Director, Clinical Operations - Oncology
Director, Clinical Operations - Oncology
United Kingdom - Uxbridge
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
Gilead has declared oncology as one of the key therapeutic areas for future growth. Gilead is growing its pipeline in immune oncology through internal research, partnerships and acquisitions.
The Clinical Operations team is responsible for the execution of all Phase 1-4 clinical trials, across all therapeutic areas, around the world. In partnership with Clinical Research, Medical Affairs and other Development Operations functions, Clinical Operations ensures that all clinical trial activities are performed in accordance with applicable SOPs, company policies and regulatory guidelines to provide timely delivery of high-quality clinical data to support global registration and commercialisation of Gilead's products.
This is a new position and opportunity to become a member of the Oncology Leadership Team, responsible for the effective delivery of Clinical Operations accountabilities and will report to the Senior Director, Oncology Clinical Operations based in Stockley Park.
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, PVG, Regulatory, Biometrics, Clinical Pharmacology, Clinical Supply Management, Medical Affairs, etc) to ensure on-budget, timely, high quality delivery of the programs
- Particular interest in oncology solid tumour programmes and experience of building and developing site relationships, while ensuring the clinical trials are completed with quality and according to study timelines
- Experience of working collaboratively with medical affairs in the exchange of information and coordination of investigator site interactions across a broad portfolio
- Proven ability to effectively communicate complex scientific, medical, and organisational concepts both internally and externally
- Potentially serves or deputises directly as required 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.
- Works with project teams to develop and oversee clinical trial/ program budgets, timelines and resource plans
- 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 standardisation among teams
Knowledge, Experience and Skills:
- Educated to degree level or above within a relevant scientific discipline
- Prior oncology clinical trials experience required
- Ability to lead cross-functional teams
- A Team Builder: ability to manage and mentor staff is required
- Ability to rapidly study, analyse and understand new situations and business problems.
- Thorough knowledge and understanding of FDA and EMA Regulations, ICH Guidelines, and GxPs governing the conduct of clinical trials
- Demonstrated excellence in complex project management and effectively managing multiple projects/priorities is required
- Experience with delivering presentations before executive staff and large cross-functional audiences is required
- Operationally excellent and drives others towards excellence
- Resilient in the context of a rapidly changing environment
- Organised with a systematic approach to prioritisation
Gilead Core Values
- Integrity (Doing What's Right)
- Teamwork (Working Together)
- Excellence (Being Your Best)
- Accountability (Taking Personal Responsibility)
- Inclusion (Encouraging Diversity)
Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercialises 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.
Equal Employment Opportunity (EEO)
It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively "Gilead" or the "Company") to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law, all employment actions relating to issues such as compensation, benefits, transfers, layoffs, returns from layoffs, company-sponsored training, education assistance, social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds, which may include an individual's gender, race, color, national origin, ancestry, religion, creed, physical or mental disability, marital status, sexual orientation, medical condition, veteran status, and age, unless such protection is prohibited by federal, state, municipal, provincial, local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.
For Current Gilead Employees and Contractors:
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