Job Details

Senior Director – Clinical Research & Development, Counsel page is loaded## Senior Director – Clinical Research & Development, Counselremote type: Hybrid-San Diegolocations: San Diego, CAtime type: Full timeposted on: Posted 3 Days Agojob requisition id: JR000479Crinetics 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 with specialized expertise in GxP compliance, contract manufacturing, and regulatory quality matters to support our global research, development, and manufacturing operations. This role will provide strategic legal counsel not only for clinical trials, but also for activities involving contract manufacturing, quality systems, and post-approval compliance. The attorney will partner closely with Quality, Regulatory, 90, and Clinical Operations teams to address operational and compliance risks, assist with regulatory inspections and inquiries, and support governance and oversight of quality-related processes. This position will play a key role in enabling compliant, efficient, and scientifically rigorous operations across the product lifecycle.This position will be a remote position with the ability to attend critical meetings in San Diego, California as needed.**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 Clinical Trial execution, including 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 all aspects of clinical trial execution and associated agreements, e.g., DPIA, ICF, study drug importation and supply, etc. - (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.* Provide legal guidance on contract manufacturing issues, including quality agreements, supply arrangements, and related operational matters.* Participate in governance and committee meetings focused on internal quality metrics, operational oversight, and site or project reviews.* Collaborate with Quality and Regulatory teams to develop corrective and preventive action plans (CAPAs) and formal responses following regulatory inspections, observations, or inquiries.* Assist in developing materials for regulatory meetings and preparing teams participating in such meetings.* Provide guidance on product quality incidents and post-marketing reporting obligations and actions.* Work cross functionally with Quality, Regulatory, and other stakeholders to advise on and support process and systems improvements, including development of global quality policies and training materials.* Draft and edit written reports, presentations, and other communications for internal and external audiences related to regulatory and GxP compliance.* Monitor the external legal and regulatory environment, advising internal stakeholders on emerging GxP and quality-related policy developments.* 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.* Oversee policies and procedures for the law group, and design policies for cross functional legal departments as they pertain to research and development.* Other duties as assigned.**Education and Experience:**Required:For this position, we are seeking an attorney with the following qualifications:* JD required, must be licensed and currently in good standing to practice law in one or more jurisdictions.* Must have at least 13 years of providing direct legal support for pharmaceutical/biotechnology clinical trials.* Must be able to work global working hours when necessary and appreciate that patients are waiting.* Must have significant knowledge of the 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 governing the research and development of human therapeutics.* Must have significant transactional experience involving clinical development programs, data sharing arrangements, clinical supply arrangements, and complex research collaborations.* Excellent verbal and written communication skills, awareness, and ability to engage with others of diverse backgrounds.* Excellent judgment and superior client-relations skills, and the organizational savvy to effectively collaborate with and influence multidisciplinary, diverse and global clients and colleagues.* Ability to deliver clear, concise, and practical advice regarding challenging legal issues to legal and non-legal colleagues, including senior management.* Ability to prioritize and work with agility across multiple projects.* Ability to work both in a team and independently.* Aptitude and interest to learn the scientific/technical side of the business.* Comfortable with getting outside of one's comfort zone and stepping into new areas of practice or business.* High degree of business acumen and people acumen/insights, and ability to influence business leaders at all levels.**Physical Demands and Work Environment:**Physical Activities: On a continuous basis, sit at desk for a long period of time; intermittently answer telephone and write or use a keyboard to communicate through written means. Some walking and lifting up to 25 lbs. may be required. The noise level in the work environment is typically low to moderate. The physical demands described above are representative of those that must be met by an employee to successfully perform the essential functions and responsibilities of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions#J-18808-Ljbffr