Asklepios BioPharmaceutical, Inc. (AskBio)

The Director, Biostatistics provides technical leadership and operational oversight for developing clinical strategies, designing, implementing, and reporting on non-clinical, CMC, and clinical development programs and associated studies. This role involves guiding statisticians, programmers, and data managers to ensure timely, high-quality deliverables while supporting global regulatory interactions.

The Associate Director will lead the development and implementation of strategic planning for Medical Affairs Operations and Capabilities Excellence, refining medical strategies for optimized global launch readiness and a robust external engagement program. Key duties include leading the Material Review Board process using Veeva, defining system requirements, designing the Medical Insight Generation process, and leading advanced projects.

This role manages and tracks Medical Affairs contracts, invoices, and purchase orders, ensuring compliant processing and timely payments. The specialist also provides operational support for initiatives like congress planning and assists with the Medical Review Board process.

This role involves leading and executing the clinical development strategy for gene therapy programs across Phase 1-3, providing medical and scientific input into trial design, protocol development, and dose escalation strategies, particularly for CNS and movement disorders. The director will oversee all clinical trials, ensure data integrity and patient safety, and collaborate with cross-functional teams and external partners.

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.

Medical Affairs Operations Specialist coordinating Medical Affairs activities at AskBio.

Medical Director leading clinical development for gene therapy programs

This role offers a unique chance to broaden your experience, expand your knowledge, and contribute meaningfully to AskBio’s mission: to advance gene therapy and change the lives of patients around the world. Lead and execute the clinical development strategy for gene therapy prog...

Associate Director leading Medical Affairs Operations for AskBio's gene therapy team

Medical Director overseeing safety evaluation for gene therapy products