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Pioneering Medicines: Senior Director, Head of Toxicology

Job in Cambridge, Middlesex County, Massachusetts, 02140, USA
Listing for: Dormont Manufacturing Co
Full Time position
Listed on 2026-07-03
Job specializations:
  • Business
    Regulatory Compliance Specialist
Salary/Wage Range or Industry Benchmark: 228000 - 280000 USD Yearly USD 228000.00 280000.00 YEAR
Job Description & How to Apply Below

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
Qualifications
  • 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
Leadership Profile
  • 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
Benefits

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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Position Requirements
10+ Years work experience
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