Director, Pharmaceutical Development

Company Overview 

Fulcrum Therapeutics, Inc. (“Fulcrum”) [NASDAQ: FULC] is a clinical-stage biopharmaceutical company focused on developing small molecules to improve the lives of patients with genetically defined rare diseases. Fulcrum is deeply committed to bringing hope and new options to patients suffering from rare hematologic disorders and is developing a pipeline of clinical and preclinical assets. Fulcrum’s lead clinical asset is pociredir, a first-in-class small molecule designed to increase the expression of fetal hemoglobin for the treatment of sickle cell disease and other hemoglobinopathies. We are working to expand our portfolio of clinical-stage assets and seek a driven and strategic leader to head our Pharmaceutical Development function.

Description

Reporting to the Head of Technical Operations, the Director of Pharmaceutical Development will lead all drug product development activities including technical, managerial, and budgetary aspects. This includes formulation development, manufacture of clinical trial material, process optimization, scale-up, and validation. The successful candidate will lead, plan and manage the technical and business-related activities associated with 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 contract manufacturing organizations (CMOs), assuring 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 documents related to Drug Product (formulation, process development, manufacturing, etc.) for Regulatory submissions (IND/IMPD and NDA/MAA)

Qualifications

• 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