Clinical Program Manager - Late Phase

Clinical Program Manager - Late Phase

Gilead

Uxbridge, United Kingdom

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.

Job Overview:

  • 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.

Job Requirements:

  • 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;
    • Actively participate in CRO study calls as appropriate;
    • 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;
    • Co-monitoring may be required.
  • 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;
  • Serve as an ambassador for Clinical Operations internally and externally;
  • Provide training to colleagues on process changes/improvements as necessary;
  • Recruit, hire, mentor, and manage direct reports as required and support their professional development;
  • Occasional travel is required.

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 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;
  • Knowledge of regulatory affairs and drug safety;
  • 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;
  • Must be able to resolve problems using national and international regulations, guidelines, and investigator interaction;
  • 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;
  • Ability to participate in and/or lead departmental or interdepartmental strategic initiatives under limited supervision.

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© EuroJobsites 2020

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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