Senior Director, Clinical Research and Development, Counsel

4 weeks ago

San Diego, United States Crinetics Pharmaceuticals, Inc. Full time

Senior Director, Clinical Research and Development, Counsel

Categories: Legal

Crinetics is a pharmaceutical company based in San Diego, California, developing much-needed therapies for people with endocrine diseases and endocrine-related tumors. 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 a robust preclinical and clinical development pipeline. 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. Join our team as we transform the lives of others.

Position Summary:

The Crinetics R&D Law Group is seeking an experienced R&D attorney to support our ongoing and upcoming clinical trials. As a partner and key business strategist, this individual will have deep experience supporting global clinical trials, complex transactional support and providing regulatory advice to support global strategies and activities related to product research and development.

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 by developing and executing a variety of contract templates in support of the R&D functions, drafting, negotiating and executing research agreements, 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. The individual will also be responsible for providing strategic advice on legal topics during contract negotiation.

This position will be a hybrid position based in San Diego, California. Relocation benefits are available for this posting.

Essential Job Functions and Responsibilities:

Key responsibilities will include but will not be limited to:

* Provide legal advice, education, and actively resolve legal issues related to the following:
* Clinical Trial Expertise: GxP compliance, diversity in clinical trials, subject recruitment and retention, decentralized trials, patient safety and pharmacovigilance, informed consent, and research privacy, etc.
* Clinical Trial Agreement Execution:
* (a) Lead the direct negotiation of clinical trial agreements and provide oversight of the applicable amendments and site level negotiation process to ensure ethical, fair and compliant practices are followed when developing, negotiating and executing clinical agreements.
* (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. Build a partnership with site contract team, and lead discussions to resolve and finalize contracts in an expedited manner.


* Clinical Trial Operations Support: Identifying and eliminating any friction or potential inefficiencies in supporting Crinetics global clinical trial operations by working directly with clinical study investigators and study sites as well as with CROs; Improving the development and execution process of contracts and budgets in collaboration with internal and CRO partners.


* Proactively identify and address legal issues, foster trusted relationships with client groups, advise leaders in the research and development and medical affairs organizations and serve as a standing or ad hoc member of business teams.
* Consult and collaborate with internal and external stakeholders and subject matter experts to support the above activities, including IP, transactional, privacy and product attorneys, as well as business leadership, regulatory experts, etc.
* Translate business needs into strategic initiatives and drive quantifiable outcomes.
* Focus on immediate and short-term (

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