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 professionals in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.
The Opportunity:
This is a unique opportunity for an experienced clinical contracts professional who possesses strong clinical contract and budget negotiation expertise in Phase I-III clinical trials. As the Associate Director, reporting to the Director of Clinical Vendor Outsourcing, you will be responsible for building a team that will ensure all deliverables of the site contracts group are in alignment with defined study timelines provided by the clinical operations team. Provide clear guidance on all clinical contracting issues throughout the contracting process. Effectively manage the drafting, review, and negotiation process of clinical contracts. 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. Specifically, you will be responsible for:
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Management and oversight of the review, drafting, negotiation and tracking of the various clinical agreements including MSAs, CTAs, ICTAs, CNFs and amendment agreements.
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Setting up clinical contracting processes that will ensure that clinical contracts are executed in a timely manner, to ensure clinical trials are not delayed.
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Working closely with the clinical operations study team, legal and finance to resolve any contract issues to improve the site contracts cycles.
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Partnering closely with clinical operations, legal, finance and other functional departments to understand the business priorities to support the effective delivery of negotiated contracts.
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End-to-end management of the clinical trial agreement (CTA) process and strategy for global, multi-site clinical trials
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Participating in corporate strategic initiatives.
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Providing contract support at several stages of clinical trials including start-up, maintenance, and close-out
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Working with legal to develop playbooks to assist with escalations in site contracts.
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Collaborate regularly with Legal/Finance regarding contract execution and assessment of risk.
Required Experience, Skills, and Education:
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BS/MS Degree in a scientific discipline with a minimum of 10 years of clinical contracts and budget experience in the pharmaceutical or biotech industry,
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Demonstrated experience in the authoring, negotiation and management of clinical trial agreements, master service agreements and other governing documents.
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Knowledge of relevant local regulations
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FMV experience, working knowledge of Grant Plan
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Advanced knowledge of Microsoft Word, Excel, and PowerPoint
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Leadership and management skills
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Experience in site and CRO management, to ensure contracts are executed on a timely basis.
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Strong working knowledge of FDA Regulations, ICH Guidelines and GCPs governing the conduct of clinical trials.
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Thrives in a collaborative team setting and is driven by a desire to deploy innovative approaches and technologies in a high-energy environment.
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Excellent written and verbal communication skills.
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Demonstrated ability to multi-task, prioritize options, anticipate challenges, and execute goals as a member of an interdisciplinary team is extremely important.
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Minimal travel required.
Preferred Skills:
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Oncology experience.
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oncology drug development with experience in clinical contract negotiations.
The expected salary range for this role is $175,000 to $210,000. An individual’s position within the range may be influenced by multiple factors, including skills and experience in role, overall performance, individual impact and contributions, tenure, and market dynamics. Base salary is one part of the overall total rewards program at RevMed, which includes competitive cash compensation, robust equity awards, strong benefits, and significant learning and development opportunities.
Revolution Medicines is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital status, medical condition, and veteran status.
Revolution Medicines takes protection and security of personal data very seriously and respects your right to privacy while using our website and when contacting us by email or phone. We will only collect, process and use any personal data that you provide to us in accordance with our CCPA Notice and Privacy Policy. For additional information, please contact privacy@revmed.com.
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