Manager, Development Business Operations - Vendor Outsourcing
Manager, Development Business Operations - Vendor Outsourcing
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
Gilead Sciences is currently hiring a Manager, Outsourcing / Development Business Operations with expertise in clinical outsourcing of global Phase I-IV clinical trials. The successful candidate will have broad clinical operations and direct outsourcing experience (may include CRO, Central Lab, Specialty Lab, Biometrics, Clinical Pharmacology, eCOA, IxRS, and other ancillary clinical sourcing), preferably in Oncology, Cell Therapy, Inflammation, Liver Disease and HIV. The Manager is responsible for the entire life cycle of vendor selection, including RFI, RFP, vendor selection decision, contracting, monitoring performance, managing the change order process, and ensuring proper closeout of clinical agreements. The candidate will have a proven success record of working in a matrix environment, and regularly collaborating with cross functional teams, such as, clinical operations, finance, legal, business conduct, vendor management and payments. In addition, the Manager will have excellent communication skills and is comfortable interacting with internal and external teams of all levels, including Senior Management.
- This role can manage and complete complex to non-routine clinical contracts and finance processes.
- Manages operational functions and may include supervision of other staff members. May manage staff grade 27 and below.
- Manages moderately complex clinical supplier contract activities for multiple clinical development programs including CROs.
- Will focus on outsourcing and contracts, and the financial management of contracts throughout the life cycle of the study.
- Manages contract activities for multiple clinical development programs, ensuring there are adequate staff with the skills to complete Development Operations contracts accurately, consistently and in a timely manner.
- Participates in establishing departmental and cross-functional policies and procedures. Assists other staff in resolving moderately complex issues relating to contract negotiation or management.
- Trains staff in contract budgeting, development, and administration, as applicable.
- Develops spreadsheets and tracking tools.
- Manages study level vendor relationships in conjunction with the Vendor Relationship Management and Development Operations groups.
- Works with internal customers in vendor bidding and proposal development (RFP creation and analysis)
- Assists with vendor presentation preparation and may manage Vendor bid defense meetings.
- With the support of internal customers and the Legal department, manages the contract negotiation process, especially in more complex, or high value contracts
- Leads contract life cycle management process related to various vendor agreements
- Completes tasks and projects under minimal to no supervision.
- Travel may be required
Knowledge, Experience and Skills:
- 7+ years of experience with a BA in a relevant discipline.
- 5+ years of experience with a MS/MBA in a relevant discipline.
- Relevant experience typically includes contract negotiation and/or clinical finance.
- Demonstrates excellent verbal, written, and interpersonal communication skills and in-depth knowledge of clinical study functions.
- Demonstrates strong understanding of regulatory and legal issues pertinent to clinical development (Contracts).
- Must be able to interact on high level with the clinical teams, clinical finance and external partners to provide oversight of clinical budgets.
- Demonstrates a basic understanding of the regulatory implications of contracts as related to clinical research (Finance).
- Demonstrates ability to managing competing priorities effectively and proficiently.
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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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