Associate Director, Clinical Contracts
2 months ago
Eikon Therapeutics is a new biopharmaceutical company employing revolutionary technology at the intersection of chemistry, engineering, computation, and biology to discover novel treatments for life-threatening diseases. Eikon’s discovery platform is built on groundbreaking innovations from its founders (Nobel Prize, 2014), culminating in the creation of microscopes which enable real time, molecular-resolution measurements of protein movement in living cells, thereby unlocking otherwise intractable classes of proteins as drug targets.
Position
The Associate Director of Clinical Contracts will be an integral part of Eikon’s growing legal team. They will support the Company by managing the negotiation of a range of complex agreements necessary for the conduct of global clinical trials by Eikon. This role will focus on the negotiation of Clinical Trial Agreements (CTAs) and include the oversight of third-party global contract negotiation resources under a Functional Service Provider model (FSP). The Associate Director of Clinical Contracts may also support non-clinical contracting across various other departments as needed. This role will have deep support when needed (both internally and via third party resources), but also the ability to work autonomously and drive decision-making. In addition, there may be opportunities to support other non-contracting related projects where there is interest and need, such as helping to develop, implement, and train internally on policies and procedures, such as those related to healthcare compliance and data privacy. This role will report to the Director of Clinical Contracts and will be positioned to collaborate across multiple functions.
Work Location: Hybrid/Flexible - this role is considered an on-site role but does allow for remote work from time to time, depending on business needs. Candidates can work in either our Hayward, CA, New York, NY, or Jersey City, NJ office.
About You
You are a strong conversationalist, able to communicate risks and suggest solutions, prioritize business requests appropriately, excel at working in a fast-paced environment with time-sensitive deadlines, are result-oriented, process-driven, and consistently deliver excellence in your work. Using common and good business sense with attention to detail, you will seamlessly prioritize and track contract requests and projects, determine the root cause of challenges and embrace this dynamic growth opportunity.
What You’ll Do
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. Enjoy taking on new challenges with a knowledgeable (and fun) team to support you along the way.Qualifications
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.At Eikon, employee compensation also includes bonus and equity compensation, in addition to several generous benefit programs, including:
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-siteThe expected salary range for this role is $174,000 to $190,000 depending on skills, competency, and the market demand for your expertise.
Eikon is proud to be an equal opportunity employer and will consider all qualified applicants for employment.
In accordance with the Company’s duty to provide and maintain a safe workplace, the Company requires all employees to be Fully Vaccinated with one of the FDA approved COVID-19 vaccines, which includes those vaccines that have received the FDA’s emergency use authorization. You will be expected to be Fully Vaccinated as of your Start Date. If you believe that you are exempt from this requirement under an applicable law or regulations, including Americans with Disabilities Act and California’s Fair Employment and Housing Act, you will need to contact the Company’s Human Resources group. For purposes of this section, Fully Vaccinated means (i) the completion of the vaccination regimen as approved by the FDA (by way of example, 2 doses of the Pfizer or Moderna vaccine and 1 dose of the Johnson and Johnson vaccine), and (ii) timely receiving booster vaccination, as recommended by the Centers for Disease Control and Prevention.
We are currently not accepting any new third-party agencies or firms at this time. Please do not forward unsolicited agency resumes to our website, employees or Human Resources. Eikon Therapeutics will not pay fees to any third-party agency or firm associated with unsolicited resumes.
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