Medical Director, MDS

🕒 February 26

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Asklepios BioPharmaceutical, Inc. (AskBio)

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 2001

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Biotechnology • Pharmaceuticals • Healthcare Insurance

Asklepios BioPharmaceutical, Inc. (AskBio) is a leading gene therapy company focused on developing treatments for debilitating genetic diseases. Wholly owned by Bayer AG, AskBio specializes in adeno-associated virus (AAV)-based gene therapies aimed at treating various neuromuscular, central nervous system, cardiovascular, and metabolic diseases. One of their notable developments is AB-1003 (LION-101), which has received FDA rare pediatric disease and orphan-drug designations for treating limb-girdle muscular dystrophy type 2I/R9. AskBio is dedicated to advancing genetic medicine, with a robust portfolio of clinical programs designed to bring innovative therapeutic options to patients worldwide.

📋 Description

• 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

🎯 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.

🏖️ Benefits

• Health insurance • 401(k) matching • Flexible work hours • Paid time off • Professional development opportunities