Director, Clinical Operations

About the role

Gilead Sciences is seeking a dynamic and experienced individual to join our team as a Clinical Trial Leader. This role involves leading and overseeing oncology clinical trials, including Phase 1 first-in-human studies, and managing clinical study teams and CROs.

Responsibilities

• Provides leadership and therapeutic expertise for the successful management of international clinical trials (Phase I - IV) across multiple indications.
• Oversees and directs the strategic direction and implementation of clinical programs to meet project milestones and budgets.
• Develops and enforces standard operating procedures (SOPs) within the department and collaborates with others to develop SOPs.
• Contributes to the development of Clinical Study Reports, Investigational New Drug (IND) applications, New Drug Applications (NDA), and other clinical/regulatory/safety documents.
• Manages study teams to ensure effective resource deployment.
• Represents the company at professional events and presents clinical initiatives and findings.
• Manages international clinical trials within designated program budgets and timelines.
• Manages budgets and effectively communicates scientific, medical, and organizational concepts to internal and external customers.
• Manages cross-functional teams and direct reports.
• Manages vendor relations and develops Requests for Proposal (RFPs).
• Manages and implements complex clinical trials.

Requirements

• 12+ years of experience and a BS in a relevant scientific discipline.
• 12+ years of relevant experience and a MS degree.
• 14+ years of experience and an RN (2 or 3 year certificate).
• Prior experience leading and overseeing oncology clinical trials with a minimum of 5 years’ experience in the design and delivery of Phase 1 first in human (FIH) oncology clinical trials.

Qualifications

• Extensive clinical experience.
• Excellent verbal, written, interpersonal skills, and ability to lead multifunctional teams.
• Ability to manage staff and mentor junior staff.
• Independent judgment relating to national and international regulations, guidelines, investigator interactions, and timelines.
• Experience managing cross-functional teams or work groups as well as direct reports.
• Demonstrated understanding of pharmaceutical regulatory requirements and impact on development of clinical trials.
• Experience with presentations before executive staff.
• Experience with developing RFPs, selecting CROs/vendors, and managing external resources.
• Demonstrated ability to manage international clinical trials within designated program budgets and timelines.
• Proven ability to effectively communicate scientific, medical, and organizational concepts to internal and external customers.
• Proven ability to manage budgets.

Skills

• Complex project management.
• Independent problem-solving and creative thinking.
• Effective communication and leadership skills.

Benefits

This role offers a competitive salary range of $210,375.00 - $272,250.00, along with a comprehensive benefits package including medical, dental, vision, and life insurance plans. Additional benefits information can be found on our careers website.

For current Gilead employees and contractors, please apply through the Internal Career Opportunities portal in Workday.