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Senior Director of Pharmaceutical Development

2 months ago

Reston, Virginia, United States The Higgins Group, Inc. Full time
About the Role

We are seeking a highly experienced and skilled professional to lead our Pharmaceutical Development and Manufacturing (PDM) organization as Vice President, Drug Product. This key role will be responsible for formulation development and drug product manufacturing operations in support of clinical development and commercialization of our pipeline compounds.

Key Responsibilities
  • Lead formulation development and drug product manufacturing operations from early to late development through commercialization
  • Develop and execute strategies for formulation development and drug product manufacturing, ensuring seamless execution and alignment with integrated product development plans and program timelines
  • Author and review CMC sections for global regulatory filings, ensuring compliance with FDA, EMA, and ICH guidelines
  • Lead cross-functional CMC teams to ensure adequate development and execution of CMC plans and strategies
  • Collaborate with cross-functional teams to ensure CMC and program goals are met, including process R&D, analytical development, supply chain, quality, clinical, regulatory, DMPK, and tox
Requirements
  • PhD in Pharmaceutics, Chemistry, Chemical Engineering, or closely related field (MSc degree minimum)
  • Substantial experience in pharmaceutical/biotech industry with technical expertise and organizational leadership in early and late phase formulation development and drug product manufacturing
  • Extensive experience in late phase drug product development and commercial launch with global CMC regulatory filings (IND/NDA/MAA)
  • Proven track record of strategic leadership and management with at least 10 years of management experience
  • Demonstrated strong project and cross-functional team leadership, as well as people management skills
  • Thorough understanding and working experience of drug product development and manufacturing with respect to GMP, quality systems, ICH guidelines, FDA, EMA, and associated regulatory requirements