Manager, Development Business Operations
Manager, Development Business Operations
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
Position will be accountable for the drafting, negotiation, and review of global Phase I through IV clinical investigative site and related ancillary contracts (together referred to as site contracts) including both language and budget, the management of Functional Service Providers (FSPs) involved in the contracting process. Will require oversight of contract activities for multiple clinical development programs within the various Gilead therapeutic areas, ensuring Gilead Contract Managers and FSP provide adequate level of staff to complete contracts in an accurate, consistent, and timely manner. Must coordinate with the FSPs, Gilead Clinical Operations and Gilead Legal departments to manage and complete the site contract process throughout study duration. Responds and resolves complex issues associated with domestic and international contracts with support from more senior staff and Gilead Legal department. Ideal candidate will have demonstrated success in working collaboratively with stakeholders, especially senior Development Business Operations management.
- This role can manage the day-today activities in complex clinical trials contracts (CTA) and budget negotiation processes.
- Focuses on site clinical trials contracting, fair market value (FMV) compliance of site contracts, and accountability as it relates to FSP management and site start-up.
- Works with Functional Service Provider (FSP) to implement Site Contracts CALM Contracts Process to ensure efficient delivery of fully executed contracts.
- Manages the day-to-day activities of multiple areas in moderately complex clinical contracts and finance. Including but not limited working closely with internal clinical operations as it related to rapid study sites.
- Evaluates contract and budget changes requested within CTA and identifies business and/or legal risks manage the issue to resolution by proposing and providing alternative solutions to legal or senior management.
- Identifies issues/problems and provides recommendations for solutions.
- Demonstrates ability to make critical decisions related to projects and tasks.
- Demonstrates ability to work in fast paced and changing environment
- Assists other staff in resolving moderately complex issues relating to contract negotiation and management.
- Ability to develop use spreadsheets and tracking tools.
- Manages relationships in conjunction with the Clinical Operations as it relates to clinical trials contracts
- With the support of internal customers and the legal department, within the contract negotiation process.
- Leads the contract life cycle management process for assigned Clinical Trial Study.
- Demonstrates excellent verbal, written, and interpersonal communication skills.
- This role demonstrates an in-depth knowledge of negotiations of clinical trials agreements.
- Demonstrates strong understanding of regulatory and legal issues pertinent to clinical development.
- Demonstrates an understanding of the regulatory implications of contracts as related to clinical research.
- This role must be able to interact on high level with the clinical teams, and project management to provide oversight of negotiations of CTA and clinical budgets.
- Completes tasks and projects under minimal to no supervision.
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/clinical finance
- Competent in computer skills (Microsoft Office including Excel, Word and PowerPoint)
- Relevant experience typically includes contract language and budget negotiation, and application of project management principles.
- Global Site Contracting experience a plus.
- Skilled at project management, able to meet deadlines on multiple concurrent projects and work collaboratively with and through others.
- Demonstrates patience and is able to break down complex information into digestible pieces.
- Able to work in a rapidly changing environment with a high tolerance for ambiguity.
- Aptitude to thrive in a fast-paced, changing environment while producing quality work under time constraint.
- Ability to analyze situations from organizational, departmental perspective (ie considers strategy, culture, structure, systems, people, processes and planning).
- Ability to work effectively in a team environment and creatively solve problems.
- Must exhibit a positive attitude, a respect for others, a results-oriented approach and ability to work independently as well as collectively.
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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 email@example.com 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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