In this role in Drug Safety Research and Development (DSRD), the individual will serve as the Drug Safety Team Lead (DSTL) as the representative on multidisciplinary project teams developing biologics, gene therapies, vaccines, including RNA modalities, and/or small molecule drugs. The DSTL is responsible for developing and implementing the nonclinical safety strategy for projects from Idea to Loss of Exclusivity (LoE). The DSTL coordinates all activities supporting the nonclinical safety strategy to achieve project team objectives and goals, and support stage-gate transitions.
In this role, the individual would identify potential toxicities as well as create strategies to either mitigate or monitor these risks in the clinic. Within DSRD, the DSTL will work with various specialty lines (eg, immunotoxicology, pathology, investigative toxicology, general toxicology, etc...) to ensure that all supportive studies and potential safety risks are fully understood. The DSTL works closely with the Drug Safety Therapeutic Area Leader (TAL) to communicate project progress and achieve alignment on timelines, risk management, mitigation strategies, etc.
In addition, DSTLs serve as nonclinical safety Subject Matter Experts (SMEs) and may act as the Regulatory Toxicology Lead (RTL) to prepare the nonclinical content towards global regulatory submissions and regulatory queries. The DSTL will represent DSRD at project-related regulatory interactions, support in-licensing reviews, and may take on additional roles depending on their qualifications
Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.ROLE RESPONSIBILITIES
- Provide nonclinical scientific and regulatory strategy leadership and input on crossline matrixed project teams from pre-FIH through LoE.
- Represent DSRD at project-related regulatory interactions.
- Coach/mentor more junior colleagues to eventually take on this role independently.
- Participate in Due Diligence activities as needed.
- When acting as RTL, contribute to ensuring compliance of dossiers to global health authority standards and work closely with regulatory submission scientists and document specialists in the Portfolio and Regulatory Strategy line.
- The candidate may be involved in developing and implementing strategies to influence the internal and external (health authorities) nonclinical regulatory environment
- As the RTL, the candidate will be the lead author of all nonclinical toxicology components of any submission to global health authorities.
- Lead external industry consortium/scientific efforts to optimize nonclinical safety strategy and/or submission requirements.
- Advanced degree such as a PhD, MD, or DVM and expertise in Toxicology, Pathology or allied biological sciences
- Experience level should be a minimum of 10+ years in nonclinical aspects of pharmaceutical drug development, spanning early stage to post market scientific strategy and submissions.
- Expectations include a working knowledge of international regulatory guidelines and practices, demonstrated ability to develop strategies of high quality, appropriate decision-making regarding candidate development and regulatory submissions, ability to communicate verbally and in written context well across business lines, and effective leadership of teams of diverse expertise
- Specific working knowledge of nonclinical safety requirements across a broad range of therapeutic areas and modalities
- Hands on experience in design, conduct, and interpretation of nonclinical toxicology studies
- Demonstrated ability to author regulatory documents of high quality
Ability to formulate a concise summary of complex safety (Toxicology, Pathology, pharmacokinetics and biology) data from multiple sourcesNON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Relocation support available
Work Location Assignment:Flexible
Relocation assistance may be available based on business needs and/or eligibility.
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Research and Development