Executive Director, Scientific & Medical Excellence

Responsibilities

• Evidence Generation Planning
• Lead the development of the integrated evidence generation plan, in partnership with HEOR, aligned to overarching medical and asset strategy and informed by clearly prioritized scientific and stakeholder evidence gaps.
• Coordinate the planning of real-world evidence (RWE), registries, natural history studies, database analyses, and Phase 4 / post-marketing studies in partnership with Clinical Development, HEOR, and Biostatistics.
• Ensure evidence plans support regulatory interactions, value demonstration, payer engagement, and HTA requirements, and that data are disseminated through a coordinated publication strategy.
• Investigator-Sponsored Trials (IST) & Sponsored Research
• Own the strategy, governance, and end-to-end operations of the investigator-sponsored trial (IST) program, including the review committee, scientific prioritization, and funding decisions aligned to medical strategy and evidence gaps.
• Develop and manage sponsored research collaborations and external research partnerships with academic centers, consortia, and cooperative groups.
• Establish transparent processes for proposal intake, contracting, milestone tracking, publication expectations, and compliant oversight of supported research.
• Partner with Legal, Compliance, Finance, and Regulatory to ensure all externally sponsored research meets internal standards and applicable regulations.
• Medical Information
• In partnership with the Bridge Bio MI Lead, manage affiliate Medical Information function, including strategy, content, and operations for responding to unsolicited requests from healthcare professionals, patients, and other stakeholders.
• Oversee development and scientific governance of standard response documents, FAQs, and the medical information content library, ensuring accuracy, balance, and compliance.
• Manage call center / vendor operations, escalation pathways, and service-level standards for medical inquiry handling.
• Expanded Access / Compassionate Use Programs
• Develop, implement, and manage expanded access / compassionate use (early access, named-patient, and managed access) programs in alignment with medical, regulatory, and ethical standards.
• Establish governance, eligibility criteria, request-handling workflows, and supply coordination, balancing patient need with program integrity and compliance.
• Partner with Regulatory, Clinical, Supply Chain, Legal, and Patient Advocacy across regions to ensure consistent, equitable, and compliant access processes.
• Technology & Innovation in Medical Affairs
• Define and drive the Medical Affairs AI strategy—identifying, piloting, and scaling AI and advanced analytics use cases across medical information, evidence synthesis, content generation, insights, and operations.
• Partner with Data Science, IT, Legal, and Compliance to establish responsible-use, governance, validation, and data-privacy guardrails for AI tools in a regulated environment.
• Champion change management and capability building so teams adopt new tools effectively, with measurable impact on quality, speed, and decision-making.
• Global Medical Planning & Alignment
• Drive global medical planning and alignment, harmonizing strategy, standards, and ways of working across affiliates, regions, and partners.
• Build the operating model, governance forums, and shared tools/metrics that ensure consistency while enabling regional execution.
• Serve as a connective leader across Medical Affairs sub-functions and cross-functional partners to ensure coordinated, on-strategy delivery.

Qualifications

• MD, DO, PharmD, PhD, or equivalent advanced scientific or clinical degree.
• 12+ years of experience in Medical Affairs, including leadership roles, within the biopharmaceutical industry and/or academic medicine.
• Demonstrated, hands-on leadership experience across several of the core areas of this role: Medical Information, investigator-sponsored / sponsored research programs, evidence generation planning, and expanded access / compassionate use programs.
• Experience driving AI, digital, or advanced-analytics initiatives within Medical Affairs strongly preferred.
• Experience leading global or multi-region medical planning and alignment in a matrixed organization.
• Demonstrated experience in rare disease strongly preferred.
• Strong understanding of regulatory and compliance requirements related to medical information, externally sponsored research, expanded access, and post-marketing activities.
• Strategic thinker with strong execution capabilities and a track record of building scalable processes, governance, and teams.
• Excellent written and verbal communication skills, including experience presenting to senior leadership and external stakeholders.
• High degree of scientific rigor, integrity, and patient-centered focus.