Associate Director, EX US Clinical Site Contracts

Revolution Medicines•Redwood City, CA

8d•Hybrid

About The Position

Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) Inhibitors designed to suppress diverse oncogenic variants of RAS proteins, and RAS Companion Inhibitors for use in combination treatment strategies. As a new member of the Revolution Medicines team, you will join other outstanding Revolutionaries in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway. The Opportunity: Revolution Medicines is seeking a motivated Associate Director of Global Site Contracts who will be responsible for reviewing and managing EX US contracts and budget escalations across multiple agreement types. This role will collaborate with internal and external stakeholders across multiple countries, with the goal of supporting timely contract execution and delivery of the site activation strategy. Additional responsibilities include leading, developing, and maintaining negotiation parameter guidance documents at both the country and site levels, as well as reviewing and approving Fair Market Value (FMV) assessments.

Requirements

BA/BS in Medical or Life Sciences or equivalent, with 10+ years of clinical contracts and budget experience in the pharmaceutical or biotechnology industry.
Must have Global Phase 1–3 clinical site agreement and budget negotiation experience.
Strong Oncology experience required.
Must demonstrate clear understanding of EX US contracting and budgeting process.
Must have in-depth knowledge of country-specific contract terms, regulatory requirements, and use, where applicable, of regional clinical site agreement templates.
Excellent organizational and time management skills along with strong attention to detail.
With proven ability to handle multiple tasks efficiently and effectively.
Excellent computer skills including advanced knowledge in MS Excel, Word, PowerPoint and Outlook.
Must be a self-starter who works with minimal supervision.
Works effectively in a solution cross-functional environment.
Excellent communication skills, (verbal and written), and critical thinking skills.
High sense of accountability/urgency.
Analytical skills with a data driven approach to planning, executing, and problem solving.
Extensive experience in global clinical trial operations.
Ability to travel to the corporate office quarterly.

Nice To Haves

Grant Plan or Grant Manager experience.
J.D. a plus.
Smartsheet experience.
Leadership and management skills.

Responsibilities

Understanding of the overall clinical development paradigm, especially around clinical study operations and have global or regional experience.
Assume the management and oversight of direct reports, as well as any other duties that are deemed a need of the business.
Effectively work with the legal and finance teams as well as external partners to ensure clinical agreements comply with the business’s best practices and relevant country regulations.
Ensure all deliverables of the site contracts group are aligned with defined study timelines provided by the clinical operations team.
Ensure team’s work complies with established practices, policies and processes, and any regulatory or other requirements.
Provide clear guidance on all clinical contracting issues throughout the contracting process.
Responsible for overseeing and ensuring a smooth execution and oversight of the entire lifecycle of site contracts.
Deep understanding of the end-to-end clinical development paradigm, with expertise in clinical study operations and experience operating in global and/or regional environments.
Assist in development and implementation of contract management policies and procedures.
Develop, implement, manage and ensure completion of site contracts develop and cultivate excellent internal cross-departmental and external service provider relationships to enable advancement of clinical development programs.
Assist in escalations to achieve final scopes of work, budgets, and payment schedules, with input from cross-functional stakeholders, for service providers.
Evaluate and monitor contract performance to ensure compliance and mitigate risks.
Liaise with legal counsel to address complex contract matters.
Extensive experience in site and CRO management, to ensure contracts are executed on a timely basis.
Assist in the development, improvement and implementation of processes and tools related to outsourcing and governance activities.
With the support of RevMed’s legal counsel, manage the contract negotiation process.
Support and manage general and departmental ad hoc projects as required.
Participate in corporate strategic initiatives.
Monitor shifts in industry trends and technologies.
Network with vendors and sites to stay on top of best practices for efficient trial execution by stage of development
Ensure FMV prices are obtained, savings objectives are met and ensure the best interests of RevMed are safeguarded.
Promote effective communication and transparency in our CRO/service provider interactions.
Initiate, author or otherwise contribute to standard operating procedure (SOP) development, implementation and training.