Pioneering Medicines: Senior /Executive Director, Head of Toxicology

About the role

Join Flagship Pioneering's innovative in-house drug development team, Pioneering Medicines, as the Senior Director, Head of Toxicology. In this leadership role, you will be responsible for shaping and expanding the toxicology function, ensuring the development and implementation of robust nonclinical safety strategies across a diverse portfolio of therapeutic candidates. You will serve as the scientific authority on investigative and regulatory toxicology, providing strategic guidance and oversight to internal teams and external partners. Your work will be critical in supporting candidate selection, advancing preclinical development, and ensuring regulatory compliance. This position offers an exciting opportunity to influence the safety assessment processes for cutting-edge therapies within a collaborative and forward-thinking environment.

Key facts

What you'll do

• Lead the development and expansion of the toxicology department, including recruiting top talent, establishing internal processes, and building external collaborations with CROs and consultants.
• Design and implement comprehensive operational models for investigative and regulatory toxicology activities, ensuring alignment with company goals and regulatory standards.
• Act as the primary internal authority on nonclinical safety, providing expert guidance on toxicology data interpretation, safety assessments, and risk evaluations.
• Develop strategic toxicology plans tailored to various therapeutic modalities, including small molecules, biologics, and novel platforms, supporting the progression of candidates through preclinical phases.
• Oversee the planning, execution, and interpretation of non-GLP and GLP toxicology studies, ensuring scientific rigor and regulatory compliance.
• Collaborate closely with cross-functional teams - including pharmacology, chemistry, clinical development, and regulatory affairs - to integrate safety data into overall development strategies.
• Prepare and review safety narratives, study reports, and regulatory documentation, including IND submissions and briefing packages, to facilitate smooth regulatory interactions.
• Communicate complex toxicology findings and their implications clearly to internal stakeholders, including senior management and external partners, to inform decision-making processes.
• Support the evaluation of new programs within Flagship's ecosystem by assessing safety profiles and advising on development pathways.
• Establish and maintain relationships with CROs and external consultants, ensuring high-quality, timely delivery of toxicology studies and data.
• Represent the company in regulatory discussions related to toxicology and safety assessments, contributing to the development of regulatory strategies.
• Stay current with evolving toxicology and regulatory science standards, incorporating best practices into the company's safety assessment processes.
• Lead efforts to prepare for and respond to regulatory inspections and audits related to toxicology activities.
• Foster a culture of scientific excellence, collaboration, and continuous improvement within the toxicology team.

Requirements

• A PhD, DVM, or equivalent degree in Toxicology, Pathology, Pharmacology, or a related discipline.
• Approximately 10-15 years of experience in nonclinical safety within the biotech or pharmaceutical industry, with a proven track record of guiding programs through IND submission and into clinical development.
• Extensive experience designing, managing, and interpreting toxicology studies, including GLP and non-GLP work.
• Demonstrated ability to develop and implement strategic toxicology plans aligned with regulatory requirements.
• Strong understanding of regulatory frameworks governing toxicology and safety assessments, including FDA, EMA, and other global agencies.
• Proven leadership skills, including building and managing teams, and establishing external partnerships with CROs and consultants.
• Excellent scientific communication skills, with the ability to articulate complex data clearly and effectively to diverse audiences.
• Experience preparing regulatory documents, safety narratives, and briefing packages.
• Ability to work collaboratively across multidisciplinary teams and influence decision-making at senior levels.
• Strong problem-solving skills and attention to detail.
• Knowledge of current toxicology methodologies, safety assessment practices, and emerging trends in the field.

Nice to have

• Experience working with a variety of therapeutic modalities, including biologics, gene therapies, or novel platforms.
• Prior experience in a biotech or pharmaceutical setting with a focus on innovative or early-stage therapies.
• Familiarity with advanced toxicology techniques, such as in vitro models or biomarker development.
• Experience managing external CROs and negotiating study scope and budgets.
• Knowledge of global regulatory submission processes and interactions.
• Background in working within a fast-paced, innovative environment that emphasizes scientific excellence and agility.

Skills & tools

• Expertise in toxicology, nonclinical safety, and regulatory science.
• Proficiency in designing and interpreting toxicology studies, including GLP and non-GLP work.
• Skills in risk assessment, safety evaluation, and mitigation strategies.
• Strong leadership and team-building capabilities.
• Excellent written and verbal communication skills for scientific and regulatory audiences.
• Ability to develop and implement strategic plans and operational workflows.
• Familiarity with current toxicology software, data management systems, and regulatory submission tools.
• Ability to stay updated on evolving scientific standards and regulatory requirements.

Practical notes

• Visa sponsorship is not available for this position.
• The role involves on-site work at the Cambridge, MA office, with flexible arrangements for remote work for eligible candidates.
• The position offers a competitive salary and comprehensive health benefits package.
• Candidates interested in applying should submit their applications by [insert application deadline].
• The role involves working with sensitive and regulated information, requiring compliance with ITAR regulations.
• The successful candidate will be expected to contribute to a collaborative, innovative environment focused on advancing transformative therapies.