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, liver diseases, cancer, inflammatory and respiratory diseases and cardiovascular conditions. As a result of this strong drug pipeline Gilead’s fast paced Clinical Operations team in EMEA is growing.
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 and challenging opportunity has arisen to join the European Late Phase Team and be based in our Paris Affiliate Office, as a Clinical Program Manager to be responsible for the management of post-authorisation studies across different therapeutic areas.
Meet the Clinical Operations team; http://clinicaloperations-careers.gilead.com/
- To manage all aspects of the conduct of assigned post-authorisation (PAS) studies including PASS and PAES within the EU and potentially globally. 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 ensuring delivery of assigned studies.
- To support assessment and tracking of Investigator Sponsored Research (ISR).
- Successfully manages all aspects of assigned international post-authorisation studies within designated program budgets and timelines with primary focus on studies detailed in the product Risk Management Plan.
- Responsible for development and monitoring of study budgets and timelines and managing adjustments as necessary.
- Develops RFPs, select CROs/vendors, and manages external resources.
- Participates in development of SOPs, Clinical Study Reports, INDs, NDAs, and other clinical, regulatory and safety documents.
- Contributes to development of abstracts, presentations, and manuscripts.
- Develops good working relationships with Gilead EU and US Late Phase operational teams and cross-functional staff internationally as required.
- Manages assigned regional/global projects/initiatives as specifically delegated.
- Ensures local consistency & alignment with Gilead global process & procedure, whilst providing regional perspective & expertise to the Gilead US teams
- Participate in or lead departmental strategic initiatives.
- Conducts study feasibility in conjunction with internal Medical Affairs and 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.
- Provides support to Investigator Sponsored Research including Fair Market Value and feasibility assessment, contract milestone advice, tracking and publication follow-up as required.
- Actively participates in Clinical Operations International Management and team meetings.
- Recruits, hires, mentors, and manages direct reports as required and supports their professional development.
- 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 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 of the provision of compassionate use supply including nATU/cATU and RTU.
- 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 brochure and regulatory documents (e.g. IND, DNA, etc.) with little supervision.
- Must be able to resolve problems using national and international regulations, guidelines, and investigator interaction.
- Extensive knowledge of ICH GCP, FDA, EMEA and French regulations & guidelines.
- 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.