Director, Medical Affairs – Emerging Therapies

Insightec•Miami, FL

About The Position

The Director of Medical Affairs, Emerging Therapies, is a leadership role responsible for advancing the scientific and clinical development of novel and pipeline therapies. The position provides strategic clinical innovation leadership across early- and mid-stage therapeutic programs, ensuring scientific rigor, clinical relevance, strategic alignment, and regulatory, market access, and commercial readiness. The role bridges clinical development, strategic planning, market adoption, and utilization. It guides and manages clinical strategy, engagement with clinical key opinion leaders and scientific opinion leaders, evidence generation, and internal and external program resources to support timely development and commercialization of innovative therapeutic solutions. The role develops medical strategy for emerging therapies using the 220KHz FUS platform; provides medical leadership for early-phase and translational programs; and works across clinical affairs, R&D, strategic marketing, regulatory, market access, commercial, and other teams. It supports clinical trials and evidence generation, external academic engagement, regulatory and safety activities, portfolio planning, launch readiness, and post-marketing research. It also leads and develops medical and clinical support capabilities.

Responsibilities

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 the current and future product portfolio, focusing on medical development pathways.
Monitor therapeutic trends, competitive landscapes, and scientific advances; collaborate with Strategic Marketing on strategic plans and competitive landscape analysis.
Collaborate with Clinical Affairs on the design, readiness, and execution of clinical trials, KOL selection, pre-clinical evidence as needed, and investigator-initiated research.
Collaborate with the CMO and business team to identify, recruit, and manage KOLs and scientific team members.
Align clinical trial timelines and endpoint definitions with commercial and go-to-market plans; support trial execution, including patient enrollment and journey, budget utilization, and data generation as needed.
Oversee publications strategy, data dissemination and generation, and podium presence.
Collaborate with Market Access to develop and execute global commercial readiness and reimbursement strategy.
Convene and lead advisory boards to develop and validate clinical directions and decisions; coordinate with R&D, Regulatory Affairs, Clinical Affairs, and the CMO office to involve relevant teams.
Partner with R&D, Clinical Affairs, Regulatory, the CMO office, Market Access, Commercial, and the Lotus team to drive timely, effective project execution.
Collaborate with PMO to align medical strategy and timelines with development and lifecycle management plans.
Support go/no-go decisions and portfolio prioritization; present to management as needed to obtain approvals and buy-in.
Build and maintain relationships with KOLs, clinical and scientific investigators, and academic partners supporting development efforts.
Identify and develop clinical pathways and drive consensus.
Represent the organization at major congresses and symposia, including managing publication strategy and timelines.
Provide medical input for regulatory submissions and labeling; support risk management and safety communications.
Guide, mentor, and support development of a high-performing medical and clinical support team; foster medical excellence, innovation, and cross-functional collaboration.
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.