Associate Director, Program Management – Clinical, Medical & Regulatory

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

📋 Description

• Oversee strategic planning, execution, and delivery of clinical programs across Clinical Development, Clinical Operations, Biometrics, Medical Affairs, and Regulatory.

• Align program planning and execution with corporate goals and the Product Development Team's strategy.

• Establish project scope, timelines, budgets, and resource plans throughout the clinical portfolio.

• Lead cross-functional study teams and governance meetings, managing agendas, decision logs, minutes, and action item tracking.

• Create and maintain project plans, timelines, and dashboards for various clinical programs.

• Identify, assess, and communicate risks utilizing risk registers along with mitigation and contingency strategies.

• Oversee CROs, vendors, and external partners, including performance management, contracts, issue resolution, and vendor governance.

• Assist in the preparation and submission of regulatory filings, such as INDs and BLAs.

• Prepare and deliver project updates to senior management and stakeholders.

• Collaborate with Finance and Legal to ensure timely and budget-compliant milestone delivery.

• Develop and utilize PM tools and templates to enhance enterprise PMO best practices.

• Act as a Smartsheet Super User by creating and publishing plans, dashboards, and reports, as well as training team members.

• Work across time zones as needed; travel of 10–15% may be required.

⛳️ Requirements

• Required experience in the pharmaceutical or biotechnology industry.

• Minimum of 7 years of program management experience for Sr. Manager level; 8+ years for Associate Director level.

• Direct experience in supporting regulatory Health Authority Inspections in a GxP-regulated setting is essential.

• Proficiency in MS Office, including Outlook, PowerPoint, Excel, and Word, along with familiarity with project management tools.

• Strong grasp of PM best practices, PMO operating models, and scalable processes.

• Extensive experience with Smartsheet, including the creation, maintenance, and reporting of timelines, Gantt charts, dashboards, and reports.

• Experience in managing vendor relationships and contracts.

• Excellent verbal and written communication abilities.

• Capability to manage multiple tasks and priorities effectively.

• Ability to work both independently and collaboratively with cross-functional teams.

• Experience in clinical trial environments within biotech or cell and gene therapy.

• An advanced degree in Life Sciences is preferred.

• Project management certification, such as PMP or CAPM, is preferred.

• Experience with early- and late-stage clinical programs is advantageous.

• Preferred experience in cell and gene therapy, CAR-T, or similar industries.

• Authorization to work in the United States is addressed in the application.

🏝️ Benefits

• Competitive benefits package.

• Paid Time Off (PTO).

• Stock option plans.

• Commitment to employee well-being and ongoing growth.

• A company certified as a Great Place to Work.