Executive Director, Clinical Development

BioTalent Ltd; Georgia; Remote; USD 150,000 - 250,000; Full time

Job summary

A leading company in the biopharmaceutical sector is seeking an Executive Director for Clinical Development to spearhead gene therapy programs. This remote position involves strategic leadership in clinical trials and regulatory submissions, requiring an M.D. with extensive experience in the field. The ideal candidate will excel in collaboration and possess a strong background in neurology or gene therapy.

Qualifications

• M.D. required; neurology and/or gene therapy background strongly preferred.
• Minimum 5 years of clinical development experience in the biopharmaceutical industry.
• Hands-on regulatory experience and familiarity with global health authority requirements.

Responsibilities

• Drive clinical development strategies for programs and represent the function in governance discussions.
• Lead design and oversight of Phase 1/2 trials, including protocol development and vendor management.
• Develop clinical sections of global regulatory submissions and represent the clinical function in health authority interactions.

Skills

Communication

Organization

Collaboration

Education

M.D.

Job description

Executive Director, Clinical Development
Remote – United States

Seeking an Executive Director, Clinical Development to join a growing team focused on advancing gene therapy programs in critical disease areas, particularly within the central nervous system. This role offers the opportunity to lead strategic and operational aspects of clinical development across early-phase trials, including regulatory interactions and cross-functional collaboration.

Key Responsibilities

• Drive clinical development strategies for one or more programs and represent the function in governance and partner discussions.
• Lead design and oversight of Phase 1/2 trials, including protocol development, endpoint definition, site selection, and vendor management.
• Act as medical monitor, oversee patient safety, and partner with data functions on statistical analysis and reporting.
• Develop clinical sections of global regulatory submissions (e.g., INDs, CTAs) and represent the clinical function in health authority interactions.
• Work closely with internal teams and engage external stakeholders including investigators, KOLs, and advocacy groups. Represent the company at scientific and medical forums.

Qualifications

• M.D. required; neurology and/or gene therapy background strongly preferred.
• Minimum 5 years of clinical development experience in the biopharmaceutical industry.
• Demonstrated success in early-phase trial design and execution.
• Hands-on regulatory experience and familiarity with global health authority requirements.
• Strong grasp of regulatory guidelines (ICH-GCP, FDA, EMA).
• Deep understanding of biologics; gene therapy knowledge a plus.
• Excellent communication, organization, and collaboration skills.
• Comfortable in fast-paced, matrixed environments.