The Sr. Director / Executive Director, Program Management will serve as the program management lead for small molecule drug development programs, with deep responsibility for Chemistry, Manufacturing, and Controls (CMC). This role partners closely with the corporate program management and functional leaders across CMC, Clinical, Regulatory, Nonclinical, Translational, Quality, and Commercial to ensure integrated, end-to-end development and execution of assets from pre-IND through NDA approval and commercialization.
Must have 10–15+ years of experience in pharmaceutical or biotechnology companies leading drug development or program management activities.
Responsibilities include, but are not limited to:
- Lead integrated, cross-functional small molecule drug development teams with strong emphasis on CMC strategy and execution, including drug substance, drug product, analytical development, formulation, process development, manufacturing, supply chain, and quality.
- Act as the primary program management partner to corporate program management and CMC leadership, ensuring technical development, manufacturing readiness, and regulatory strategies are fully aligned with overall asset strategy and corporate objectives.
- Develop and maintain integrated development plans covering, regulatory, and CMC activities across discovery, IND-enabling, early clinical, late-stage development, and commercialization.
- Drive CMC execution for small molecules including candidate selection support, IND-enabling activities, tech transfer to internal and external manufacturing, clinical supply strategy, scale-up, validation, and lifecycle management.
- Partner closely with Regulatory Affairs to align small molecule CMC strategies for global IND, CTA, NDA filings, and health authority interactions.
- Lead proactive identification and mitigation of program risks with particular focus on CMC, manufacturing robustness, supply continuity, and GMP compliance.
- Prepare clear, data-driven program updates, dashboards, and decision materials for governance committees and executive leadership.
- Coordinate and oversee external partners including CDMOs, testing labs, and development vendors to ensure timely delivery of CMC and development milestones.
- Ensure consistent program execution disciplines, meeting excellence, documentation, and communication across all development functions.
- Contribute to continuous improvement of program management best practices, SOPs, tools, and governance models tailored to small molecule development.
Required Qualifications & Experience
- Advanced scientific degree (BS/MS/PhD) in chemistry, chemical engineering, pharmaceutical sciences, or related field; MBA and/or PMP certification preferred.
- 10–15+ years of experience in pharmaceutical or biotechnology companies leading drug development or program management activities.
- Demonstrated expertise in small molecule drug development with strong hands-on involvement in CMC-driven programs across multiple clinical phases.
- Deep understanding of small molecule CMC, including synthetic chemistry, solid-state and formulation development, analytical development, manufacturing scale-up, tech transfer, GMP operations, and CMC regulatory requirements.
- Proven ability to lead complex, global, cross-functional teams in matrixed environments and drive execution without direct authority.
- Experience managing external partnerships and CDMOs supporting drug substance and drug product development and commercial supply.
- Strong leadership, communication, and executive presence, with the ability to synthesize complex technical information for senior decision-making.
- Track record of operating effectively in fast-paced, ambiguous environments with multiple concurrent programs.
Preferred Background
- Extensive background leading global, cross-functional development teams spanning clinical, regulatory, and CMC for small molecule programs from discovery or preclinical through NDA approval and commercialization.
- Prior experience directly leading or partnering with CMC organizations responsible for drug substance and drug product development, manufacturing, and technical transfer.
- Experience overseeing Phase 1–3 development programs, including late-stage registration and NDA/MAA submissions.
- Hands-on experience working with global CDMOs and manufacturing partners, including oversight of GMP operations and supply chain readiness.
- Early-career or direct experience in pharmaceutical development, chemistry, formulation, or manufacturing providing strong technical foundation for CMC leadership.
- Demonstrated success driving integrated program strategy, governance, and risk management across complex portfolios.
- Experience working closely with executive leadership teams and contributing to enterprise-level development and portfolio decisions.
- Excellent organizational skills and an ability to prioritize effectively to deliver results within reasonably established timelines
- Proven ability to manage competing priorities in a fast-paced, rapid-growth environment
- Ability to work independently and collaboratively adapt as part of a team
- Strong interpersonal skills, including verbal and written communication
- Candidates must be authorized to work in the U.S.
- Travel may be required up to 10%