Pioneering Medicines: Senior Director, Head of Toxicology
Listed on 2026-07-03
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Business
Regulatory Compliance Specialist
Position Summary
The Senior Director, Head of Toxicology will lead and build the toxicology function within Pioneering Medicines, defining and executing nonclinical safety strategies across a diverse and rapidly evolving portfolio. This role provides scientific and strategic leadership across both investigative and regulatory toxicology, supporting a broad range of therapeutic modalities.
Working in a dynamic venture creation environment, you will collaborate closely with multidisciplinary teams to optimize candidate selection, guide preclinical development, and ensure regulatory readiness. This is a high-impact role requiring strong analytical thinking, scientific rigor, and clear communication, influencing programs from discovery through early clinical development.
Key Responsibilities- Lead, build, and scale the toxicology function, including internal team development and external partnerships
- Define fit-for-purpose operating models spanning investigative and regulatory toxicology
- Serve as the primary internal expert for nonclinical safety, ensuring quality, consistency, and scalability across the portfolio
- Define and drive toxicology strategies across multiple programs and modalities
- Translate findings into clear risk assessments, mitigation strategies, and IND/CTA-enabling plans
- Enable transparent, data-driven decision-making by articulating risks, assumptions, and trade-offs to program teams
- Oversee the design, execution, and interpretation of non-GLP and GLP toxicology studies
- Partner cross-functionally (DMPK, pharmacology, CMC, clinical) to integrate safety into development strategy
- Support diligence and evaluation of new programs within Flagship’s ecosystem
- Build and manage a high-performing CRO and consultant network, ensuring quality, timelines, and cost efficiency
- Leverage and contribute to the Flagship ecosystem, fostering knowledge sharing and collaboration across platform companies
- Lead nonclinical regulatory strategy and documentation (INDs, IBs, briefing materials)
- Ensure regulatory readiness through clear and scientifically robust safety narratives
- Represent toxicology in regulatory interactions as appropriate
- PhD, DVM, or equivalent in Toxicology, Pathology, Pharmacology, or related field
- 10-15+ years of experience in nonclinical safety in biotech/pharma
- Proven track record advancing programs through IND and into clinical development
- Experience across multiple modalities preferred
- Strong experience managing CROs and external collaborations
- Experience leading or building a toxicology function or team, including management of internal scientists and/or external partners, is a plus
- Enterprise mindset; able to operate across a portfolio in a fast-paced, collaborative environment
- Analytical and goal-oriented, with the ability to operate with urgency while maintaining high standards of scientific rigor and ethics
- Strong communicator who can translate complex toxicology into clear, audience-appropriate risk assessments, from early-stage teams to large pharma partners
The salary range for this role is $228,000 - $280,000. Compensation for the role will depend on a number of factors, including a candidate’s qualifications, skills, competencies, and experience. Pioneering Medicines currently offers healthcare coverage, an annual incentive program, retirement benefits, and a broad range of other benefits.
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