DescriptionPosition SummaryThe director of medical affairs, Emerging Therapies, is a leadership role responsible for advancing the scientific and clinical development of novel and pipeline therapies. This position provides strategic clinical innovation leadership across early- and mid-stage therapeutic programs, ensuring scientific rigor, clinical relevance, strategic alignment, as well as ensuring regulatory, market access and commercial readiness.
The role bridges clinical development, strategic planning, market adoption, and utilization by guiding, developing and managing the clinical strategy, engagement with clinical KOL's and scientific opinion leaders, evidence generation, and leadership of external and internal program resources to support and drive a timely development and commercialization of innovative therapeutic solutions.
Key ResponsibilitiesMedical Innovations Strategy- Develop and lead the medical strategy for emerging therapies utilizing the 220KHz FUS platform.
- Provide medical leadership and guidance for early-phase and translational programs.
- Collaborate with R&D and strategic marketing to develop current and future product portfolio with focus on medical development pathways.
- Monitor therapeutic trends, competitive landscapes, and scientific advances. Collaborate with Insightec Strategic Marketing to develop and manage strategic plans and competitive landscape analysis.
Clinical Development & Evidence Generation- Collaborate with Clinical Affairs to manage the design, readiness and execution of clinical trials, KOL selection, pre-clinical evidence as needed, and investigator-initiated research in the respective field.
- Collaborate with CMO and business team to identify, recruit and manage KOL's and scientific team members.
- Ensure alignment of clinical trials timeline and appropriate endpoints definition with commercial and GTM plans. Support trial execution including patient enrollment and journey, budget utilization, and data generation as needed.
- Oversee publications strategy, data dissemination, generation, and podium presence.
- Collaborate with market access team to develop and execute global commercial readiness and reimbursement strategy
- Convene advisory boards to develop and validate clinical directions and decisions. Collaborate with R&D, RA, CA and CMO to ensure availability and inclusion of respective teams in the plans.
Cross-Functional Leadership- Partner with R&D,CA, Regulatory, CMO office, Market Access, Commercial, and Lotus team to drive timely and effective projects execution.
- Collaborate with PMO to align medical strategy and timeline with development and lifecycle management plans.
- Support go/no-go decisions and portfolio prioritization.
- Present to management as needed to obtain proper approvals and buy in.
External Academic Engagement- Build and maintain relationships with key opinion leaders, clinical and scientific investigators, and manage academic partners supporting development efforts.
- Lead advisory boards. Identify and develop clinical pathways and drive consensus
- Manage and represent the organization at major congresses and symposia including management of publications strategy and timeline.
Regulatory, Ethics & Compliance- Provide medical input for regulatory submissions and labeling.
- Support risk management and safety communications.
Team Leadership & Capability Building- Cross functional effort to guide mentor and support the development of a high performing medical and clinical support team.
- Foster a culture of medical excellence, innovation and cross functional collaboration.
Portfolio & Lifecycle Management- Support corporate strategic planning, pipeline development global expansion and lifecycle decisions. Lead and manage the medical scientific chapter.
- Plan and support launch readiness for first-in-class and best-in-class therapies.
- Support post-marketing research, publications and lifecycle optimization.
Key Performance Indicators (KPIs)- Scientific and medical KOL Engagement management and alignment
- Timely, results oriented clinical trial execution, data generation and market access
- Quality and impact of evidence generation
- Team leadership, performance management, development and retention.
- Cross-Functional collaboration, alignment, commercial readiness and transition
- Recognized by his peers as the go-to person for his responsibilities
