Director, Clinical Operations
About The Position
At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.
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
- 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 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.
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.
- Must be able to successfully develop, implement, manage and complete complex clinical trials and manage vendor relations.
- Ability to initiate, and lead departmental or interdepartmental strategic initiatives.
Benefits
- discretionary annual bonus
- discretionary stock-based long-term incentives
- paid time off
- company-sponsored medical, dental, vision, and life insurance plans
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What This Job Offers
Job Type
Full-time
Career Level
Director
