Director, Clinical Development Lead (Non-MD)

Gilead Sciences Inc.; Foster City (CA); In loco; USD 243.000 - 315.000; Tempo pieno

Descrizione del lavoro

Gilead Sciences Inc. in Foster City, CA, is seeking a leader in clinical development to guide late-stage programs, including protocol design, study reports, and regulatory deliverables.

This role provides medical monitoring, data review, and cross-functional leadership across teams, with focus on Phase 3 studies and postmarketing commitments; requires advanced degrees and 6+ years in biopharma.

The position offers a competitive salary and comprehensive benefits.

Competenze

• Demonstrated clinical development expertise in biopharma.
• Strong cross-functional leadership and communication.
• Experience with data analysis, study design, and regulatory interactions.

Mansioni

• Support or lead clinical development activities across assigned projects, including protocol preparation, study documentation, data analysis planning, study reporting, publications, and scientific presentations.
• Provide scientific and clinical guidance to cross-functional teams to support clinical development deliverables and timelines.
• Provide input into, or lead, clinical trial protocol design, clinical study reports, and responses to health authority inquiries.
• Provide input into or lead development of the Target Product Profile and Clinical Development Plan for assigned molecules or products.
• Provide ongoing medical monitoring for clinical trials, including assessment of eligibility criteria, toxicity management, and drug safety surveillance.
• Coordinate the collection and synthesis of ongoing clinical data for internal analysis and review.
• Coordinate and manage the preparation and/or review of data listings, summary tables, study results, and scientific presentations.
• Contribute clinical development expertise to data analysis plans and the interpretation and synthesis of data from Phase 3 and other clinical studies.
• Support activities associated with global registration of a late-stage therapeutic in clinical development.
• Assist with execution of clinical postmarketing requirements and other clinical development commitments.
• Manage clinical development contributions to the preparation and review of regulatory documents, investigator brochures, and development plans.
• Present scientific information at scientific conferences and clinical study investigator meetings.
• Conduct clinical development activities in accordance with applicable regulatory requirements, Good Clinical Practice (GCP), and Gilead standard operating procedures.
• Lead or contribute to cross-functional project and program teams to deliver clinical development objectives.
• Manage multiple clinical development deliverables and priorities through matrix management and leadership.
• Communicate project direction and status across organizational levels, including leadership teams, executives, and steering committees.
• Apply analytical judgment and relevant disease-area expertise to clinical development activities and deliverables.

Conoscenze

Leadership

Cross-functional collaboration

Clinical development

Regulatory understanding

Formazione

PharmD or PhD in clinical research or clinical pharmacology

Descrizione del lavoro

Gilead Sciences Inc. in Foster City, CA, is seeking a leader in clinical development to guide late-stage programs, including protocol design, study reports, and regulatory deliverables.

This role provides medical monitoring, data review, and cross-functional leadership across teams, with focus on Phase 3 studies and postmarketing commitments; requires advanced degrees and 6+ years in biopharma.

The position offers a competitive salary and comprehensive benefits.