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Gilead Sciences, Inc. Clinical Program Manager in Uxbridge, United Kingdom

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site at https://www.myworkday.com/gilead/d/inst/13102!CK5mGhEKBggDEMenAhIHCgUI1A0QcQ/cacheable-task/2997$2151.htmld to apply for this job.

Job Description

Company

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 inflammation, liver diseases, HIV/AIDS and cancer, and serious respiratory and cardiovascular conditions.

For more information please visit Gilead.com.

The Position

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 commercialization of Gilead’s products.

For the team based in our International Headquarters in Uxbridge, we have an opportunity for a Clinical Program Manager to work within the Inflammation Therapeutic Area.

Essential Duties, Job Functions and Purpose of the Role:

  • To manage all aspects of the conduct of assigned clinical studies within designated programs budgets and timelines. This will include protocol development, feasibility, set-up and conduct, CRO selection and oversight (if necessary) and reporting according to Gilead’s SOPs and appropriate national and/or global regulation and legislation.

  • To collaborate with colleagues in Clinical Operations, Medical Affairs, Drug Safety, Project Management, Regulatory and Clinical Research within the EU and US as required to ensure delivery of assigned studies as well as support assessment and tracking of trials.

Job Requirements:

  • Successfully manage all aspects of assigned clinical studies within designated program budgets and timelines.

  • Responsible for development and monitoring of study budgets and timelines and managing adjustments as necessary.

  • Develop RFPs, select CROs/vendors, and manages external resources.

  • Communicate project status and issues and ensure project team goals are met.

  • Participate in development of SOPs, Clinical Study Reports and other clinical, regulatory and safety documents.

  • Contribute to development of abstracts, presentations, and manuscripts.

  • Develop good working relationships with the Gilead US clinical operations team and cross-functional staff internationally as required.

  • Manage assigned regional/European projects/initiatives as specifically delegated.

  • Ensure local consistency & alignment with Gilead global process & procedure, whilst providing regional perspective & expertise to the Gilead US teams.

  • May determine activities critical to company success and priorities within functional area.

  • Anticipate moderately complex obstacles and client difficulties and implements solutions to achieve project goals.

  • With limited supervision may participate in or lead departmental strategic initiatives.

  • Travel may be required occasionally.

  • Conducts study feasibility in conjunction with internal Clinical Operations staff and/or external collaborators or CROs.

  • Conduct study feasibility in conjunction with internal European Clinical Operations staff and/or external collaborators or CROs.

  • Actively lead Study Management Teams (SMTs) for assigned studies or participate on US based SMTs as necessary and provide strategic and operational advice as required.

  • Actively participate in CRO study calls as appropriate.

  • Identify any “best practice“ opportunities to share across Therapy Areas and Gilead sites.

  • Maintain current knowledge of both local & regional legislation regarding execution of clinical trials.

  • Actively participates in European Clinical Operations Management and team meetings and serve as an ambassador for Clinical Operations internally and externally.

Knowledge, Experience and Skills:

  • Educated to degree level or above within a scientific discipline

  • Relevant clinical experience in the pharmaceutical industry.

  • Line management experience or experience in mentoring and developing junior staff would be preferred.

  • Experience in clinical study management and project oversight is essential.

  • Knowledge of regulatory affairs and drug safety.

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

  • Ability to write study protocols, study reports, sections for investigator brochures, and regulatory documents with minimal supervision

  • Therapeutic area (Inflammation) experience especially Rheumatoid Arthritis and Lupus indications is preferred however not essential

  • 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.

  • Fluency in English, including both oral and written communications

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

  • Extensive knowledge of ICH GCP, FDA and EMEA regulations & guidelines.

  • 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.

  • Must meet all requirements for the position and have demonstrated proficiency in all relevant areas.

Preferred Requirements

  • Experience of working within matrix organisation.

  • Finance and budgeting experience, resource management experience.

  • Excellent understanding of clinical trial cycle times & associated metrics.

  • Expertise in Inflammation therapeutic indication would be an advantage but is not essential

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 at https://www.myworkday.com/gilead/d/inst/13102!CK5mGhEKBggDEMenAhIHCgUI1A0QcQ/cacheable-task/2997$2151.htmld to apply for this job.

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, and serious respiratory and cardiovascular conditions.

If this is not the right move for you now but remain interested in a career at Gilead Sciences please connect with us via our talent community at http://gilead.avature.net/Gilead

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