Director, Program Management
Listed on 2026-02-11
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Management
Healthcare Management, Program / Project Manager
The Director of Program Management supports cross-functional teams such as R&D, QA, regulatory affairs, and manufacturing, ensuring compliance with regulatory guidelines, industry standards, and timely submission of regulatory applications and supplements. The role also supports regulatory and partner audits/inspections, maintains comprehensive project documentation, and stays updated on FDA laws, regulations, guidance, and regulatory precedent.
This position develops detailed project scope, budgets, and timelines; tracks and resolves scope changes; and communicates updates to stakeholders. The role coordinates and leads internal and external meetings and partners directly with Executive Leadership on new RFPs, business proposals, and customer site visits.
This position works closely with the Finance Department to develop and implement project budgeting tools while overseeing project budget adherence. The role is also responsible for the program management department budget, as well as leading and developing a team of project/program managers.
Education and Required Licenses or Certifications- Bachelor of Science degree in a related field required; MS/MBA preferred.
- PMP or other project management certification preferred.
- 10+ years of related experience, including at least 5 years managing pharmaceutical programs.
- Strong operational knowledge of the product development life cycle for new and generic drugs.
- Thorough understanding of FDA regulatory requirements, including the IND application process.
- Experience communicating directly with regulatory agencies.
- Proven leadership, organizational, and communication skills; demonstrated team leadership and ability to meet objectives.
- Proficiency in Microsoft Word, Excel, PowerPoint, Outlook, and project management software/tools.
- Ability to interact with individuals at all levels, including external partners and regulatory authorities.
- Strong problem-solving, analytical and strategic thinking abilities.
- Sound decision-making abilities.
- Ability to plan over a 12-to-24-month time span and manage multiple projects simultaneously.
- Detail-oriented and self-directed.
- Ability to coach, mentor, and provide constructive feedback.
- Excellent interpersonal and communication skills; strong team player.
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