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Medical Director

Menlo Park, CA 94025

Posted: 03/03/2025 Employment Type: Direct Hire Job Category: Medical Affairs Job Number: 4283

Job Description

The Medical Director will lead all aspects of our client's gene therapy clinical program. This individual will be a senior clinical physician responsible for overseeing the medical aspects of developing an AAV-based gene therapy treatment, including clinical trial strategy and design, execution, safety monitoring, data analysis and interpretation, clinical site interactions, and regulatory submissions. This individual will be the primary medical expert on the XXXX gene therapy clinical trial and ensure the highest standards of patient care throughout the clinical development process.

Key Responsibilities:
Clinical Leadership & Strategy:
  • Provide strategic clinical leadership for the gene therapy program
  • Lead the strategic development of clinical trial designs and the development of clinical protocol amendments, investigator brochures, informed consent forms, and other study documents for AAV gene therapy trials.
  • Monitor patient recruitment, data collection, and safety reporting throughout the trial.
  • Conduct data analysis and interpretation, including assessment of efficacy and safety endpoints.
 Regulatory Interactions:
  • Collaborate with regulatory science to prepare and author regulatory filings and briefing packages.
  • Act as the primary clinical expert for all global regulatory interactions.
  • Provide medical expertise to address regulatory inquiries and concerns regarding AAV gene therapy development.

 Medical Expertise and Scientific Leadership:
  • Stay abreast of the latest advancements in AAV gene therapy, including preclinical research, clinical trial methodologies, and emerging safety concerns. 
  • Lead scientific discussions with clinical investigators, key opinion leaders, internal stakeholders, and external collaborators.
  • Contribute to the development of medical affairs strategy, including publications and presentations.
Cross-Functional Collaboration:
  • Work closely with Clinical Operations, Biostatistics, Translational Science, Regulatory Science, Quality Assurance, and Manufacturing to ensure smooth execution of clinical trials and regulatory filings.
  • Advises executives on medical-related decisions to align business strategies with best clinical practice.
Required Qualifications:
  • Advanced medical degree (MD or equivalent) with a strong understanding of clinical research methodologies.
  • Expertise in the field of AAV gene therapy with relevant rare disease experience.
  • Proven experience in clinical trial design and execution, including leadership roles in Phase 1, 2, and 3 studies.
  • Excellent communication, presentation, and interpersonal skills to effectively collaborate with cross-functional teams and external partners.
  • Familiarity with regulatory requirements for clinical trials and drug development.
 Preferred Attributes:
  • Strong work ethic / dedication, sense of urgency, ability to thrive in a fast-paced environment.
  • Experience in start-ups or small companies, showcasing adaptability and a “roll-up-your-sleeves” mentality.
  • Proven ability to balance strategic vision with operational execution, managing competing priorities effectively.
  • Strong communication and interpersonal skills with ability to influence stakeholders across all levels.
  • Flexible-thinker with a fit-for-purpose, solution-oriented approach, and “can-do” attitude.
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About Menlo Park, CA

Ready to jumpstart your career in the vibrant heart of Menlo Park, California? Nestled in the bustling Silicon Valley, this dynamic region beckons with unparalleled growth opportunities and a thriving tech-centric environment. Unleash your potential in the epicenter of innovation, where companies like Facebook and Stanford University drive groundbreaking advancements. With the picturesque Stanford University, the iconic Menlo Park Caltrain station, and the bustling downtown area brimming with cafes and boutiques, this locale offers a blend of charm and modernity like no other. Explore career opportunities surrounded by the lush landscapes of nearby parks like Bedwell Bayfront Park or catch a game at the Stanford Stadium. Join us in discovering the endless possibilities that await in Menlo Park and unlock your career aspirations today!