Overview In this Senior Scientist role, you will serve as a safety pharmacology SME within the Safety Pharmacology Sciences team, guiding integrated strategies across discovery to regulatory submission. You will translate nonclinical data into clear recommendations for project teams and governance forums. You'll shape high-quality safety pharmacology plans and contribute to regulatory documents and external collaborations. This position offers the chance to advance innovative therapeutics while influencing safety science and development decisions.
Compensation / Benefits- comprehensive benefits package
- retirement and savings plan with generous contributions
- group medical, dental, and vision coverage
- life and disability insurance
- flexible spending accounts
- annual bonus and stock-based incentives
Responsibilities- Act as Safety Pharmacology subject matter expert on cross-functional teams, defining fit-for-purpose strategies across discovery, lead optimization, and development stages
- Design and oversee GLP and non-GLP safety pharmacology studies, ensuring rigor, feasibility, compliance, and timely delivery
- Evaluate and integrate data from cardiovascular, respiratory, CNS, ECG, hemodynamic, telemetry endpoints for relevance and regulatory impact
- Integrate safety pharmacology findings with toxicology, pharmacology, translational biology, DMPK, clinical, and regulatory information
- Contribute to governance discussions, regulatory strategy meetings, and milestone decisions
- Contribute to safety pharmacology sections of regulatory documents (IND-enabling summaries, Investigator's Brochures, briefing documents, responses)
Key requirements- PhD in Pharmacology, Neuroscience, Physiology, Biomedical Sciences, or related field (preferred)
- Experience supporting discovery and development as a safety pharmacology SME or toxicology representative
- Broad nonclinical safety pharmacology experience across cardiovascular, respiratory and CNS domains
- Experience as study director or SME for GLP and/or non-GLP safety pharmacology studies
- Authoring regulatory documents such as Investigator's Brochures, IND sections, briefing documents, or regulatory responses
- Strong cross-functional communication, problem-solving, and ability to manage multiple priorities in a matrixed environment
- Track record of scientific publications and participation in external forums or consortia
- Cross-functional collaboration
- Regulatory awareness
- Problem-solving
- Nonclinical safety pharmacology
- GLP and non-GLP study design and execution
- Cardiovascular, respiratory, CNS safety endpoints
