Senior Program Manager, Medical Product Development

This is a fully remote position, open to applicants in North Carolina.

📋 Description

• Oversee a portfolio of simultaneous development projects for drugs, biologics, medical devices, diagnostics, and combination products.

• Align scientific goals with project activities, timelines, resources, and budgetary considerations.

• Establish critical studies, tasks, deliverables, milestones, and dependencies in collaboration with multidisciplinary teams.

• Create and uphold project plans, monitor progress, and ensure accountability throughout the process.

• Identify technical and operational risks while coordinating appropriate mitigation strategies.

• Exercise judgment regarding project priorities and execution, escalating issues as necessary.

• Facilitate the transition of program responsibilities through effective knowledge transfer, documentation, and stakeholder continuity.

• Plan development activities and finalize study protocols and procedures in conjunction with investigators, scientists, CRO personnel, and consultants.

• Coordinate contributions in scientific, technical, regulatory, manufacturing, and commercialization domains.

• Facilitate activities across involved organizations and manage interdependencies effectively.

• Monitor deliverables from external partners and address any quality, schedule, or development concerns.

• Cultivate relationships with clients, investigators, technical specialists, and external service providers.

• Maintain clear communication among project teams, clients, and stakeholders.

• Lead project meetings, document decisions, and track actionable items.

• Research, compile, and summarize scientific and program information for requests, proposals, reports, presentations, and meetings.

• Communicate project status, risks, budgetary considerations, and necessary decisions to relevant parties.

• Assist in developing and monitoring project budgets and coordinating necessary adjustments.

• Manage conference calls, meetings, travel arrangements, and other logistical details.

• Support technology scouting and ecosystem mapping for AI trends and strategic investment and partnership decisions.

• Establish success metrics and feedback mechanisms for AI integration, tracking adoption, value realization, and preparedness.

• Advocate for responsible AI deployment, including human-in-the-loop validation, risk-aware experimentation, and governance alignment.

⛳️ Requirements

• Bachelor’s degree in a relevant scientific, engineering, or related field with 20+ years of experience in medical device or therapeutic product development; or a master’s degree with 15+ years of experience; or a PhD with 12+ years of experience.

• Proven experience in developing therapeutics, medical devices, diagnostics, or combination products.

• Ability to plan and coordinate intricate development activities, managing multiple projects or competing priorities simultaneously.

• Exceptional oral and written communication skills.

• Capacity to synthesize scientific and technical information and convey it clearly to diverse audiences.

• Strong interpersonal skills with a proven ability to collaborate effectively in multidisciplinary teams and across organizational boundaries.

• Excellent organizational skills, meticulous attention to detail, and consistent follow-through.

• Proficiency in Microsoft Word, Excel, PowerPoint, and Microsoft Project.

• Legally authorized to work in the United States.

• Must not require sponsorship for employment visa status, now or in the future.

• Preferred: Experience managing NIH-funded translational research or product development programs.

• Preferred: Background in preclinical and clinical product development.

• Preferred: Experience coordinating CROs, consultants, or other external development partners.

• Preferred: Familiarity with chemistry, manufacturing, and controls (CMC).

• Preferred: Experience in technical or scientific writing.

• Preferred: Experience supporting program transitions, transferring institutional knowledge, or taking responsibility for established project portfolios.

🏝️ Benefits

• Competitive base salary.

• Generous paid time off policy.

• Merit-based annual increases.

• Bonus opportunities.

• Robust recognition program.

• Health insurance.

• Dental insurance.

• Life insurance.

• Short-term disability insurance.

• Long-term disability insurance.

• Retirement savings program such as a 401(k) plan.

• Paid parental leave for all parents.

• Financial assistance with adoption expenses.

• Financial assistance with infertility treatments.

• Financial reimbursement for educational and developmental opportunities.

• Employee assistance program.

• Additional offerings to support a healthy work-life balance.