Associate Director, Clinical Contracts

$174,000 - $190,000/Yr

Eikon Therapeutics - Hayward, CA

Full-time - Mid Level

Hybrid - Hayward, CA

Professional, Scientific, and Technical Services

About the position

The Associate Director of Clinical Contracts at Eikon Therapeutics will play a crucial role in managing the negotiation of complex agreements necessary for global clinical trials. This position involves overseeing Clinical Trial Agreements (CTAs) and collaborating with various departments to ensure compliance and effective contract management. The role requires both independent decision-making and teamwork, with opportunities to contribute to policy development and process improvements.

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 (JD).
• 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 healthcare compliance and data privacy training.
• Familiarity with contract lifecycle management (CLM) systems.

Benefits

• 401k plan with company matching
• Medical (premiums covered by Eikon at 95%), dental and 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