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Medical Director, MDS

External
askbio logoAskbio · Remote
Full-timeRemote3w ago
Clinical TrialsComplianceLeadership
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AskBio Inc., a wholly owned and independently operated subsidiary of Bayer AG, is a fully integrated gene therapy company dedicated to developing life-saving medicines and changing lives. The company maintains a portfolio of clinical programs across a range of neuromuscular, central nervous system, cardiovascular, and metabolic disease indications with a clinical-stage pipeline that includes investigational therapeutics for congestive heart failure, limb-girdle muscular dystrophy, multiple system atrophy, Parkinson's disease, and Pompe disease. AskBio's gene therapy platform includes Pro10™, an industry-leading proprietary cell line manufacturing process, and an extensive array of capsids and promoters. With global headquarters in Research Triangle Park, North Carolina, and European headquarters in Edinburgh, Scotland, the company has generated hundreds of proprietary capsids and promoters, several of which have entered pre-clinical and clinical testing. Our vision: Pioneering science to create transformative molecular medicines. Our mission: Lead innovative science and drive clinical outcomes to transform people's lives. Our principles: Advance innovative science by pushing boundaries. Bring transformative therapeutics to patients in need. Provide an environment for employees to reach their fullest potential. Our values: Be a Pioneer. We are not afraid of the impossible and to innovate to make gene therapies accessible to those in need. Cultivate Collaboration. Strive to be the best teammate, actively listen, openly communicate, and embrace diverse points of view. Embrace Responsibility. We are humbled by the enormity of our mission. We hold a relentless commitment to advance science and clinical outcomes for our patients, families, and caregivers. Raise the Bar. Continuously drive improvements and efficiencies. Seek and provide constructive feedback. Have a bias for learning and action. Act with Uncompromising Integrity. Be honest, transparent, and committed to doing what's right in every situation. Make clear commitments and follow through. 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. The Movement Disorders Specialist Medical Director will guide cross-functional teams, support regulatory interactions, and ensure inspection-ready, high-quality clinical development from first-in-human studies through registrational trials and long-term follow-up. 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 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 Minimum Requirements MD from an accredited U.S. medical school or equivalent international medical degree with 6+ years relevant clin


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