Job Title: Executive Director, Neurology Clinical Development
Location: Flexible (Remote, Hybrid, or Onsite in Southern California)
Company Description:
Meet is partnering up with a leading biotechnology company at the forefront of genetic medicine, dedicated to transforming the treatment landscape for patients with rare and neurologic diseases.
Position Overview:
This position is instrumental in shaping and executing development strategies for our neurology portfolio, focusing on neuromuscular diseases .
Key Responsibilities:
- Lead and oversee multiple Clinical Project Teams, driving the design and implementation of Development Plans for Phase 3 programs neurology.
- Play a key role in building and leading a team to advance a neuromuscular disease asset, leveraging the leading-edge technology in this therapeutic area.
- Collaborate with external medical/scientific advisors, thought leaders, and clinical investigators, while engaging closely with internal stakeholders across Research, Development, and Commercial teams.
- Contribute to Integrated Development Plans, ensuring alignment with strategic vision and regulatory requirements. Proactively address clinical development pathway gaps such as biomarker and natural history study needs.
- Engage with regulatory agencies to design and develop efficient clinical programs, leveraging novel trial designs and regulatory mechanisms.
Requirements:
- MD with approximately 5 years of industry experience, demonstrating strong leadership in clinical development across early- to late-stage therapeutic programs.
- Proven track record in rare neurologic and/or neuromuscular diseases preferred, with experience in leading clinical development efforts in both large and small biopharmaceutical companies.
- Expertise in clinical trial design, including adaptive designs, and comprehensive understanding of preclinical and clinical development processes.
- Successful history of developing, planning, and executing clinical studies leading to therapeutic registrations.
- Experience with regulatory submissions and interactions, including novel trial designs and indications.
