PURPOSE

The Company is seeking a Project Manager, Medical Affairs to own the planning, coordination, and execution of key Medical Affairs work streams as the product candidate approaches its U.S. launch H1 2027 for the target therapeutic area, with the program advancing toward a future a future indication indication. Reporting to the Head of Medical Affairs, this role is responsible for driving project management across advisory councils, publication and abstract submissions, patient support programs, and real-world evidence planning - designed for someone energized by structure, follow-through, and cross-functional coordination. As the Medical Affairs organization scales through launch, there is scope for this role to expand into additional work streams. All activities will be conducted with the highest standards of compliance, integrity, and ethical responsibility.

PURPOSE

Key Responsibilities

Advisory Councils & Stakeholder Engagement

Own end-to-end project management of the Clinical Council and associated advisory board meetings, including timelines, contracts, logistics, materials coordination, and follow-up tracking
Manage stakeholder mapping and KOL engagement timelines in partnership with cross-functional teams
Coordinate meeting minutes and advisory council follow-up actions

Scientific Communications & Publications

Own project management of the publication strategy and congress activities as they evolve, including biostatistics data request timelines, abstract and manuscript timelines, author coordination, and journal submissions
Manage congress deliverable execution - Medical booths, abstracts, posters, and slide decks - ensuring on-time, compliant delivery

Compliance & Operations

Support management of MLR review completion
Ensure execution of compliance requirements, such as Fair Market Value documentation and Sunshine Act reporting
Plan and ensure team delivery of the development and implementation of onboarding and training plans as the team scales

Cross-Functional Project Infrastructure & Scope for Growth

Develop and maintain project tracking systems, timelines, and status reporting across owned Medical Affairs work streams
As the organization scales through launch, opportunity to expand ownership into additional work streams, such as real-world evidence planning and supporting the intake, review, tracking, and documentation of Investigator Initiated Trial inquiries
Significant opportunity for professional growth within Medical Affairs as the organization scales, with potential to expand into additional work streams beyond project management based on demonstrated performance

Qualifications And Education

Advanced degree in a relevant scientific discipline is desired
Relevant project management experience in research, pharmaceutical, or biotech environment; pre-launch or launch experience preferred
Demonstrated experience and understanding across areas such as publication planning and delivery, congress logistics, advisory council planning and execution, or other medical affairs pillars
Familiarity with MLR review processes and compliant scientific engagement
Formal project management training a plus

Knowledge, Skills And Abilities

Strong project management, organizational, and prioritization skills across multiple concurrent work streams
Strong understanding of medical affairs deliverables
Comfortable operating autonomously in a fast-paced, pre-launch environment
Effective cross-functional communicator able to align stakeholders around timelines and deliverables
Detail-oriented, with strong documentation and tracking discipline
Collaborative team player with the ability to partner cross-functionally and build strong working relationships
Demonstrated understanding of the therapeutic area or an adjacent therapeutic area is a plus

TRAVEL

Approximately 10-30% for advisory board meetings, team meetings, and key external engagements.

Job Identifier: #10330

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