Director, Clinical Operations - Oncology - Early Phase
Director, Clinical Operations - Oncology - Early Phase
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. Gileads 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 companys five core values. Thats 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/ Sr. Director, Clinical Operations - Oncology
We are seeking a strong, experienced Director or potentially Sr Director, for Clinical Operations in our Oncology therapeutic area studies. This position is a member of the Oncology Leadership Team responsible for the effective operational delivery and oversight of early development clinical programs, and will report to the Executive Director, Clinical Operations Oncology.
Foster City, CA or Remote
- 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
- Clinical operations oversight of early development oncology programs, including tracking and managing deliverables and working cross-functionally with key stakeholders to optimize processes as related to early phase studies in efforts to streamline timelines without compromising quality data deliverables
- 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
- Clinical operations representative on early development global development teams (GDT) and/or oversees direct reports serving on GDTs, ensuring clinical operations strategic and operational input to clinical development programs. Able to influence clinical development plans and is accountable for clinical operations deliverables, timelines and budgets
- Develops resource plans for programs under oversight, and oversees study teams to ensure optimal deployment and allocation of resources
- Manages people managers; recruits, hires, mentors, and manages direct reports as required and supports their professional development
- 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 identifying and applying best practices and enforcing standardization among teams and across programs
- Active participation and leadership in clinical operations and cross-fuctional organizational initiatives to drive improvements in effiency and operational excellence
- May lead development of procedural documents within department and cross-functionally
- serves as program or TA representative for vendor oversight and governance meetings
- Travels nationally and internationally as required
- Excellent verbal, written, and interpersonal skills
- Proven ability and experience to effectively execute early phase (e.g., phase 1, first-in-human, dose-escalation, safety studies) clinical trials within designated program budgets and timelines
- Demonstrated excellence in complex project management and effectively managing multiple projects/priorities 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
- Effectively utilizes tools (reports, dashboards) to track and oversee programs, and communicate appropriately to key stakeholders
- Strong financial acumen and ability to critically develop, review and track program budgets
- Ability to build and lead high-functioning teams, both within clinical operations and cross- functionally
- Thorough knowledge and understanding of FDA and EMA Regulations, ICH Guidelines, and GxPs governing the conduct of clinical trials
Experience and Skills:
- At least 12+ years of experience and a BS/BA or higher degree in a relevant scientific discipline. MS/MA or higher will need 10+ yrs experience.
- Prior oncology early phase clinical trials experience required
- RN (2 or 3 year certificate) highly desired
- Extensive experience in evaluating and managing CROs/vendors with ability to provide operational oversight
- Ability to rapidly study, analyse and understand new situations and business problems and identify appropriate solutions
- Curious in planning; agile in execuition
- 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)
For jobs in the United States:
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 email@example.com for assistance.
For more information about equal employment opportunity protections, please view the EEO is the Law' poster.
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Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.
Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.
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