Director, US Medical Affairs Strategic Operations

The Opportunity:

The Director of US Medical Affairs Operations will be instrumental in enabling medical impact through operational leadership, strategic planning, process and systems enablement across the full product lifecycle and portfolio. Reporting to the VP, Medical Affairs, this highly visible role drives planning, integration, execution, and governance of medical affairs activities across the US Medical Affairs portfolio. As a core member of the USMA Leadership Team, this role ensures that strategy is translated into coordinated, high-impact execution across US cross-functional stakeholders. This role will collaborate across internal teams and external partners to deliver compliant, efficient, and scalable solutions that support medical strategy, launch readiness, and scientific exchange in the US Region.

Key responsibilities include:

Strategic Operations Leadership & Execution Management

• Translate Medical Affairs strategy into aligned goals and cross-functional plans spanning scientific engagement, communications, evidence generation, and launch readiness; enable alignment between US and Global strategies and drive clarity on priorities and execution.

• Partner with the Head of US Medical Affairs, Global Medical Affairs, Global Commercialization, US Commercial and Market Access, Regulatory and Clinical Development stakeholders to ensure strategic alignment and coordinated execution.

• Led complex, cross-functional medical workstreams spanning launch readiness, scientific communications, congress strategy, HEOR/IEP coordination, and external engagement strategy for new product launches, indication expansions, and lifecycle management.

• Establish a clear operating rhythm to facilitate strategic planning, budgeting, and business reviews and align with enterprise and global strategic planning efforts.

• Serve as trusted advisor to VP and US Medical Affairs Leadership by synthesizing complex clinical, scientific and market insights into actional recommendations to enable timely decision making, prioritization, planning, and resourcing of US Medical Affairs priorities.

Medical Governance & Compliance and Organizational Enablement

• Evolve US Medical Affairs governance frameworks, including Medical Review Committees (MRC), and US Medical Asset Teams (US MATs) & assess how to effectively coordinate acros various enterprise forums (as needed) as the portfolio grows.

• Partner with Regulatory and Compliance to ensure compliance with US regulatory standards (FDA, GVP, PhRMA Code), internal policies, and legal requirements.

• Establish and maintain SOPs, training, and internal education to build operational excellence and capabilities across Medical Affairs.

• Serve as a Medical Affairs representative for inspection readiness and audit support, providing training, documentation, and cross-functional coordination.

US Region representation & leadership across Medical Operations Excellence

• Build strong relationships with Global Medical Affairs Operational Excellence and partner with US Medical Field Operations Manager to synergize efforts and evolve grant and funding, congress, ad board and publications planning and execution to meet US Region needs.

Systems, Tools, and Digital Enablement

• Champion continuous innovation in US Medical Affairs operations, advance new ways of working including AI-enabled insights and data-drive planning to drive simplification, scalability and improved decision Medical Affairs processes.

• Collaborate on implementation and governance of digital platforms for insights management, medical planning, and content review.

Required Skills, Experience and Education:

• Bachelor’s (BS) degree required; advanced degree (MS, MBA, PharmD, PhD) or PMP certification strongly preferred.

• 15+ years of experience in biotechnology or pharmaceutical industry (with BS), 13+ years (with MS) or 11+ years (with PharmD/PhD), including 8+ years in Medical Affairs or biotechnology project or program management roles.

• Experience working in the Medical Affairs function, including scientific communications, external engagement, medical congresses, medical compliance, and data dissemination.

• Experience creating strong partnerships across Medical, Commercial, Regulatory and G&A functions.

• Proven track record of leading large, cross-functional initiatives with significant visibility and complexity and building for launch readiness.

• Excellent communication, interpersonal, and presentation skills to engage internal and external stakeholders effectively.

• Strong financial acumen, strategic thinking, and ability to manage ambiguity in a fast-paced environment.

• Strong project management skills to oversee multiple priorities, timelines, and stakeholders effectively.

Preferred Skills:

• Oncology and/or precision medicine experience strongly preferred.

• Previous leadership of Medical Governance frameworks or Medical Review Committees.

• Experience scaling Medical Affairs operations during rapid growth or product launch phases.

• Familiarity with digital tools and innovative solutions for medical insights and communications. 

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