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 will play a crucial role in Eikon's legal team, focusing on the negotiation of Clinical Trial Agreements (CTAs) and overseeing third-party global contract negotiation resources. This position requires a blend of autonomy and collaboration, supporting both clinical and non-clinical contracting needs while ensuring compliance with regulations. The role also involves contributing to policy development and training related to healthcare compliance and data privacy.

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.

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