Director, Medical Affairs – Emerging Therapies

🔥 0 minutes ago

🐊 Florida – Remote

🐊 Florida – Remote

⏰ Full Time

🔴 Lead

👨‍⚕️ Medical Director

👻 Ghost score 10%

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INSIGHTEC

WebsiteLinkedInAll Job Openings

201 - 500 employees

🏭 Manufacturing

🏥 Healthcare

💊 Pharmaceuticals

💰 $100M Debt Financing on 2022-08

Manufacturing • Healthcare • Pharmaceuticals

INSIGHTEC is a company pioneering the use of incisionless focused ultrasound technology to treat neurological disorders such as Essential Tremor and Tremor-Dominant Parkinson’s Disease. Their Exablate Neuro platform allows for precision treatment that is incision-free, guided by MRI and offers real-time safety monitoring, often with immediate results and minimal risks. By targeting specific areas of the brain with acoustic energy, they provide a non-invasive alternative to traditional neurosurgery, promoting life-changing transformations for patients all over the world. INSIGHTEC is committed to advancing healthcare innovation and improving patient care through this transformative technology.

📋 Description

• Develop and lead the medical strategy for emerging therapies utilizing the 220KHz FUS platform • Provide medical leadership for early-phase and translational programs • Collaborate with R&D and Strategic Marketing on current and future product portfolios and medical development pathways • Monitor therapeutic trends, competitive landscapes, and scientific advances • Manage clinical trial design, readiness, execution, KOL selection, pre-clinical evidence, and investigator-initiated research • Identify, recruit, and manage KOLs and scientific team members • Align clinical trial timelines and endpoints with commercial and go-to-market plans • Support patient enrollment, patient journeys, budget utilization, and data generation • Oversee publications strategy, data dissemination, and podium presence • Develop and execute global commercial readiness and reimbursement strategies • Convene advisory boards and validate clinical directions and decisions • Lead cross-functional project execution and align medical strategy with development and lifecycle plans • Support go/no-go decisions, portfolio prioritization, and management approvals • Build and maintain relationships with KOLs, investigators, and academic partners • Represent the organization at major congresses and symposia • Provide medical input for regulatory submissions and labeling • Support risk management and safety communications • Mentor and support development of a high-performing medical and clinical support team • Support corporate strategic planning, pipeline development, global expansion, lifecycle decisions, launch readiness, post-marketing research, publications, and lifecycle optimization

🎯 Requirements

• Leadership responsibility for scientific and clinical development of novel and pipeline therapies • Experience advancing early- and mid-stage therapeutic programs • Ability to develop and lead medical strategy utilizing the 220KHz FUS platform • Medical leadership for early-phase and translational programs • Experience collaborating with R&D, strategic marketing, Clinical Affairs, regulatory, market access, commercial, PMO, CMO, and other cross-functional teams • Experience designing, preparing, and executing clinical trials • KOL and scientific opinion leader engagement and management • Experience with evidence generation, publications strategy, data dissemination, and congresses • Experience developing commercial readiness, reimbursement, and market access strategies • Experience convening and leading advisory boards • Ability to provide medical input for regulatory submissions and labeling • Knowledge of risk management and safety communications • Experience building, mentoring, and supporting high-performing medical and clinical teams • Experience with portfolio, lifecycle management, pipeline development, global expansion, and launch readiness

🏖️ Benefits

• Flexible work environment • Life-work balance philosophy • Competitive perks and benefits by region • Opportunities for internal career growth and professional development