Program Manager, Regulatory Program Development

Seeking a Program Manager with Regulatory Program Development experience for a contract role to help support the development of an IND and ultimately an NDA for a DOD sponsored program. The individual must collaborate cross-functionally with Pharmatech SMEs and client to align resources and drive results. This is a contract remote role but will involve support for interactions with the Client, COC and FDA as needed for meetings.

What You’ll Do

• Manage the execution of deliverables, both short and long-term, via clearly defined milestones, and timelines. Minimize timeline deviations by clearly identifying program risks and communication of strategies.
• Work closely with the client and Pharamtech project teams to develop the Pre-IND package, IND and NDA for the first indications
• Work closely with the project coordinator to manage budget, resources and deliverables.
• Aggregate information to enable program level prioritization discussions.
• Make schedule contingencies visible and develop assessment of contingency trade-offs to enable decisions on optimal path forward.
• Constructively escalate issues and decisions to Pharmatech’s program liaison as necessary. Proactively communicate key issues and any other critical topics in a timely manner to the appropriate management level and/or to any other relevant project team member(s).
• Develop and maintain overall team dashboard, schedule, project plans, operational plans, and routine reports to sponsors and stakeholders for all four products. Partner with finance to support budget processes

Requirements

• Bachelor’s Degree with at least 10 years relevant biotech/pharmaceutical experience with a strong understanding of the drug development process and commercial launch process
• Strong cross-functional leadership in a matrix environment, with advanced skills in project and program management, organizational, delegation, prioritization, and facilitation.

• Experience in managing product development and regulatory programs
• Strong communication skills with the ability to adapt communications to the audience.
• Familiarity with Fast-Track, Orphan Drug and the Emergency Use Authorization process a plus.
• Strong interpersonal skills to elicit, synthesize, and manage the cross-functional inputs required for a robust development plan.
• Experience with managing product development activities for an IND and NDA

Pharmatech Associates, Inc. provides equal employment opportunity to all individuals regardless of their race, color, creed, religion, gender, age, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by state, federal, or local law.