Medical Director, MDS

Position Summary

The Medical Director, Movement Disorders Specialist, GDNF Program will provide strategic and hands-on clinical leadership for gene therapy programs targeting CNS movement disorders across Phase 1–3 development. This role has study-level accountability for clinical strategy, benefit-risk assessment, and execution, and serves as a medical leader within the organization.

Job Responsibilities

• Drive the overall clinical development strategy in alignment with function, program team and timelines for the GDNF gene therapy program across Phase 1–3 with 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 maintenance of the blinding status of the trial
• 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
• 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

Minimum Requirements

• 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 skills, with the ability to translate long-term vision into executable clinical plans
• Strong leadership presence with the ability to influence, inspire, and align cross-functional teams
• Established professional network within the gene therapy and/or CNS development community
• Understanding of market dynamics, competitive landscape, and evolving trends relevant to gene therapy and movement disorders

Preferred Education, Experience And Skills

• Prior experience in CNS, neurology, or movement disorders clinical development
• Experience leading or significantly contributing to Phase 1+2 and Phase 3 registrational trials for Parkinson’s disease or similar disorders
• Experience in gene therapy, cell therapy, or advanced therapeutic modalities, including long-term safety considerations
• Direct experience overseeing long-term follow-up (LTFU) studies for gene therapy products
• Experience working in rare disease or small patient population settings
• Experience mentoring Medical Directors & clinical staff with non-neurology background