Clinical Program Manager - Oncology
United Kingdom - Uxbridge
Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes 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. Gileads therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.
Making an impact on a global scale
Inclusion is one of the companys five core values. Thats because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.
When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible
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 study team(s) across a program within Europe and/or international studies within the Oncology Therapy Area. Meet the Clinical Operations team; http://clinicaloperations-careers.gilead.com/Essential Duties and Job Functions and Purpose of the Role:
To manage all aspects of the conduct of a clinical program(s) assigned within Europe and/or Global studies within designated programs budgets and timelines. 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.
To collaborate with colleagues in Clinical Operations, Medical Affairs, Drug Safety, Project Management, Regulatory and Clinical Research within Europe and US as required to ensure delivery of assigned programs as well as support assessment and tracking of trials.Specific Responsibilities:
Knowledge, Experience & Skills:
- Successfully manages all aspects of assigned European regional and/or Global programs within designated program budgets and timelines
- Ensure program goals are met and communicates program status updates to the management team and within cross functional meetings
- Examine functional issues from a broader organizational perspective and develop a strategy to implement within a cross-functional team
- Provide program level oversight to vendors, including CRO, central lab, and imaging
- Proactively identify potential issues/risks across the program and recommend/implement solutions
- Participate in the development of SOPs, Clinical Study Reports and other clinical, regulatory and safety documents as required
- Contribute to the 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 Kite and Gilead global process & procedure, whilst providing regional perspective & expertise to the Gilead US teams
- With limited supervision may participate in, or lead departmental strategic initiatives
- Identify any best practice opportunities to share across Gilead Therapy Areas
- Maintain current knowledge of both local & regional legislation regarding execution of oncology 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
- Travel may be required up to 20% of time
- BSc, BA or equivalent degree, higher level of degree would be advantageous but not essential
- Relevant clinical trial 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
- Experience in developing RFPs, 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, influencing 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 but not essential
- Extensive knowledge of ICH GCP, FDA and EMEA regulations & guidelines
- Must be able to resolve problems using national and international regulations, guidelines, and investigator interaction
- Knowledge of drug development & commercialization processes
- Functional expertise to initiate, author, or contribute to SOP development, implementation, and training
- Experience of participating in or leading departmental or interdepartmental strategic initiatives under limited supervision
- Must meet all requirements for the position and have demonstrated proficiency in all relevant areas
Kite and Gilead Core Value
- Experience of working within matrix organization
- Finance and budgeting experience, resource management experience
- Excellent understanding of clinical trial cycle times & associated metrics
- Expertise in Oncology would be an advantage, but is not essential
Equal Employment Opportunity (EEO)
- Integrity (always doing the right thing),
- Inclusion (encouraging diversity)
- Teamwork (collaborating in good faith),
- Excellence (working at a high level of commitment and capability)
- Accountability (taking personal responsibility).
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.
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