Clinical Program Manager - Observational Research
Clinical Program Manager - 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
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 professional 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 a Clinical Program Manager to be responsible for the management of post-authorisation studies, investigator sponsored research and compassionate use programs across different therapeutic areas.
- Manage all aspects of the conduct of assigned post-authorisation (PAS) studies including PASS and PAES within EMEA and potentially globally. This will include protocol development, 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.
- Provides support to Investigator Sponsored Research (ISR) including Fair Market Value and feasibility assessment, financial milestone advice, contract negotiation support, tracking and publication follow-up.
- May support/oversee Compassionate Use programs upon request.
- Recruit, hire, mentor, and manage direct reports as required and support their professional development.
- Collaborate with colleagues in Clinical Operations, Medical Affairs, Pharmacovigilance & Epidemiology, Project Management, Regulatory, Biometrics and Clinical Research within the EU and US as required ensuring delivery of assigned studies.
Role Requirements & Responsibilities:
- Successfully manages all aspects of assigned post-authorisation studies within designated program budgets and timelines with primary focus on studies detailed in the product Risk Management Plan.
- Maintain current knowledge of both local & regional legislation regarding execution of post-authorisation studies.
- Responsible for development and monitoring of study budgets and timelines and managing adjustments as necessary.
- Actively lead Study Management Teams (SMTs) for assigned studies and provide strategic and operational advice as required.
- Conduct study feasibility in conjunction with internal Medical Affairs and Clinical Operations staff and/or external collaborators or CROs.
- Develops RFPs, select CROs/vendors, and manages external resources.
- Communicates project status and issues and ensure project team goals are met.
- Anticipates moderately complex obstacles and client difficulties and implements solutions to achieve project goals.
- Contributes to development of abstracts, presentations, and manuscripts.
- Provide support to Investigator Sponsored Trials including Fair Market Value and feasibility assessment, contract milestone advice, tracking and publication follow-up as required
- Identify any best practice opportunities to share across Therapeutics Areas and Gilead sites.
- Ensure local consistency & alignment with GSI global process & procedure, whilst providing regional perspective & expertise.
- Participate in the development of SOPs, Clinical Study Reports, INDs, NDAs, and other clinical, regulatory and safety documents as required.
- With limited supervision may participate in or lead departmental strategic initiatives.
- Develop good working relationships with the Global Late Phase operational team and cross-functional staff internationally as required.
- Participate as an active member of the Global Clinical Operations Late Phase extended Leadership team and other team meetings.
- Occasional travel is required.
Knowledge, Experience and Skills
- Educated to degree level or above within Life Sciences or similar. A
- Relevant clinical experience in the pharmaceutical industry.
- Experience in managing staff as well as mentoring and developing junior staff.
- Experience in clinical study management including the delivery of Phase IV and non-interventional studies is essential.
- Experience in the review and oversight of Investigator Sponsored Research.
- Knowledge of post-marketing requirements and different types of Drug Utilisation Studies and Post Authorisation Safety and Efficacy Studies.
- Experience in the provision of compassionate use would be beneficial.
- Experience in developing RFPs and selection and management of CROs/vendors.
- Ability to write study protocols, plans, study reports and regulatory documents (e.g. IND, DNA, etc.) with little supervision.
- Excellent interpersonal skills, and demonstrated ability to lead is required.
- Strong communication and influence skills and ability to create a clear sense of direction is necessary.
- Extensive knowledge of ICH GCP, FDA, EMEA regulations & guidelines.
- Knowledge of drug development & commercialisation processes.
- Functional expertise to initiate, author, or contribute to SOP development, implementation, and training.
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:
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