Senior Director, CMC Lead Product Development

Responsibilities

• Representing CMC (DS, DP, Analytical) in applicable governance forums
  • Serving as spokesperson and advocate for the CMC team
    • Ensuring transparent governance, bi-directional communication, cross functional ownership and proactive risk mitigation
  • Leading the cross functional CMC product development team meetings
    • Ensures information flow between CMC and all respective program and portfolio governance forums as applicable
  • Critically evaluates and integrates raw materials, drug substance and drug product inputs to development strategies
    • Ensures alignment with overall corporate business objectives
  • Leads one or more CMC project teams
    • Contributes to project prioritization at a portfolio level
      • Negotiates for additional resources when required
        • Influences project timelines to ensure proper completion of required activities
    • Mentors functional representatives
      • Provides feedback and input to their functional managers
        • Identifies growth needs for team members
    • Supports and contributes to the strategic direction of GSC&TO Program Management framework
      • Drives continuous improvement of the CMC Development Roadmap and Governance
        • Effectively collaborates across partner organizations
    • Serves as CMC Lead on high profile partnerships and collaborations
      • Drives joint decisions for the development programs
    • Communicates plans and risks proactively to GSC&TO/CMC and partner function senior leadership
      • Through regular communications and periodic reviews throughout development and in support of global filings, and approvals during the development life cycle
    • Leads and executes in alignment with ICH and applicable contemporary regulatory requirements

    Qualifications

    • Ph.D. in Chemistry, Pharmaceutical Sciences, Engineering, or related discipline with at least 10 years of development phase, drug product, drug substance, and/or analytical science experience; M.S. with 15+ years of relevant CMC experience required to effectively manage global teams and all CMC activities with respect to science, technology, quality, regulatory/compliance requirements, budget and resources
    • Critical experience/skillsets:
      • Small molecule API, formulation development, and/or analytical development and product development from pre-clinical through to commercial
    • Effective verbal communication at all levels throughout the organization
    • Strong working knowledge of current technical regulatory requirements and trends (ICH, FDA, EMA, MHRA, at a minimum)
    • Demonstrated knowledge and experience with project and program management, governance, and risk management
    • Negotiating, influencing, collaboration, and business acumen
    • Multiple product development experiences of leading a CMC team through IND and NDA/MAA preferred
    • Good scientific writing skills and good verbal skills
    • Knowledge of pharmaceutical sciences, chemical development, analytical development, and the drug development process
    • Multiple product development experiences of leading a CMC team through IND and NDA/MAA preferred
    • Promotes enterprise thinking and makes well informed business decisions while balancing risk
    • Experience across various asset modalities is desirable

    Pay Range

    In the U.S., the hiring pay range for fully qualified candidates is $261,000 - $304,500 per year. The base pay actually offered will take into account internal equity and also may vary depending on the candidate's geographic region, job-related knowledge, skills, and experience among other factors.