Position listed on behalf of a partner company managing applications and next steps.
Partner is looking for a Director, Medical Affairs – Emerging Therapies based in the United States.
Responsibilities
Medical strategy and innovation: develop and lead medical strategies for emerging therapies utilizing the 220 kHz focused ultrasound platform.
Portfolio development: collaborate with R&D and Strategic Marketing to shape product portfolios and define medical development pathways.
Scientific and competitive intelligence: monitor emerging scientific evidence, therapeutic trends, and competitive landscapes.
Clinical development and evidence generation: partner with Clinical Affairs on trial design, readiness, execution, investigator-initiated research, and investigator selection.
Clinical trial oversight: align trial timelines and endpoints with commercial and go-to-market plans.
Key opinion leader engagement: identify, recruit, and maintain relationships with KOLs, scientific experts, investigators, and academic partners.
Publications and scientific communications: oversee publication strategies, evidence dissemination, and congress participation.
Market access and reimbursement: collaborate with Market Access and commercial teams on commercialization readiness and reimbursement strategies.
Advisory boards and clinical pathways: organize and lead advisory boards and build consensus around treatment pathways.
Cross-functional leadership: work with R&D, Clinical Affairs, Regulatory Affairs, CMO’s office, Market Access, and Commercial teams.
Program planning and prioritization: align medical strategies and timelines with development plans and lifecycle management.
Executive communication: present medical strategies and recommendations to management.
Regulatory, ethics, and safety: provide medical input for regulatory submissions, labeling, and safety communications.
Team leadership and development: mentor and support a high-performing medical and clinical team.
Lifecycle management and launch readiness: contribute to corporate strategy, pipeline development, global expansion, and launch planning.
Performance management: monitor progress across scientific engagement, clinical execution, evidence quality, market access, and team performance.
Requirements
Demonstrated experience in medical affairs, clinical development, or a closely related leadership function, ideally involving emerging therapies and innovative medical technologies.
Strong understanding of early-stage and translational clinical development, evidence generation, clinical trial planning, and progression toward commercialization.
Experience developing medical strategies and translating scientific findings into clinical development plans and portfolio priorities.
Proven ability to collaborate with R&D, Clinical Affairs, Regulatory Affairs, Market Access, Commercial, and other cross-functional teams.
Experience building and managing relationships with KOLs, clinical investigators, scientific experts, academic partners, and advisory boards.
Knowledge of clinical and regulatory requirements.