Senior Director, Clinical Research & Development Counsel

Role Summary

The Crinetics R&D Law Group seeks an experienced R&D attorney with specialized expertise in clinical research, GxP compliance, and regulatory quality matters to support global research and development operations. This role supports Research & Development, Clinical Operations, Clinical Research, and Medical Affairs by developing contract templates for R&D activities and drafting, negotiating, and executing research agreements. The attorney collaborates with Clinical Operations, Quality, and Regulatory teams to address operational and compliance risks and support governance of quality-related processes. This position enables compliant, efficient, and scientifically rigorous operations across the product lifecycle. This is a remote position with the ability to attend critical meetings in San Diego, California as needed.

Responsibilities

• Provide legal advice and resolve issues related to Clinical Trial execution, including GxP compliance, trial diversity, recruitment and retention, decentralized trials, patient safety and pharmacovigilance, informed consent, and research privacy.
• Lead negotiation of Clinical Trial Agreements and oversee amendments and site-level negotiations to ensure ethical, fair, and compliant practices; collaborate with study sites to execute agreements within timelines; build partnerships with site contract teams.
• Support Clinical Trial Operations by reducing friction in global clinical trial operations and improving contract/budget development with internal and CRO partners.
• Participate in governance and committee meetings focusing on internal quality metrics and project reviews.
• Collaborate with Quality and Regulatory teams to develop CAPAs and responses following regulatory inspections or inquiries.
• Develop materials for regulatory meetings and prepare teams participating in such meetings.
• Provide guidance on product quality incidents and post-marketing reporting obligations.
• Work cross-functionally to advise on process and system improvements, including global quality policies and training materials.
• Draft and edit written reports, presentations, and communications related to regulatory and GxP compliance.
• Monitor external legal and regulatory environment for emerging GxP and quality-related policy developments.
• Identify and address legal issues, foster relationships with client groups, and serve on business teams as needed.
• Collaborate with internal and external stakeholders, including IP, transactional, privacy, and product attorneys, as well as regulatory experts.
• Translate business needs into strategic initiatives and drive measurable outcomes.
• Oversee policies and procedures for the law group and design policies for cross-functional legal departments in R&D.
• Other duties as assigned.

Qualifications

• JD required; licensed and in good standing to practice law in one or more jurisdictions.
• At least 13 years of direct legal support for pharmaceutical/biotechnology clinical trials.
• Ability to work global hours when necessary and understand that patients are waiting.
• Significant knowledge of human subject protection laws, FDA and related regulations, US/global privacy laws, and other laws governing R&D of human therapeutics.
• Significant transactional experience involving clinical development programs, data sharing arrangements, and complex research collaborations.
• Excellent verbal and written communication skills and ability to engage with diverse stakeholders.
• Strong judgment, client-relations skills, and ability to influence multidisciplinary, global clients and colleagues.
• Ability to deliver clear, practical advice to legal and non-legal colleagues, including senior management.
• Ability to prioritize and work across multiple projects with agility; capable of both team and independent work.
• Aptitude to learn the scientific/technical side of the business; comfortable with new areas of practice or business.
• High business and people acumen with ability to influence leaders at all levels.

Skills

• Regulatory and GxP compliance
• Clinical trial agreements and contract negotiation
• Quality systems and CAPA development
• Regulatory affairs support and inspections
• Cross-functional collaboration
• Strategic initiative development and implementation

Education

• Juris Doctor (JD) degree from an accredited institution; active bar membership in good standing.

Additional Requirements

• Physical Demands and Work Environment: Standard desk work; occasional walking and lifting up to 25 lbs; some laboratory environment considerations may apply.
• Travel: Up to 10% travel; attendance at quarterly meetings at Crinetics‚Äô headquarters and ad hoc meetings as needed.