Pioneering Medicines: Project Toxicologist – Principal Scientist or Associate Director

What if... We could harness the power of Flagship’s scientific platforms and create novel treatment options that benefit more patients, sooner?

Pioneering Medicines, an initiative of Flagship Pioneering, is building a world-class biopharmaceutical R&D capability focused on conceiving and developing life-changing treatments for patients by harnessing the power of Flagship’s scientific platforms and applying those innovative approaches to serious diseases with unmet medical need. Unique to Pioneering Medicines’ approach is the opportunity to combine platforms to create truly novel and potentially transformative treatments. 

About Flagship Pioneering:

Flagship Pioneering conceives, creates, resources, and develops first-in-category life science platform companies to transform human health and sustainability. Since its founding in 2000, the firm has originated and fostered the development of more than 100 scientific ventures, resulting in over $34 billion in aggregate value, 500+ issued patents, and more than 50 clinical trials for novel therapeutic agents.  

Position Summary:

We are seeking a skilled and motivated individual to drive strategy and provide technical expertise in toxicology from discovery to development across our diverse drug discovery portfolio. The qualified candidate will provide project teams with toxicology strategy that is stage-appropriate. We are seeking individuals who are analytical, goal-oriented and committed to maintaining the highest scientific and ethical standards. Strong communication skills and comfort working in a dynamic, cross-functional team environment are highly desirable.

This role will be based at our Cambridge, MA location. We have a hybrid model and onsite presence 3 times per week is required.

Key Duties and Responsibilities include, not limited to, the following:

• Serve as the project toxicologist for projects at various stages of discovery and development
• Conduct safety assessments (on- and off-target)
• Contribute to study design, planning, execution, and monitoring of external non-GLP and GLP toxicology studies (in vitro and in vivo) studies
• Contribute to the development of an in silico and in vitro screening strategy to understand potential toxicological liabilities for new modalities
• Manage contracts and coordinate activities with CROs for non-GLP and GLP toxicology studies
• Support the preparation of study reports with external labs
• Lead the preparation of regulatory documents, including INDs, investigator’s brochures, and NDAs/BLAs
• Work closely with other functional areas such as biology, in vitro and in vivo pharmacology, DMPK, modeling and simulations, CMC and Clinical as well as internal and external collaborators

Qualifications & Skills:

• • BS/BA in toxicology, pharmacology, physiology, biology, immunology or related sciences with +10 years experience,
  • MA/MS in in toxicology, pharmacology, physiology, biology, immunology or related sciences with +8 years experience, or
  • D. in toxicology, pharmacology, physiology, biology, immunology or related discipline with +5 years experience in preclinical/nonclinical safety, pharmacology, and/or biology experience in the pharmaceutical/biotechnology industry
  • Strong lab, organization, and prioritizing skills to move programs forward
  • Strong critical thinking and analytical skills
  • Ability to learn quickly and creatively apply technologies (tried and true as well as new)
  • Ability to adapt to a rapidly changing and growing environment
  • Ability to multi-task and work with minimal guidance
  • Excellent oral/written communication and interpersonal skills
  • Ability to work well with team members from a broad range of levels and experience