Senior Director, Global Clinical Operations

Regulatory Jobs; Foster City (CA); On-site; USD 210,000 - 272,000; Full time

Benefits offered by this job

Discretionary annual bonus

Stock-based long-term incentives

Paid time off

Benefits package

Job summary

Gilead Sciences Inc. in Foster City, CA or Parsippany, NJ is seeking a senior clinical trials leader to oversee international Phase I–IV programs across multiple indications, with CROs and internal resources.

Extensive regulatory and scientific leadership is required, including budget oversight, strategic direction, SOP development, and cross-functional collaboration. Travel awareness and mentorship of staff are key components.

Qualifications

• 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)

Responsibilities

• Provides leadership and therapeutic expertise for the successful management of international clinical trials (Phase I - IV) across multiple indications through clinical study teams and through the use of CROs or internal resources.
• Responsible for oversight and strategic direction and implementation across a number of projects to ensure clinical programs are conducted to meet project milestones and budgets through close partnership with parties involved both inside and outside of the company.
• Initiates continuous efforts in reviewing and identifying best practices among study teams and enforcing standardization among teams.
• Directs development of SOPs within department and participates in development of collaborative SOP development.
• May contribute to Clinical Study Reports, INDs, NDAs, and other clinical/regulatory/safety documents.
• Contributes to development of abstracts, presentations, and manuscripts.
• Manages study teams to ensure deployment of resources.
• Travels nationally and internationally as required.
• Represents the company at professional events and may present company clinical initiatives and findings at such events.
• Extensive clinical experience is required.
• Excellent verbal, written, interpersonal skills, and ability to lead multifunctional teams, ability to manage staff, and mentor junior staff is required.
• Must be able to solve complex problems and use highly developed independent judgment relating to national and international regulations, guidelines, investigator interactions and timelines.
• Must be able to successfully develop, implement, manage and complete complex clinical trials and manage vendor relations.
• Must think critically and creatively and be able to work independently to determine appropriate resources for resolution of complex problems.
• Demonstrated excellence in complex project management and effectively managing multiple projects/priorities is required.
• 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 is required.
• Experience with presentations before executive staff.
• Extensive experience in developing RFPs, selection of CROs/vendors, and management of external resources is required.
• Demonstrated ability to manage international clinical trials within designated program budgets and timelines is required.
• Demonstrated ability to manage budgets.
• Proven ability to effectively communicate scientific, medical, and organizational concepts to internal and external customers.
• Ability to initiate, and lead departmental or interdepartmental strategic initiatives.

Skills

Leadership

Regulatory strategy

Cross-functional leadership

Clinical trials management

Project management

Communication

Education

BS in a relevant scientific discipline

MS degree

RN (2 or 3 year certificate)

Job description

Gilead Sciences Inc. in Foster City, CA or Parsippany, NJ is seeking a senior clinical trials leader to oversee international Phase I–IV programs across multiple indications, with CROs and internal resources.

Extensive regulatory and scientific leadership is required, including budget oversight, strategic direction, SOP development, and cross-functional collaboration. Travel awareness and mentorship of staff are key components.