Director, Clinical Operations - Oncology (Foster City)

Location
Foster City, CA, United States
Posted
Dec 19, 2020
Ref
2106260
Required Education
Bachelors Degree
Position Type
Full time
Director, Clinical Operations - Oncology (Foster City)
United States - California - Foster City

Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead’s therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.

Making an impact on a global scale
Inclusion is one of the company’s five core values. That’s because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.

When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible


Director, Clinical Operations - Oncology

*Located in Foster City, CA

This position is a member of the Oncology Leadership Team responsible for the effective delivery of Clinical Operations accountabilities and will report to the Sr. Director, Oncology CO.

Specific Responsibilities and Skills for Position:
  • Member of the Oncology Leadership Team, responsible for effective oversight of designated personnel and programs, as well as driving department goals and initiatives to desired outcomes
  • Proven ability and experience to effectively manage Phase 1-3 clinical trials globally within designated program budgets and timelines, to enable translation to appropriate oversight at this level
  • Strong collaboration and partnership with cross functional colleagues globally (Clinical Research, Project Management, PVE, Regulatory, Biometrics, Clinical Pharmacology, CSM, Medical Affairs, etc) to ensure on-budget, timely, high quality delivery of the programs
  • Serves directly on development project teams, and/or oversees direct reports serving on DPTs, ensuring clinical operations strategic and operational input. Active influence in clinical development plans and accountable for clinical operations deliverables.
  • Manages people managers and/or study teams to ensure optimal deployment of resources
  • Recruits, hires, mentors, and manages direct reports as required and supports their professional development
  • Extensive experience in evaluating and managing CROs/vendors with ability to provide operational oversight; serves as program or TA representative for vendor oversight and governance meetings
  • May serve as clinical operations representative on corporate partnerships, due diligence, and/or acquisition integration team(s), providing clinical operations input and review of partnership documents
  • Initiates continuous efforts in reviewing and identifying best practices among study teams and enforcing standardization among teams
  • Directs development of procedural documents within department and cross-functionally
  • Travels nationally and internationally as required


Knowledge:
  • Excellent verbal, written, interpersonal skills, and
  • Ability to lead cross-functional teams
  • A Team Builder: ability to manage and mentor staff is required
  • Demonstrated excellence in complex project management and effectively managing multiple projects/priorities is required
  • Thorough knowledge and understanding of FDA and EMA Regulations, ICH Guidelines, and GxPs governing the conduct of clinical trials
  • Experience with delivering presentations before executive staff and large cross-functional audiences is required
  • Critical and creative thinker; able to work independently to determine appropriate resources for resolution of complex problems
  • Compiles, assesses and communicates risks and optionality to support informed decision making for operational strategy
  • Demonstated leadership to motivate teams and drive performance


Experience and Skills:
  • At least 12+ years of experience and a RN (2 or 3 year certificate), BS/BA, or higher degree in a relevant scientific discipline
  • At least 10+ years of experience and a Masters' degree or higher; scientific discipline preferred
  • Prior oncology clinical trials experience required


Behaviors:
  • Ability to rapidly study, analyse and understand new situations and business problems. Curious in planning; agile in execution.
  • Operationally excellent and drives others towards excellence
  • Resilient in the context of a rapidly changing environment
  • Organised with a systematic approach to prioritization
  • Exhibits Gilead's Leadership Commitments:
    • To Be Bold (in aspiration and agile in execution)
    • To Care (and make time for people)
    • To Listen (speak openly and explain the ‘why')
    • To Own (the impact of your words and actions)
    • To Trust (others and yourself to make sound decisions).
  • Lives the Gilead Core Values daily
    • Integrity (always doing the right thing),
    • Teamwork (collaborating in good faith)
    • Excellence (working at a high level of commitment and capability)
    • Accountability (taking personal responsibility)
    • Inclusion (encouraging diversity)

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As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact careers@gilead.com for assistance.

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