The Director of Regulatory Affairs will lead global regulatory strategy for assigned gene therapy programs and manage interactions with health authorities. They will collaborate with cross-functional teams to ensure high-quality regulatory submissions and compliance throughout the product development lifecycle.
Lead the development and delivery of global Medical Affairs plans and strategies for Neuromuscular programs. This includes managing KOL engagement, publication planning, and collaborating with cross-functional teams to drive clinical outcomes.
Lead the global strategic clinical development for the GDNF program, overseeing the design and execution of complex gene therapy clinical trials. Manage a team of medical directors and collaborate cross-functionally to support regulatory approvals and commercial launches in the US, EU, and UK.
Lead the global strategic clinical development for the GDNF program, overseeing the design and execution of complex gene therapy clinical trials. Manage a team of medical directors and collaborate cross-functionally to ensure successful regulatory approval and commercial launch.
The Medical Director will provide strategic and hands-on clinical leadership for gene therapy programs targeting CNS movement disorders across Phase 1–3 development, holding study-level accountability for clinical strategy and execution. Key duties include serving as a Parkinson’s clinical expert, guiding cross-functional teams, supporting regulatory interactions, and overseeing trial execution from first-in-human through registrational phases.
The Medical Director will provide strategic and hands-on clinical leadership for gene therapy programs targeting CNS movement disorders across Phase 1-3 development, serving as the medical leader for clinical trial design and execution. Key duties include driving clinical development strategy, serving as a Parkinson’s clinical expert, leading risk-benefit assessments, and supporting regulatory interactions.
