Clinical Program Manager – Late Phase Clinical Operations

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At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.

Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.

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Job Description

Gilead’s research and development effort has increased substantially in recent years evaluating compounds with the potential to become the next generation of innovative therapies for HIV/AIDS, oncology, cell therapy liver, and inflammatory diseases.

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.

Clinical Program Manager – Late Phase Clinical Operations

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 Non-Interventional studies, and Managed Access programs across different therapeutic areas and global/regions.

Job Overview:

• Manage all aspects of the conduct of assigned Global and/or Regional Non-Interventional studies including regulatory commitments. 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.

• May support/oversee Managed Access programs upon request.

• May be involved in recruitment, hiring and mentoring of team members, and may manage direct reports as required and support their professional development.

• Collaborate with colleagues in Clinical Operations, Medical Affairs, Pharmacovigilance, Real World Evidence, Project Management, Regulatory, Clinical Data Science and Clinical Development Globally as required ensuring delivery of assigned studies.

Job Requirements:

• Accountable for the operational execution of Non-Interventional studies within designated program budgets and timelines

• Maintain current knowledge of local & regional legislation regarding execution of Non-Interventional 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 recommendations as required.

• Development of study operational plans and documents.

• Actively participate in CRO study calls as appropriate.

• Ensure robust study feasibility in conjunction with Scientific Leads (RWE, Medical Affairs or HEOR) 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 to time, budget and quality.

• Anticipates potential project risks and implements solutions to achieve project goals engaging with cross-functional team members as appropriate.

• Ensure assigned studies are inspection ready at all times.

• May contribute to development of abstracts, presentations, and manuscripts.

• 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 and other team meetings.

• Serve as an ambassador for Clinical Operations internally and externally.

• Provide training to colleagues on process changes/improvements as necessary.

• May be involved in recruitment, hiring and mentoring of team members, and may manage direct reports as required and support their professional development.

• Occasional travel may be required.

• This is an office-based position in Stockley Park, Uxbridge, UK.

Knowledge, Experience and Skills

• BSc Life Sciences. An MSc or PhD would be advantageous (or international equivalent).

• Relevant clinical experience in the pharmaceutical industry.

• Experience in mentoring and developing junior staff.

• Experience in clinical study management including the delivery of Non-Interventional studies is essential.

• Knowledge of post-marketing requirements and different types of Non-Interventional studies including Post Authorisation Safety and Efficacy Studies.

• Experience in the provision of Managed Access would be beneficial.

• Knowledge of regulatory affairs and drug safety.

• Experience in developing RFPs and selection and management of CROs/vendors.

• Ability to write study protocols, plans, and regulatory documents (e.g. IND, NDA, 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.

• Must be able to resolve problems using national and international regulations, guidelines, and investigator interaction.

• Extensive knowledge of ICH GCP, FDA, EMEA regulations & guidelines governing Non-Interventional studies and/or Managed Access.

• Knowledge of drug development & commercialisation processes.

• Functional expertise to initiate, author, or contribute to SOP development, implementation, and training.

• Ability to participate in and/or lead departmental or interdepartmental strategic initiatives under limited supervision.

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 (https://www.myworkday.com/gilead/d/inst/13102!CK5mGhIKBggDEMenAhIICgYI1A0QtgI/cacheable-task/2997$2151.htmld#backheader=true) to apply for this job.

Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.