Associate Director/Director of Clinical Development - GQR : Job Details

Job Title: AD/Director of Clinical Development

Location: South San Francisco (Hybrid: 3 days onsite)

Reporting To: VP of Clinical Development

Overview: The AD/Director of Clinical Development will oversee the execution of clinical studies within our portfolio, ensuring high-quality and timely delivery. In this role, you will act as a Medical Monitor and collaborate closely with clinical operations and CROs.

Key Responsibilities:

• Contribute to the design and development of clinical study protocols for Phases 1 to 3.
• Ensure compliance with Good Clinical Practice (GCP), company standard operating procedures (SOPs), and applicable laws and regulations. Address outstanding clinical or GCP issues and provide medical expertise to the study team during critical activities.
• Serve as the Sponsor's Medical Monitor, ensuring clinical studies are conducted in accordance with the protocol.

Qualifications:

• M.D. degree with a minimum of 3-5 years of experience in clinical research and development within the pharmaceutical or biotech industry.
• Proven experience in clinical development from Phases 1 to 3, including first-in-human and pivotal studies.
• Familiarity with rare diseases and fibrotic diseases affecting the liver (e.g., PSC, PBC, NASH) and/or lung (e.g., IPF, ILD, cystic fibrosis) is preferred.
• Experience in developing clinical study documents such as clinical trial protocols, Investigator's Brochures, and clinical study reports.

Applications without resumes attached will not be considered.

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