Medical Director, MDS

Position Summary

The Medical Director, Movement Disorders Specialist, GDNF Program provides strategic and hands‑on clinical leadership for gene therapy programs targeting CNS movement disorders across Phase1‑3 development. This role has study‑level accountability for clinical strategy, benefit‑risk assessment, and execution, and serves as a medical leader within the organization.

• Drive the overall clinical development strategy in alignment with function, program team, and timelines for the GDNF gene therapy program across Phase1–3 with a specific focus on movement disorders.
• Serve as a Parkinson’s clinical expert in state‑of‑the‑art, randomized, double‑blind clinical trials with emphasis on maintaining the blinding status of the trial.
• Serve as the medical lead for clinical trial design, protocol development, and endpoint strategy for movement disorders indications.
• Provide medical oversight for clinical trials, ensuring patient safety, data integrity, and regulatory compliance.
• Lead clinical risk‑benefit assessments, including safety signal evaluation, dose‑escalation decisions, and go/no‑go recommendations.
• Authoring support for regulatory interactions, including FDA meetings, briefing documents, and inspection readiness activities.
• Oversee long‑term follow‑up (LTFU) strategies required for gene therapy products, including delayed safety monitoring and post‑treatment commitments.
• Guide and mentor Medical Directors and other clinical team members; contribute to clinical capability building.
• Partner with Clinical Operations, Biostatistics, Regulatory, and CMC to ensure integrated program execution.
• Present clinical strategy and data to senior leadership, governance committees, and external stakeholders.
• Ensure a culture of inspection readiness, quality, and continuous improvement across the clinical organization.
• Support the strategic vision for clinical development for the GDNF program and contribute to broader organizational clinical strategy as appropriate.
• Foster and maintain strong relationships with key opinion leaders (KOLs), investigators, and external scientific and clinical stakeholders.
• Oversee the integration of clinical development activities with cross‑functional partners, including Regulatory, CMC/Manufacturing, Commercial, and Research, to ensure seamless program advancement.
• Represent the organization as a clinical and scientific leader in high‑level industry forums, scientific meetings, advisory boards, and conferences.

• MD from an accredited U.S. medical school or equivalent international medical degree with 6+ years relevant clinical experience with Movement Disorders patients.
• Completion of clinical training with board certification or eligibility in Neurology or a closely related specialty with movement disorders specialization and clinical experience.
• Minimum of two years of industry experience or related experience in clinical development within the pharmaceutical, biotechnology, medical device, or CRO/CDMO environment.
• Demonstrated leadership in the design and execution of clinical trials across multiple phases, including oversight of clinical monitoring activities.
• Proven experience supporting FDA or global health authority inspections, audits, or formal inspection readiness initiatives.
• Working knowledge of GCP, regulatory requirements, and trial quality management systems.
• Ability to independently lead clinical programs and make program‑level medical decisions in a regulated development environment.
• Strong strategic leadership and cross‑functional influence.
• Ability to support FDA inspection readiness activities, including review of critical trial documentation, monitoring outputs, and CAPAs.
• Expertise in risk‑based monitoring and clinical trial quality oversight.
• Strong analytical judgment applied to complex clinical and safety issues.
• Excellent communication and executive presentation skills.
• Ability to operate effectively in a fast‑paced, evolving biotech environment.
• Proven track record of successful clinical program leadership, including advancing programs through critical development milestones.
• Exceptional strategic and operational planning…