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Director of Pharmaceutical Development

On-site Full-time $240K/yr - $240K/yr

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Experience Level

Senior Level Manager

Qualifications

Qualifications PhD in Pharmaceutical Sciences with a minimum of 10 years of relevant experience, or MS with an equivalent number of years in a related field. Extensive background in pharmaceutical product development, with a strong emphasis on drug formulation and manufacturing processes. Proven leadership skills with the ability to manage cross-functional teams and budgets effectively. Experience working with contract manufacturing organizations (CMOs) and regulatory submissions. Exceptional communication and interpersonal skills, capable of fostering collaboration among diverse teams. Strong analytical and problem-solving capabilities.

About the job

Fulcrum Therapeutics, Inc. (NASDAQ: FULC) is a pioneering clinical-stage biopharmaceutical company dedicated to developing innovative small molecules aimed at enhancing the lives of patients with genetically defined rare diseases. Our mission is to instill hope and offer new treatment options for individuals affected by rare hematologic disorders. We are actively advancing a robust pipeline of clinical and preclinical assets, with our flagship product, pociredir, being a first-in-class small molecule designed to elevate fetal hemoglobin levels in the treatment of sickle cell disease and other hemoglobinopathies. As we expand our portfolio of clinical-stage assets, we are seeking a dynamic and strategic leader to oversee our Pharmaceutical Development function.

Job Description

As the Director of Pharmaceutical Development, you will report directly to the Head of Technical Operations. You will spearhead all drug product development initiatives encompassing technical, managerial, and financial dimensions. Your responsibilities will include formulation development, clinical trial material production, process optimization, scale-up, and validation. The ideal candidate will adeptly lead, plan, and manage both the technical and business-related components associated with drug product development and manufacturing at contract development and manufacturing organizations (CDMOs) for various dosage form programs.

Key Responsibilities

  • Direct and oversee all strategic and operational facets of drug product development at Fulcrum.
  • Design and implement pharmaceutical product development plans aligned with corporate objectives for all development programs.
  • Collaborate with cross-functional teams, including Drug Substance, Analytical, Clinical Operations, Quality Assurance, and Regulatory CMC, to ensure that plans are comprehensive, phase-appropriate, and executed on schedule.
  • Lead pharmaceutical development efforts for the pociredir program, covering clinical trial material for pivotal studies, pre-validation studies, validation plans, and commercial launch supply.
  • Manage product development, technology transfer, and clinical manufacturing activities at contract manufacturing organizations (CMOs), ensuring adherence to Regulatory and Quality standards.
  • Oversee pediatric formulation development initiatives as needed.
  • Review and approve a wide range of documents (e.g., MBRs, Specifications, Protocols, Reports) at CMOs.
  • Generate, review, and approve documentation related to Drug Product (formulation, process development, manufacturing) for Regulatory submissions (IND/IMPD and NDA/MAA).

About Fulcrum Therapeutics, Inc.

Fulcrum Therapeutics, Inc. is at the forefront of biopharmaceutical innovation, devoted to advancing treatment options for patients with rare diseases. With a focus on developing small molecules that target genetically defined conditions, Fulcrum is committed to improving patient outcomes and transforming lives.

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