Clinical Outsourcing

2 months ago

Foster City, United States ACL Digital Full time

Job Title: Clinical Contracts & Finance Manager - III

Location: Foster city, CA OR Santa Monica, CA (Hybrid)

Duration: 12+ Months


This is an onsite position 3 days a week.

Candidate can be based in either FC or NJ or Santa Monica locations


Client is a research-based biopharmaceutical company founded in 1987. Together we deliver life-saving therapies to patients in need. With the commitment and drive you bring to the workplace every day, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives. Our worldwide staff is a close community where you can see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through ongoing development. As part of our rapidly growing science-driven organization, colleagues at Gilead are revolutionizing healthcare by bringing urgently needed medicines to patients in the areas of Virology, Inflammation and Oncology conditions. We are proud to have some of the most talented colleagues from across the research, healthcare, pharmaceutical, biotechnology & business sectors, working together and supporting each other to help make a real difference to the lives of patients.


Gilead Sciences is currently seeking an industry leader for Sr. Manager, R&D Outsourcing within our Development Business Operations department.

The Sr. Manager will have the opportunity to provide category management, sourcing and contracting expertise in clinical outsourcing of global Phase 1b-Phase 3 clinical trials.

The Sr. Manager will lead the entire life cycle including vendor selection, RFI, RFP, vendor selection decision, contracting, monitoring performance, change orders and ensuring proper closeout of clinical agreements, with a focus on Clinical Research Organizations (CRO).

The position will have the opportunity to work in a matrix environment and regularly collaborate with Senior Management and cross functional teams.


The core responsibilities and skills required for this position include but is not limited to:

Delivery Excellence

• Develops global clinical development vendor strategy for a program or therapeutic area with a focus on Cell Therapy

• Manages contract and sourcing activities for Phase 1b-3 clinical development programs providing consistent customer service and delivering quantitative value through cost savings and transformation/innovation

• Develops and implements sourcing strategies to support given scope

• Manages the contract negotiation process across the entire life cycle including RFI, vendor identification, RFP, vendor selection decision, contracting negotiation, performance monitoring, change orders, and ensures proper closeout of agreements to maximize contract value and achieve target savings

• Ensure the vendor selection process is compliant by managing risks through benchmarking, rate negotiations, implementing the sourcing strategy, collaborating with cross functional teams such as Compliance, Legal and Regulatory

• Collaborates with internal customers in vendor bidding and proposal development (RFP creation and analysis)

• Partners with internal customers to develop study specifications and leverages benchmarking tools as appropriate

• Translates business requirements into vendor capabilities and develops recommendations for vendor selection for a program or therapeutic area

• Is an SME in resolving complex issues relating to contract negotiation and management

• Oversees the identification, selection and management of global external service providers

• Leads Vendor bid defense meetings

• Manages the contract negotiation process for complex or high value contracts

• Demonstrates strong understanding of regulatory and legal issues pertinent to clinical development


Capabilities and Requirements

• Experience in providing thought leadership and consistent customer service

• Expertise in the end-to-end sourcing and contracting process, including RFx, contract negotiation and management

• Demonstrates an in-depth knowledge of the clinical research process and the regulatory environment across functions

• Demonstrated leadership skills while working in fast paced and changing environment

• Financial acumen to review, analyze and understand cost drivers of complex budgets

• Legal, clinical operations and regulatory acumen

• Travel may be required


Knowledge, Experience and Skills:

• Relevant experience with a BA or MS in a relevant discipline

• MBA or JD preferred

• PMP/CPSM certification or equivalent a plus

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