Director, Pharmaceutical Development
Fulcrum Therapeutics
5 months ago
Remote friendly (Cambridge, MA)
United States
Operations
Director of Pharmaceutical Development
Description
- Reporting to the Head of Technical Operations, lead all drug product development activities including technical, managerial, and budgetary aspects.
- Oversee formulation development, manufacture of clinical trial material, process optimization, scale-up, and validation.
- Lead, plan, and manage technical and business-related activities for drug product development and manufacturing at contract development and manufacturing vendors for all dosage form programs.
Key Responsibilities
- Lead all strategic and tactical aspects of drug product development at Fulcrum
- Design and execute pharmaceutical product development plans for all development programs in accordance with corporate goals
- Collaborate with colleagues in Drug Substance, Analytical, ClinOps, QA, and Reg CMC to ensure plans are cross-functional, phase-appropriate, and on time
- Lead pharmaceutical development for the pociredir program, including CTM for pivotal clinical studies, pre-validation studies, validation plans, and commercial launch supply
- Lead and manage product development, technology transfer, and clinical manufacturing activities at CMOs, ensuring compliance with Regulatory and Quality requirements
- Lead pediatric formulation development efforts, as required
- Review and approve a broad spectrum of documents (MBRs, Specifications, Protocols, Reports, etc.) at CMOs
- Generate, review, and approve Drug Product documents (formulation, process development, manufacturing, etc.) for Regulatory submissions (IND/IMPD and NDA/MAA)
Qualifications
- Doctorate with 10 years or MS with equivalent years of experience; background in Pharmaceutical Sciences (preferred) or Chemical Engineering
- Proven 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; exposure to FDA interactions (e.g., EOP2 or preNDA meetings)
- Strong written and oral communication skills; effective collaborator with ClinOps and Commercial
- Ability to hire and recruit staff, including key contractors and consultants
- Positive work presence; responds to stress and ambiguity with humor
Compensation
- Base salary pay range: $240,000—$240,000 USD
Description
- Reporting to the Head of Technical Operations, lead all drug product development activities including technical, managerial, and budgetary aspects.
- Oversee formulation development, manufacture of clinical trial material, process optimization, scale-up, and validation.
- Lead, plan, and manage technical and business-related activities for drug product development and manufacturing at contract development and manufacturing vendors for all dosage form programs.
Key Responsibilities
- Lead all strategic and tactical aspects of drug product development at Fulcrum
- Design and execute pharmaceutical product development plans for all development programs in accordance with corporate goals
- Collaborate with colleagues in Drug Substance, Analytical, ClinOps, QA, and Reg CMC to ensure plans are cross-functional, phase-appropriate, and on time
- Lead pharmaceutical development for the pociredir program, including CTM for pivotal clinical studies, pre-validation studies, validation plans, and commercial launch supply
- Lead and manage product development, technology transfer, and clinical manufacturing activities at CMOs, ensuring compliance with Regulatory and Quality requirements
- Lead pediatric formulation development efforts, as required
- Review and approve a broad spectrum of documents (MBRs, Specifications, Protocols, Reports, etc.) at CMOs
- Generate, review, and approve Drug Product documents (formulation, process development, manufacturing, etc.) for Regulatory submissions (IND/IMPD and NDA/MAA)
Qualifications
- Doctorate with 10 years or MS with equivalent years of experience; background in Pharmaceutical Sciences (preferred) or Chemical Engineering
- Proven 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; exposure to FDA interactions (e.g., EOP2 or preNDA meetings)
- Strong written and oral communication skills; effective collaborator with ClinOps and Commercial
- Ability to hire and recruit staff, including key contractors and consultants
- Positive work presence; responds to stress and ambiguity with humor
Compensation
- Base salary pay range: $240,000—$240,000 USD