Senior Medical Director, Clinical Science

Job Summary

To support a growing clinical research team, the remote Senior Medical Director, Clinical Science will oversee clinical trial execution, lead regulatory filing preparations, and provide clinical expertise for research and development projects in the rare disease sector.

Key responsibilities

• Lead preparation of clinical sections for regulatory filings, with a focus on BLA filing experience
• Strategically plan and execute clinical trials while serving as the Medical Monitor
• Collaborate with internal stakeholders and external investigators to ensure effective project management and implementation of clinical guidelines

Required qualifications

• MD, MD/PhD, or PhD
• Minimum of 5 years relevant experience in the pharmaceutical or biotech industry
• Proven track record in regulatory filing and knowledge of GCP guidelines in the US and Europe
• Experience in rare diseases is desirable
• Strong leadership and communication skills, with the ability to collaborate effectively at all levels