Clinical Program Manager, Clinical Operations - Late Phase
Clinical Program Manager, Clinical Operations - Late Phase
United States - California - Foster City
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
CLINICAL OPERATIONS: Clinical Operations 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 Development Operations functions, ensures that all clinical trial activities are performed in accordance with all 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.
Clinical Program Manager, Clinical Operations (CPM)- Late Phase
We are seeking a talented, experienced, and highly motivated candidate to succesfully manage Gilead Sponsored Non-Interventional studies, across Gilead's therapeutic areas. The candidate must have the ability to work independently, be an effective leader, and an engaged team member in a dynamic, fast-paced environment.
Specific Responsibilities and Skills for Position:
- Manage all aspects of the conduct of assigned Non-Interventional studies (e.g.Post Authorisation Safety studies, Patient Registries, HCP Survey, Real World Evidence, Prospective and Retrospective data collection studies).
- 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.
- 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
- May support/oversee Compassionate Use programs.
- Collaborate with colleagues in Clinical Operations, Medical Affairs, Pharmacovigilance & Epidemiology, Project Management, Regulatory, Biometrics and Clinical Research within the US and EU as required ensuring delivery of assigned studies.
- Identify any best practice opportunities to share across Therapeutics Areas and Gilead sites.
- 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.
- 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.
- 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
- Thorough knowledge and understanding of FDA and/or EMA Regulations (or relevant local regulations), ICH Guidelines, and GCPs governing the conduct of clinical trials and non-interventional studies
Experience and Skills:
- At least 8+ years of experience and a RN (2 or 3 year certificate) or BS/BA in a relevant scientific discipline
- At least 6+ years of experience and a Masters' degree or higher; scientific discipline preferred
- Experience in company sponsored clinical trial management is essential.
- Experience in Phase IV and non-interventional studies preferred.
- Experience in the review and oversight of Investigator Sponsored & Collaborative Research would be beneficial.
- Experience in the provision of compassionate use would be beneficial
For jobs in the United States:
As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact firstname.lastname@example.org for assistance.
For more information about equal employment opportunity protections, please view the EEO is the Law' poster.
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Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.
Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
For Current Gilead Employees and Contractors:
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