Pioneering Medicines | Cambridge, MA Pioneering Medicines: Director, Project Toxicology - Flagship Pioneering : Job Details

Cambridge, MA USA

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 Toxicologist 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. 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, but are 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:

• MA/MS in toxicology, pharmacology, physiology, biology, immunology, or related sciences
• PhD in toxicology, pharmacology, physiology, biology, immunology, or related discipline
• 5+ years of experience in preclinical/nonclinical safety, pharmacology, and/or biology experience in the pharmaceutical/biotechnology industry
• Safety assessment experience (on- and off-target)
• Understanding of early discovery Toxicology and Regulatory Toxicology
• Project Toxicology strategy experience for small molecules, biologics, and/or gene therapies moving to IND
• Ability to provide Toxicology expertise across a wide variety of Therapeutic areas such as Metabolism, Oncology, Immunology, Renal, and Cardiovascular

Flagship Pioneering and our ecosystem companies are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity, or Veteran status.