Director, Medical Affairs – Emerging Therapies

Job description

**This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Director, Medical Affairs – Emerging Therapies based in the United States.** The Director, Medical Affairs – Emerging Therapies will shape the scientific and clinical development of innovative therapies, driving progress from early-stage research through commercialization. This strategic leadership role focuses on advancing emerging treatments using a 220 kHz focused ultrasound platform, translating scientific innovation into clinically relevant solutions. You will guide evidence generation, clinical development strategies, and engagement with leading clinicians, researchers, and scientific experts. Working closely with research and development, regulatory, clinical, commercial, and market access teams, you will help align therapeutic innovation with patient needs and market opportunities. You will also influence portfolio planning, launch readiness, and long-term product lifecycle decisions. This is an opportunity to make a meaningful contribution to the future of healthcare within a collaborative, international, and innovation-driven environment. ### Accountabilities: In this role, you will provide strategic medical leadership across emerging therapeutic programs, ensuring scientific excellence, effective clinical development, and alignment between innovation, regulatory requirements, and commercial objectives. Your main responsibilities will include: - **Medical strategy and innovation:** Develop and lead medical strategies for emerging therapies utilizing the 220 kHz focused ultrasound platform, providing clinical guidance for early-stage and translational programs. - **Portfolio development:** Collaborate with Research and Development and Strategic Marketing to shape current and future product portfolios, assess therapeutic opportunities, and define medical development pathways. - **Scientific and competitive intelligence:** Monitor emerging scientific evidence, therapeutic trends, and competitive landscapes to inform strategic planning and identify opportunities for innovation. - **Clinical development and evidence generation:** Partner with Clinical Affairs to support clinical trial design, readiness, and execution, including investigator-initiated research, preclinical evidence generation when needed, and the selection of appropriate clinical investigators. - **Clinical trial oversight:** Align trial timelines and endpoints with commercial and go-to-market plans while supporting patient enrollment, patient journey considerations, budget utilization, and data generation. - **Key opinion leader engagement:** Identify, recruit, and maintain relationships with key opinion leaders, scientific experts, investigators, academic partners, and other external stakeholders. - **Publications and scientific communications:** Oversee publication strategies, evidence dissemination, scientific presentations, and participation in major congresses and symposia. - **Market access and reimbursement:** Collaborate with Market Access and commercial teams to develop global commercialization readiness and reimbursement strategies. - **Advisory boards and clinical pathways:** Organize and lead advisory boards, validate clinical directions, build consensus around treatment pathways, and coordinate input from relevant internal and external experts. - **Cross-functional leadership:** Work closely with Research and Development, Clinical Affairs, Regulatory Affairs, the Chief Medical Officer’s office, Market Access, Commercial, and other relevant teams to ensure coordinated execution. - **Program planning and prioritization:** Partner with the Project Management Office to align medical strategies and timelines with development plans and product lifecycle management. Contribute to go/no-go decisions and portfolio prioritization. - **Executive communication:** Present medical strategies, program updates, and recommendations to management to secure alignment, approvals, and necessary resources. - **Regulatory, ethics, and safety:** Provide medical input for regulatory submissions and product labeling, and support risk management and safety communications. - **Team leadership and development:** Mentor and support a high-performing medical and clinical team, strengthening capabilities, performance, collaboration, and professional development. - **Lifecycle management and launch readiness:** Contribute to corporate strategy, pipeline development, global expansion, launch planning for first-in-class and best-in-class therapies, post-market research, and lifecycle optimization. - **Performance management:** Monitor progress across scientific engagement, clinical execution, evidence quality, market access, commercial readiness, team performance, and cross-functional collaboration. **Requirements:** The ideal candidate will bring strong medical and scientific leadership, a strategic understanding of clinical development, and the ability to coordinate complex programs across multiple functions and external stakeholders. The position calls for: - 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 the progression of therapies toward commercialization. - Experience developing medical strategies and translating scientific findings into clinical development plans and broader portfolio priorities. - Proven ability to collaborate with Research and Development, Clinical Affairs, Regulatory Affairs, Market Access, Commercial, and other cross-functional teams. - Experience building and managing relationships with key opinion leaders, clinical investigators, scientific experts, academic partners, and advisory boards. - Knowledge of clinical evidence dissemination, publication planning, scientific congresses, and medical communications. - Understanding of regulatory submissions, product labeling, safety communications, and risk management considerations. - Familiarity with market access, reimbursement strategy, go-to-market planning, and launch readiness for innovative therapies. - Ability to assess competitive landscapes, evaluate therapeutic opportunities, and contribute to portfolio prioritization and lifecycle decisions. - Strong leadership and people-development skills, including mentoring, performance management, and fostering a culture of medical excellence. - Excellent strategic thinking, analytical skills, and judgment, with the ability to balance scientific rigor, clinical relevance, business priorities, and patient needs. - Strong written, verbal, and presentation skills, including the ability to communicate complex medical and scientific concepts to executives and diverse stakeholders. - Demonstrated ability to manage multiple programs, coordinate resources, and deliver results within complex, cross-functional environments. **Benefits:** The role offers an opportunity to contribute to the development of innovative therapies within a flexible, collaborative, and internationally connected work environment. - **Remote work:** US-based remote position. - **Flexible work environment:** A culture that supports work-life balance and encourages employees to pursue meaningful interests outside work. - **Professional development:** Opportunities to grow internally, expand expertise, and pursue long-term career ambitions. - **Collaborative culture:** Work alongside multidisciplinary colleagues across clinical, scientific, regulatory, commercial, and technical functions. - **Meaningful impact:** Contribute to healthcare innovation and the development of therapies designed to improve patients’ lives. - **Competitive regional benefits:** The organization offers region-specific perks and benefits; detailed US benefit provisions and salary information were not specified in the job description.