Associate Director, Development Business Operations - ISR/Collaborative

Employer
Kite Pharma
Location
Foster City, CA, United States
Posted
Oct 18, 2019
Ref
R0008349
Required Education
Bachelors Degree
Position Type
Full time
Gilead Sciences, Inc. is a research-based biopharmaceutical 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. Gilead's therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.

Specific Responsibilities:

This position is located at Gilead Sciences' Corporate Headquarters in Foster City - San Francisco Bay Area, California.

Ideal candidate will have a demonstrated track record of success in managing and developing multiple direct reports on a high-performing team, including peer managers, in order to maximize their capability and further their development while maximizing their contributions and value toward operational delivery. The candidate will also have a track record of working collaboratively within a matrix environment with other cross-functional groups to proactively foster and ensure continuous improvement and operational excellence.

Position will be accountable for drafting, negotiating, and reviewing complex global investigator-sponsored research contracts, collaborative research contracts, and related ancillary contracts (collectively, "ISR/CO" contracts), including both language and budgets, supervising, coaching, and evaluating staff within the ISR/CO contracting functional area, as well as managing one or more Functional Service Providers (FSPs) performing assigned contracting activities. Will require oversight of contracts for multiple ISR/CO programs within Gilead Medical Affairs and Clinical Research departments, ensuring adequate level of staff to complete contracts in an accurate, consistent, and timely manner. Must coordinate with Gilead Clinical Operations, Medical Affairs, Clinical Research, Pharmacovigilance, Legal and/or Business Conduct departments to manage and complete the ISR/CO contracting process throughout the duration of research. Responds and resolves complex issues associated with both domestic and international contracting with support from more senior staff and Gilead Legal department. Ideal candidate will have demonstrated success in working collaboratively with multiple stakeholders, especially senior Development Operations management.

Essential Functions:
  • Leads or manages members of a functional team within Development Business Operations department.
  • Manages the day-to-day activities of multiple areas in complex clinical contracts and finance processes.
  • Develops strategy for, and provides oversight of, activities necessary for the development and execution of ISR/CO contracts for non-Gilead sponsored research.
  • Focuses on ISR/CO contracting, fair market value (FMV) compliance of ISR/CO contracts, and financial accountability as it relates to FSP management.
  • Manages staff grade 29/30 and below.
  • Participates in establishing departmental and cross-functional policies and procedures.
  • Manages contracting activities for multiple research projects conducted by third parties with support from Gilead, ensuring that there is adequate staff with the skills to complete contracts accurately, consistently, and in a timely manner.
  • Provides information to Senior Management on contracting, fair market value (FMV), and finance issues.
  • Assists staff working on contracts in resolving complex issues relating to contract negotiation or management.
  • Trains staff in contract budgeting, development, and administration.
  • Develops appropriate job aides and tracking tools.
  • Manages vendor relationship with FSP in conjunction with Vendor Relationship Management function.
  • With the support of internal customers and Gilead Legal department, manages the contracting negotiation process, especially in more complex, or high value contracts.
  • Leads contracting life cycle management process related to ISR/CO contracts.
  • Demonstrates excellent analytical, verbal, written, and interpersonal communication skills.
  • Demonstrates applicable knowledge of clinical and non-clinical research functions.
  • Demonstrates an understanding of regulatory and legal issues pertinent to ISR/CO compliance and contracting.
  • Demonstrates ability to interact on an advanced level with Gilead Medical Affairs and Clinical Research teams, FSP, Clinical Pricing, and Clinical Payments team to provide oversight of associated budgets and related contractual terms.
  • Demonstrates a basic understanding of the regulatory implications of contracts as related to ISR/CO research, including Good Clinical Practices (GCPs).
  • Completes tasks and projects under minimal supervision.
  • Evaluates contracting and budget changes requested within ISR/CO contracts and identifies business and/or legal risks in order to manage the issue to resolution by proposing and providing alternative solutions to Gilead Legal or senior management.
  • Demonstrates ability to make critical decisions related to projects and associated tasks.
  • Demonstrates leadership skills while working in a fast-paced and changing environment.
  • Travel may be required.

Knowledge, Experience and Skills:
  • 10 years of experience with a BA in a relevant discipline
  • 8 years of experience with a MS in a relevant discipline
  • Relevant experience typically includes contract language and budget negotiation, and application of project management principles
  • 6 years of experience managing a team of 3 or more
  • MBA or JD preferred
  • PMP or CPSM certification a plus
  • Competent in computer skills (Microsoft Office including Excel, Word and PowerPoint)
  • Experience with implementing a contract management system a plus
  • Global ISR/CO contracting experience a plus
  • Advanced knowledge of financial terms and budgeting
  • Development of End User Documentation Tools a plus
  • Skilled at development and delivering staff training


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