Position OverviewThe Program Management Contractor will lead planning, coordination, and execution of cross-functional development activities spanning pre-IND through commercial planning. This individual will partner closely with functional leaders to develop integrated development plans, maintain program timelines, manage key deliverables, and facilitate effective cross-functional decision-making.
The successful candidate will be responsible for driving program governance, maintaining an integrated project plan, identifying and mitigating risks, and ensuring alignment across Clinical Development, Regulatory Affairs, Technical Operations, Nonclinical Development, Data Management, and other functional groups.
This individual will thrive in a highly matrixed, fast-paced biotechnology environment and bring strong operational leadership, communication, and project management expertise to support successful program execution.
What You'll BringCommunication- Demonstrated ability to build strong partnerships across cross-functional teams and external stakeholders.
- Excellent verbal and written communication skills with the ability to balance inquiry, collaboration, and influence when solving complex challenges.
Organization- Highly organized with exceptional attention to detail.
- Proven ability to develop and maintain integrated project plans while aligning multiple functional workstreams.
- Experience establishing program management processes that improve execution and cross-functional collaboration.
Leadership & Collaboration- Strong facilitator who drives productive discussions and aligns diverse stakeholders around common objectives.
- Comfortable challenging assumptions, facilitating decision-making, and fostering accountability across teams.
Adaptability- Demonstrated success managing multiple priorities within a dynamic, rapidly evolving biotechnology environment.
Key Responsibilities- Lead execution of integrated cross-functional development plans from early development through key clinical milestones.
- Develop and maintain comprehensive project plans, timelines, milestones, interdependencies, budgets, and critical path analyses.
- Coordinate activities across Clinical Development, Regulatory Affairs, Nonclinical Development, Technical Operations/CMC, Data Management, Quality, and other functional groups.
- Facilitate recurring cross-functional team meetings to ensure alignment, accountability, and timely decision-making.
- Monitor project progress, proactively identify risks, and implement mitigation strategies to support program objectives.
- Prepare and present program updates, status reports, and key metrics to senior leadership and governance committees.
- Drive cross-functional communication and operational excellence to support successful execution of development programs.
Qualifications- Bachelor's degree in Life Sciences or a related scientific discipline required; advanced degree (MBA or equivalent) preferred.
- Approximately 6-8 years of biotechnology or pharmaceutical industry experience, including 2-4 years of program or project management supporting drug development programs.
- Experience supporting early-stage clinical development programs from preclinical or IND-enabling activities through early clinical development.
- Demonstrated success leading cross-functional teams within a matrixed organization.
- Strong understanding of drug development, including preclinical development, IND-enabling activities, regulatory submissions, and early clinical trial execution.
- Experience supporting advanced therapeutic modalities (such as gene editing, gene therapy, cell therapy, or other novel platforms) is preferred but not required.
- Proficiency with project management tools such as Smartsheet, Microsoft Project, OnePager, or similar project planning platforms.
- Experience managing multiple development programs simultaneously is preferred.
