Clinical Program Manager Job Position @ GILEAD: 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.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 Headquarters based in Stockley Park, Uxbridge as a Clinical Program Manager to be responsible for the management of all aspects of assigned international studies within the Inflammation Therapeutic Area.
Clinical Program Manager Job Position @ GILEAD
- To manage all aspects of the conduct of assigned European studies within designated programs 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.
- Anticipate moderately complex obstacles and client difficulties and implements solutions to achieve project goals.
- Conducts study feasibility in conjunction with internal Clinical Operations staff and/or external collaborators or CROs.
- 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.
- Recruit, hire, mentor, and manage direct reports as required and support their professional development.
- BSc Life Sciences. A MSc* or PhD would be advantageous (or international equivalent)
- Relevant clinical experience in the pharmaceutical industry.
- Solid line management experience including managing staff as well as mentoring and developing junior staff.
- Experience in clinical study management and project oversight is essential.
PREFERRED SKILLS (Clinical Program Manager Job Position):
- 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
- 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. Proficiency in another European language(s) would be advantageous
- 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.
- 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.
Clinical Program Manager – Inflammation
Ref. Number: 33081
Location: United Kingdom – Stockley Park
Functional Area: Clinical
Position Type: Regular
Working Hours: Full Time
Clinical Program Manager Job Position @ GILEADApply Now
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