Clinical Program Manager, Clinical Operations - Virology
Clinical Program Manager, Clinical Operations - Virology
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 - Virology (CPM)
*Located in Foster City, CA
We are seeking a talented, experienced, and highly motivated candidate to join the Virology Clinical Operations team. 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:
- Ability to write study protocols, study reports, and regulatory documents (e.g. IND, NDA, PRAC etc.) with little supervision
- Contributes to development of abstracts, presentations, and manuscripts
- Must have a demonstrated ability to successfully develop, implement, manage and complete clinical trials
- Provides guidance and oversight for the successful management of all aspects of international clinical trials within designated program budgets and timelines
- Experience in managing staff as well as mentoring and developing junior staff is required
-Partners with cross functional teams to manage, adjust, and revise project timelines/budgets as necessary
- Communicates project status and issues and ensure project team goals are met
- Experience in developing RFPs and selection and management of CROs/vendors
- Functional expertise to initiate, author, or contribute to SOP development, implementation and training
- Recruits, hires, mentors and manages CPA/CTMA/Sr. CTMA/CTM/Sr. CTM direct reports and supports their professional development
- Anticipates moderately complex obstacles and client difficulties and implements solutions to achieve project goals
- Must be able to resolve problems using national and international regulations, guidelines and investigator interaction
- May design and use all available vehicles for scientific communication within company. With limited supervision may participate in or lead departmental strategic initiatives
- Ability to participate in and/or lead departmental or interdepartmental strategic initiatives under limited supervision
- Ability to examine functional issues from a broader organizational perspective
- 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
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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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