Director Clinical Development

$320,000 - $335,000/Yr

Gqr - South San Francisco, CA

Full-time - Senior

South San Francisco, CA

Food Services and Drinking Places

About the position

The Director of Clinical Development will oversee early to late-stage clinical studies across various indications, fostering strong relationships with Principal Investigators and study sites. This role is pivotal in ensuring compliance with clinical protocols and optimizing study conduct, positioning the company as a preferred partner in clinical research.

Responsibilities

• Act as the Sponsor's Medical Monitor in collaboration with clinical operations and CROs, ensuring compliance with clinical study protocols.
• Participate in clinical sub-teams relevant to assigned molecules/indications, supporting cross-functional integration and coordination.
• Ensure clinical studies comply with GCP, company SOPs, and regulations; address outstanding clinical or GCP issues.
• Maintain high standards of scientific and clinical knowledge in assigned therapeutic areas.
• Contribute to the design and development of clinical study protocols from concept to full protocol.
• Collaborate with clinical operations to identify and select CROs and external investigators.
• Oversee protocol training and represent clinical development in Investigator meetings.
• Coordinate with the study team to review and approve study processes and deliverables.
• Lead the development of clinical responses to protocol questions from regulatory authorities and ethical committees.
• Collaborate with clinical teams to monitor study progress and communicate issues and strategies.
• Review patient profiles and study data, including adverse events and protocol deviations.
• Participate in database lock reviews and procedures with clinical operations and CROs.
• Review study data outputs for comprehensive clinical interpretation and develop topline study reports.
• Participate in scientific communication and publication strategies for studies.
• Engage with principal investigators and key opinion leaders at scientific events.
• Collaborate in developing clinical sections of investigator brochures and safety reports.
• Review clinical data for assigned studies and present findings at drug safety reviews.
• Support pharmacovigilance processes and review safety narratives and regulatory reports.

Requirements

• M.D. degree with 3-5 years of clinical research and development experience in the pharmaceutical/biotech industry.
• Clinical development experience in Phases 1 to 4, including first-in-human and pivotal studies.
• Experience with rare diseases, fibrotic diseases, and/or lung diseases is a plus.
• Experience in developing clinical study-related documents such as protocols and clinical study reports.
• Knowledge of clinical trial methodology, statistics, and regulatory compliance requirements, including GCP.
• High integrity with strong interpersonal and intellectual skills.
• Demonstrated strategic thinking, leadership, and team-building skills.
• Ability to lead by influence and possess strong problem-solving and analytical skills.
• Facilitate collaborative discussions among diverse technical groups and drive decisions on complex issues.

Nice-to-haves

• Experience with rare diseases, fibrotic diseases, and/or lung diseases.