Associate Director, Clinical Operations - Observational Research

Location
Foster City
Salary
See job description.
Posted
September 12 2021
Ref
R0020394
Position Type
Full Time
Organization Type
Pharma
Job Type
Manager


Associate Director, Clinical Operations - Observational Research
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

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Led by a team of well-established Clinical Operations professionals, careers within the Clinical Operations team offers individuals the opportunity to develop their knowledge & experience rapidly whilst enjoying a supportive and team-focused working environment. Gilead's operational model allows each Clinical Operations professionals to make a genuine impact on the business and ultimately our ability to deliver live changing therapeutics to those in need.

An exciting opportunity has arisen to join the Clinical Operations Late Phase team based within the European Headquarters in Stockley Park, Uxbridge as an Associate Director to be accountable for the successful management of Post-Authorisation Non-Interventional studies, Investigator Sponsored Research and Compassionate Use programs across different therapeutic areas.

Job Responsibilities and Skills:
  • Manage all aspects of Gilead Sponsored Non-Interventional studies (e.g. Post Authorisation Safety studies, Patient Registries, HCP Survey, Real World Evidence, Prospective and Retrospective data collection studies). This includes protocol development, budget forecasting and tracking, feasibility, set-up and conduct, CRO selection and oversight, and reporting according to Gilead's SOPs and appropriate national and/or global regulation and legislation.
  • Provide leadership, expertise and strategic direction for the successful management of Gilead Sponsored Non-Interventional studies, across different therapeutic areas.
  • Effectively solve problems and use judgment relating to national and international regulations, guidelines, investigator interactions and timelines
  • Lead cross-functional study management team (SMT) and together with study stakeholders mitigate risks to ensure project success
  • Provide leadership and support for effective management of Investigator Sponsored and Collaborative Research, across different therapeutic areas.
  • May support/oversee Compassionate Use programs.
  • Recruit, hire, mentor, and manage direct reports as required and support their professional development.
  • Initiate, participate in and/or lead departmental or interdepartmental strategic initiatives
  • Participate in the development of SOPs, Clinical Study Reports, INDs, NDAs and other clinical, regulatory and safety documents
  • Provide input into the management of the Clinical Operations department
  • Participate as an active member of the Global Clinical Operations Late Phase Extended Leadership team and other team meetings.
  • Collaborate with colleagues in Clinical Operations, Medical Affairs, Real World Evidence, Project Management, Regulatory, Clinical Data Science and Clinical Research globally


Knowledge, Experience and Skills
  • BSc Life Sciences. A MSc or PhD would be advantageous (or international equivalent).
  • Relevant clinical experience in the pharmaceutical industry.
  • Experience in clinical study management including the delivery of Phase IV non-interventional studies is essential.
  • Experience in Investigator Sponsored Research would be beneficial.
  • Experience in the provision of compassionate use would be beneficial.
  • Thorough knowledge and understanding of FDA and/or EMA Regulations (or relevant local regulations), ICH Guidelines, and GCPs governing the conduct of non-interventional studies
  • Proven ability for successful study implementation and completion
  • Financial Accountabilities for Clinical Study Budgets
  • Recognizes and escalates critical issues in a study that may impact the strategic business or financial goals of the Company's overall business
  • Ability to participate in and/or lead departmental or interdepartmental strategic initiatives under limited supervision.
  • Excellent interpersonal skills, ability to lead multifunctional teams, ability to manage staff and mentor junior staff is required
  • Must possess a proven ability to effectively communicate scientific, medical, and organizational concepts to internal and external customers


Gilead Core Values
  • Integrity (always doing the right thing),
  • Inclusion (encouraging diversity)
  • Teamwork (collaborating in good faith),
  • Excellence (working at a high level of commitment and capability)
  • Accountability (taking personal responsibility).


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:

Please log onto your Internal Career Site to apply for this job.
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To apply, visit https://gilead.wd1.myworkdayjobs.com/en-US/gileadcareers/job/United-Kingdom---Uxbridge/Clinical-Program-Manager---Observational-Research_R0020394-1





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