Pioneering Medicines Senior Director, Head of Toxicology

What if...We could harness the power of Flagships scientific platforms and create novel treatment options that benefit more patients sooner

ABOUT PIONEERING MEDICINES

Pioneering Medicines Flagship Pioneerings in-house drug development unit is dedicated to conceiving and developing a broad portfolio of life-changing treatments for patients built from Flagships innovative platforms. Harnessing the drug development expertise of its team together with the power of Flagships multiple scientific platforms Pioneering Medicines explores and identifies new product concepts which are then advanced jointly with Flagships bioplatform companies. Within Flagships Innovation Supply Chain partnerships Pioneering Medicines works with external collaborators to apply its unique approach to partners R&D priorities. These partnerships are highly co-creative strategic alliances that accelerate therapeutic innovation by bringing together partners spanning the full spectrum of drug discovery development and production.

Position Summary

The Senior Director Head ofToxicologywill 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 tooptimizecandidateselection 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

Functional Leadership & Capability Building

• 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

Portfolio & Program Strategy

• 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 ofnewprogramswithin Flagships ecosystem

External Partnerships & Regulatory

• 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

• Proventrack recordadvancing 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 tooperateacross a portfolio in a fast-paced collaborative environment

• Analytical and goal-oriented with the ability tooperatewith urgency whilemaintaininghigh standardsof 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

About Flagship

Flagship Pioneering is a scientific innovation engine that invents and builds companies that change the world. We bring together the greatest scientific minds with entrepreneurial company builders and assemble the capital to allow them to take courageous leaps in human health sustainability and beyond.

What sets Flagship apart is our ability to advance biotechnology by uniting life science innovation company creation and capital investment under one roof in a way that islargely withoutprecedent. Our team of scientists entrepreneurial leaders and professional capital managersare eachaligned around an institutionalized process that enables us to innovate and create breakthroughs for the benefit of people andplanet. Many of the companies Flagship has founded have addressed humanitys most urgent challenges: vaccinating billions of people against COVID-19 curing intractable diseases improving human health preempting illness and feeding the world by improving the resiliency and sustainability of agriculture.

Flagship has been recognized twice on FORTUNEs Change the World list an annual ranking of companies that have made a positive social and environmental impact through activities that are part of their core business strategies and has been named four times to Fast Companys annual list of the Worlds Most Innovative Companies.

At Flagship we recognize there is no perfect candidate. If you have some of the experience listed above but not all please apply anyway. Experience comes in manyformsskills are transferable and passion goes a long way. We are dedicated to building diverse and inclusive teams and look forward to learning more about your unique background.

Recruitment & Staffing Agencies: Flagship Pioneering and its affiliated Flagship Lab companies (collectively FSP) do not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to FSP or its employees is strictly prohibited unless contacted directly by Flagship Pioneerings internal Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of FSP and FSP will not owe any referral or other fees with respect thereto.

The salary range for this role is $228000 - $280000. Compensation for the role will depend on a number of factors including a candidates qualifications skills competencies and experience. Pioneering Medicines currently offers healthcare coverage annual incentive program retirement benefits and a broad range of other benefits. Compensation and benefits information is based on Pioneering Mediciness good faith estimate as of the date of publication and may be modified in the future.

Privacy Notice for Applicants:When you apply for a role at Flagship Pioneering or one of its portfolio companies we collect and use personal information you provide (such as your name contact details work history and application materials) to evaluate your application communicate with you and comply with legal obligations. Your application data is processed through Greenhouse our applicant tracking system and may also be reviewed using AI-assisted screening tools. We do not sell your personal information. California residents have rights under the CCPA/CPRA including to know delete and opt out of the sharing of their personal information. If you are located in the EU or UK we process your data under GDPR and you have rights to access rectify and erase your data. To exercise your rights or for questions contact