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Eikon Therapeutics - Hayward, CA

posted 4 months ago

Full-time - Senior
Hybrid - Hayward, CA
Professional, Scientific, and Technical Services

About the position

Eikon Therapeutics is a pioneering biopharmaceutical company that leverages cutting-edge technology at the intersection of chemistry, engineering, computation, and biology to develop innovative treatments for life-threatening diseases. The Associate Director, Contracts Professional will play a crucial role within Eikon's expanding legal team, focusing on the negotiation and management of complex agreements essential for conducting global clinical trials. This position will primarily involve negotiating Clinical Trial Agreements (CTAs) and overseeing third-party global contract negotiation resources under a Functional Service Provider (FSP) model. The role also encompasses support for non-clinical contracting across various departments as needed, providing a unique opportunity to engage in diverse projects beyond contracting, such as developing and implementing internal policies related to healthcare compliance and data privacy. The Associate Director will report directly to the Director of Clinical Contracts and will collaborate with multiple functions within the organization. This hybrid role allows for flexibility, permitting remote work as business needs dictate, with candidates able to work from Eikon's offices in Hayward, CA, New York, NY, or Jersey City, NJ. The ideal candidate will possess strong communication skills, be adept at managing risks, and excel in a fast-paced environment with time-sensitive deadlines. They will be results-oriented, process-driven, and committed to delivering excellence in their work, all while maintaining a keen attention to detail and the ability to prioritize effectively. In this role, the Associate Director will be responsible for overseeing the entire clinical contracts process, from drafting and negotiation to execution. They will work closely with Eikon's Clinical Operations and Study Start-Up teams to ensure that all contracts comply with relevant regulations and accurately reflect the company's needs. Building and maintaining effective relationships with vendors and service providers will be essential, as will monitoring contract performance metrics to ensure compliance and fulfillment of obligations. The Associate Director will also contribute to improving Eikon's contracting processes and its Contract Lifecycle Management (CLM) system, participating in cross-functional projects as necessary.

Responsibilities

  • Develop and manage the oversight and delivery of global clinical site contracts and non-site contracts across the clinical drug development cycle.
  • Manage the clinical contracts process from start to finish, including drafting, negotiation, and execution of agreements.
  • Collaborate with Eikon's Clinical Operations and Study Start Up teams to direct vendor oversight of the management of Functional Service Providers (FSPs) involved in the contracting process.
  • Ensure that all contracts are in compliance with relevant regulations and guidelines, and that they accurately reflect the needs and objectives of the company.
  • Develop and maintain effective relationships with vendors and service providers.
  • Monitor and track contract performance metrics to ensure that clinical contracting support vendors and service providers are meeting their obligations.
  • Work with and foster improvements upon Eikon's contracting process and its CLM system.
  • Contribute to and support cross-functional or departmental projects to improve processes relating to our contracting and clinical procurement process, including those relating to our CLM system.
  • Participate in departmental or other special projects as needed.
  • Work with minimal supervision and exercise independent judgment with the ability to escalate issues when appropriate.

Requirements

  • 10+ years of experience with a BA/BS in a relevant discipline OR 6+ years of experience with a graduate degree.
  • Experience negotiating clinical development contracts in a pharmaceutical/biotech company or university setting.
  • Thorough understanding of clinical operations, including regulatory requirements, data management, and the drug development process.
  • Ability to foster strong relationships with both internal and external partners.
  • Global clinical site contracting experience, including site contracting, site budget negotiation, and fair market value assessment procedures.
  • Strong negotiation skills.
  • Knowledge of the current global and regional trends in clinical outsourcing and contracting.
  • Knowledge of the healthcare compliance landscape and Data Privacy Regulations/Laws (e.g. GDPR, HIPAA).
  • Demonstrated abilities to communicate clearly, and collaborate effectively with leadership, colleagues, and third parties.
  • Demonstrated experience managing and maintaining document databases and/or contract management systems.
  • Excellent project management, prioritization, multi-tasking and negotiation skills.
  • Ability to work and make decisions independently.

Nice-to-haves

  • Experience with Contract Lifecycle Management (CLM) systems.
  • Familiarity with healthcare compliance and data privacy regulations.

Benefits

  • 401(k) matching
  • Medical insurance (premiums covered by Eikon at 95%)
  • Dental insurance (premiums covered by Eikon at 100%)
  • Vision insurance (premiums covered by Eikon at 100%)
  • Mental health and wellness benefits
  • Weeklong summer and winter holiday shutdowns
  • Generous paid time off and holiday policies
  • Life/AD&D Insurance (premiums covered by Eikon at 100%) and optional supplemental employee-paid life/AD&D policies
  • Enhanced parental leave benefit
  • Daily subsidized lunch program when on-site
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