Sr. Contracts Manager, R&D

at  CRINETICS PHARMACEUTICALS

Crinetics is a pharmaceutical company based in San Diego, California that develops much-needed therapies for people with rare endocrine diseases. We were founded by a dedicated team of scientists with the simple belief that better therapies developed from rigorous innovation can lead to better lives. Our work continues to make a real difference in the lives of patients. We have a prolific discovery engine and robust pipeline across preclinical and clinical development. We are driven by science with a patient-centric and team-oriented culture. This is an exciting time to join Crinetics as we shape our organization into the world’s premier fully integrated endocrine company from discovery to patients. Come join our team as we transform the lives of others.

POSITION SUMMARY:

The Crinetics R&D Law Group is seeking an experienced R&D paralegal to support our ongoing and upcoming clinical trials. This individual will have deep experience supporting global clinical trial and related contracts necessary for product research and development. This position is expected to oversee a high volume of contracts and to collaborate within the Legal team and a variety of departments on to ensure the contracts are completed in a timely manner and in compliance with our policies.
As a member of the R&D Law Group, this individual will primarily support Crinetics’ Research and Development, Clinical Operations, Clinical Research, CMC, and Medical Affairs functions. This person will work independently on a wide variety of contracts, including negotiation, drafting and review of clinical study-related agreements in support of the R&D functions, including without limitation, Clinical Trial Agreements for US and ex-US clinical research sites, CMC research and development and commercial supply agreements, agreements for Investigator Initiated Studies, and other life sciences R&D agreements.

EDUCATION AND EXPERIENCE:

Required:

• Paralegal or bachelor’s degree in a related field is required.
• Minimum 12 years of providing direct legal support for pharmaceutical/biotechnology clinical trials.
• Clinical Trial Agreement Excellence: (a) Lead the direct negotiation of clinical trial agreements and provide oversight of the applicable amendments and site level negotiation using approved playbook and clause libraries; (b) Work in close collaboration with study sites as well as the Clinical Trial Operations team to ensure clinical study agreement execution within the timelines and in an efficient manner and (c) Partner with site contract team to efficiently resolve and finalize contracts with an acute appreciation that patients are waiting.
• Excellent written and verbal communication, project coordination, and interpersonal skills.
• Must have working knowledge of human subject protection laws, Federal Food, Drug and Cosmetic Act and related regulations, US and global privacy laws, and other applicable federal and state laws and appreciate the need to escalate issues governing the research and development of human therapeutics.
• Must have experience involving clinical development programs, data sharing arrangements, clinical supply arrangements, and complex research collaborations.
• Proficient in the use of contract management software, spreadsheets, database and word-processing applications.
• Ability to rapidly establish credibility and relationships with a broad range of individuals.
• Attention to detail and high level of accuracy.

These may include but are not limited to:

• Prepare, review, negotiate and keep track of all important details of an agreement, including key deliverables, milestones, dates, deadlines, and opt-out/negotiation windows, and termination or cancellation requirements.
• Work closely with attorneys, the finance department and business personnel to support the timely initiation, negotiation, review, execution, and administration of contracts.
• Review, draft and negotiate various service agreements, including but not limited to, Master Service Agreements, Statements of Work, Consulting Agreements, etc.
• Work with the internal client to participate in development of RFPs and proposal reviews and ensure alignment with contract strategies and business objectives as well as ensure all requested contracts provide complete information, including but not limited to, service description, budget, and milestones as applicable.
• Ensure terms and conditions of the contracts align with current guidance and/or policy; review, draft, and document suggested language changes, and oversee resolution of all proposed changes to agreements.
• Identify and resolve routine and moderately complex legal matters in area of responsibility with minimal supervision.
• Develop knowledge of Crinetics R&D business and quickly identify issues for appropriate escalation within the business, finance, compliance or legal.
• Facilitate contract actions and processes independently and effectively.
• Responsible for the reporting and analytics function of the CLM tool to provide key performance indicators (KPI) of the contract lifecycle.
• Liaise with procurement and Finance to ensure appropriate and required information is communicated between Finance, procurement and Legal.
• Act as point person for all business users’ queries relating to submission of their contract requests.
• Coordinate execution of approved documents, update status in the system of record and assist with the distribution of documents, both internally and externally.
• Perform special tasks and assignments as required by management.