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 remote role supports Research and Development, Clinical Operations, Clinical Research, and Medical Affairs by drafting and negotiating research agreements, developing contract templates, and addressing operational and compliance risks across the product lifecycle.

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 direct negotiation of clinical trial agreements, oversee amendments and site-level negotiations to ensure ethical, fair, and compliant practices; coordinate with sites on DPIA, ICF, and study drug importation and supply.
• Collaborate with study sites and Clinical Trial Operations to ensure timely agreement execution; build partnerships with site contract teams to expedite contracts.
• Support Clinical Trial Operations by identifying inefficiencies and improving contract and budget processes with internal teams and CRO partners.
• Participate in governance and committee meetings focused on quality metrics, operational oversight, and site or project reviews.
• Collaborate with Quality and Regulatory to develop CAPAs and responses following inspections or inquiries.
• Develop materials for regulatory meetings and prepare teams for such meetings.
• Provide guidance on product quality incidents and post-marketing reporting obligations.
• Advise on process and systems improvements, including global quality policies and training materials; work with Quality, Regulatory, and other stakeholders.
• Draft and edit reports, presentations, and communications related to regulatory and GxP compliance.
• Monitor external regulatory environment and advise on 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 and subject matter experts (IP, transactional, privacy, product attorneys, regulatory experts, etc.).
• Translate business needs into strategic initiatives and drive measurable outcomes.
• Oversee and design policies for cross-functional legal departments related to research and development.
• Perform 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 as needed; understands that patients are waiting.
• Significant knowledge of human subject protection laws, FD&C Act and related regulations, US and global privacy laws, and laws governing the research and development of human therapeutics.
• Significant transactional experience involving clinical development programs, data sharing arrangements, and complex research collaborations.
• Excellent verbal and written communication, judgment, and client-relations skills; ability to engage diverse stakeholders.
• Ability to deliver clear, practical legal advice to both legal and non-legal colleagues, including senior management.
• Ability to prioritize across multiple projects and work both independently and in a team.
• Aptitude to learn the scientific/technical aspects of the business; comfortable exploring new areas of practice.
• Strong business acumen and ability to influence business leaders at all levels.

Skills

• Regulatory and GxP compliance knowledge
• Clinical trial agreements and contracting
• Quality systems and CAPA development
• Regulatory communications and inspections
• Cross-functional collaboration
• Legal writing and presentations

Education

• JD; bar admission in good standing

Additional Requirements

• Physical Demands and Work Environment: None beyond standard office-based work; some travel may be required.
• Travel: Up to 10% of time; quarterly meetings at Crinetics‚Äô headquarters in San Diego and other critical meetings as needed.