Director, Pharmaceutical Development

Fulcrum Therapeutics is seeking a Director of Pharmaceutical Development to lead all drug product development activities, including formulation development, manufacture of clinical trial material, and validation. The successful candidate will lead strategic and tactical aspects of drug product development, collaborate with colleagues, and ensure compliance with Regulatory and Quality requirements.

Requirements

• D with 10 years or MS with equivalent years of experience
• Professional background in Pharmaceutical Sciences (preferred) or Chemical Engineering
• Proven track record and leadership in phase-appropriate drug development through pivotal studies (required) and approval (preferred)
• SME in material science aspects of dosage forms and drug delivery, with emphasis on solid oral dosage forms; strong knowledge in Dissolution, Biopharmaceutics and PK
• Well versed in Regulatory CMC and ICH guidance, including exposure to FDA interactions (e.g. via EOP2 or preNDA meetings)
• Strong written and oral communication skills; highly effective collaborator with “customers” in ClinOps and Commercial
• Ability to hire and recruit staff, including key contractors and consultants
• Positive work presence; responds to stress and ambiguity with humor

Benefits

• Generous Paid Time Off
• 401k Matching
• Health Insurance
• Dental Insurance
• Vision Insurance