Associate Director, Trial Master File

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. Crinetics is known for its inclusive workplace culture. We are also a dog-friendly workplace. 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:

In alignment with strategic direction, the Associate Director, TMF will provide leadership and operational oversight of the Trial Master File (TMF) function to ensure inspection-ready, high-quality clinical documentation across the organization. This role will partner cross-functionally with Quality Assurance and IT to optimize TMF processes, systems, and compliance. The Associate Director will lead a team responsible for day-to-day TMF management, metrics, and reporting, while driving continuous improvement initiatives and ensuring adherence to ICH GCP, Good Documentation Practices (GDocP), and all applicable regulations. The Associate Director will also partner with cross-functional leads to promote a culture of inspection readiness across the clinical trial portfolio.

Essential Job Functions and Responsibilities:

These may include but are not limited to:

• Provide leadership and oversight of TMF operations, ensuring inspection readiness and compliance with global regulations and internal standards.
• Manage and mentor TMF staff, fostering a culture of accountability, quality, and professional development.
• Oversee and optimize use of Veeva Vault eTMF and ensure alignment with business needs and best practices.
• Partner with Veeva Managed Services and Clinical Systems Manager to resolve issues, implement system enhancements, and ensure operational excellence.
• Lead TMF metrics and reporting, including completeness, timeliness, and quality, providing transparency to senior leadership.
• Serve as a subject matter expert for ICH GCP, GDocP, CDISC TMF Reference Model (formerly DIA TMF Reference Model), and global clinical trial regulations.
• Support with audits and regulatory inspections, including preparation, backroom support, and follow-up activities.
• Support CAPA management: drafting, implementation, tracking, and closure for TMF related quality events.
• Support authoring, reviewing, and maintaining SOPs, Work Instructions, and training materials, plans related to the TMF.
• Support in maintaining and performing change control on company TMF Content Map.
• Drive change management initiatives to improve TMF processes, systems, and culture in a matrixed environment.
• Partner with stakeholders on process improvement projects and conduct TMF training across clinical and study teams.
• Ensure proper TMF configuration and adoption that may have impact on adjacent Veeva Clinical Suite applications such as, CTMS, Site Connect, Study Training, Study Start-up.
• Collaborate cross-functionally to ensure TMF expectations are clearly defined, implemented, and monitored throughout study lifecycles.
• Other duties as assigned.

Education and Experience:

Required:

• Bachelor’s degree in Life Sciences, Healthcare, or related field required; advanced degree preferred.
• Minimum 10 years of experience in TMF Operations within the pharmaceutical, biotech, or CRO industry.
• A minimum of 7 years in a supervisory role
• Demonstrated people management experience, including performance management and team development.
• Proven expertise with Veeva Vault eTMF
• Experience working with Veeva Managed Services to implement improvements and resolve issues.
• Strong background in TMF metrics and reporting.
• Hands-on experience in audits/inspections (e.g., FDA, EMA, MHRA).
• Experience in CAPA lifecycle management.
• Proficiency in SOP and WI development, training, and implementation.
• Strong knowledge of ICH GCP, GDocP, global clinical trial regulations, and CDISC TMF Reference Model.
• Demonstrated ability to lead change management initiatives and influence in a matrixed environment.
• Strong interpersonal and communication skills, with the ability to partner effectively across functions and levels.
• Excellent organizational, analytical, and problem-solving skills with attention to detail.

Preferred:

• Experience with working with Veeva CTMS, Site Connect, Study Training, Study Start-up in relation to TMF process flows.
• Experience in process transformation and implementation of tools to streamline TMF operations.
• Familiarity with risk-based TMF management approaches.
• Experience in global/multi-regional clinical trial environments.
• Strong project management skills and ability to balance multiple priorities in a fast-paced environment.

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 and responsibilities.

Laboratory Activities (if applicable): Biology and chemical laboratory environment experience needed. Environmental health and safety requirements also apply.

Travel:

You may be required to travel for up to 5% of your time.

Equal Opportunity Employer:

Crinetics is proud to be an Equal Opportunity Employer. We provide equal employment opportunities to all employees and employment applicants without regard to unlawful considerations of sex, sexual orientation, gender (including gender identity and/or expression), pregnancy, race, color, creed, national or ethnic origin, citizenship status, religion or similar philosophical beliefs, disability, marital and civil union status, age, genetic information, veteran status or any personal attribute or characteristic that is protected by applicable local, state or federal laws.

Salary Range

In addition to your base pay, our total rewards program consists of a discretionary annual target bonus, stock options, ESPP, and 401k match. We also provide top-notch health insurance plans for employees (and their families) to include medical, dental, vision and basic life insurance, 20 days of PTO, 10 paid holidays, and a winter company shutdown.