Senior Associate, Development Business Operations, Site Contracts

Employer
Kite Pharma
Location
Foster City, CA, United States
Posted
Sep 18, 2019
Ref
R0009640
Required Education
Associate Degree
Position Type
Full time
Job Description

Senior Associate, Development Business Operations, Site Contracts

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 the FSP provides 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 lead 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 experience in working reciprocally with leadership and senior Development Business Operations management.

This role does 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 Contracts Process to ensure efficient delivery of fully executed contracts.

Handles 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 handle 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.

With the support of internal customers and the legal department, within the contract negotiation process.

Management of contract life cycle process for assigned Clinical Trial Study.

Demonstrates excellent verbal, and written communication skills.

This role demonstrates an in-depth knowledge of negotiations of clinical trials agreements.

Demonstrates strong knowledge of regulatory and legal issues pertinent to clinical development.

Demonstrates knowledge 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 direction of negotiations of CTA and clinical budgets.

Completes tasks and projects under minimal to no supervision.

Knowledge, Experience and Skills:

6+ years of experience with a BA with contract negotiation and/clinical finance experience

4+ years of experience with a MS/MBA with contract negotiation and/clinical finance experience

Competent in computer skills (Microsoft Office including Excel, Word and PowerPoint)

Significant 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 reciprocally with and through others.

Ability to break down complex information into digestible pieces.

Aptitude to thrive in a fast-paced, changing environment while producing quality work under time constraint.

Ability to analyze situations from the company and departmental perspective (ie considers strategy, culture, structure, systems, people, processes and planning).

Ability to work effectively in a team environment and creatively resolve problems.

Must exhibit a positive attitude, a respect for others, and ability to work independently as well as collectively.

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