new project ideas and in vivo proof-of-concept studies to enable the initiation of new antibody projects
  • Leads the Development project team and oversee the transition from discovery to clinical development of new antibodies


Education & Experience

  • PhD in Pharmacology or related science with a minimum of 15 years’ experience in a drug-discovery setting of a biopharmaceutical company, accompanied by at least 5 years of proven leadership experience.
  • Extensive experience in developing quantitative in vivo pharmacodynamic assays and preclinical disease models to assess target engagement and efficacy in a range of inflammatory/autoimmune conditions
  • Proven track record of making major contributions to the discovery of one or more marketed or in-development medicines
  • Prior experience of working across diverse therapeutic areas is highly desirable.
  • Proven managerial competence with previous experience in directly managing teams


  • Direct experience and knowledge of all the requirements (pharmacokinetics, toxicology, formulation etc.) needed to progress to first-in-human studies and different stage of clincal development
  • Sound theoretical and experimental background in biology coupled with a solid foundation in quantitative pharmacology
  • Ability to perform randomized controlled clinical trial principles, methodology and procedures.
  • Skilled at statistical data collection, editing, validation and analysis techniques.

For more information and to apply, visit our website:

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