Associate Director, Clinical Trials Supplies

Crinetics is a pharmaceutical company based in San Diego, California that develops much-needed therapies for people with rare endocrine diseases. 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 robust pipeline across preclinical and clinical development. 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. Come join our team as we transform the lives of others.

Position Summary:

This position will perform strategic, clinical supply management for its development programs (phase 1, 2, 3) and will report to the Director, Clinical Trial Supplies. The Chemistry, Manufacturing and Controls (CMC) team is highly collaborative with a global network of highly qualified Contract-Research Organizations (CROs) and Contract Development and Manufacturing Organizations (CDMOs).

Essential Job Functions and Responsibilities:

These may include but are not limited to:

• Manage contract packaging and distribution vendor operations for Crinetics’ sponsored ongoing and upcoming clinical trials, including budget, timelines, review of specifications, master and executed packaging records, labeling, distribution instructions, logistics, and QP interactions.

• Plan and execute domestic and international distribution of Clinical Trial Materials for all therapeutic programs. Manage inventory at warehouse and site levels including monitoring drug supply usage, use date expiry, drug returns, field transfers, and destruction.

• End-to-end management of IRT systems, from set up to close out.

• Oversee work at CROs, CDMOs, packaging and distribution facilities.

• Integrate cross functional internal and external teams across CMC, clinical operations, regulatory affairs, and quality assurance to deliver clinical trial materials.

• Author global clinical labels, pharmacy manuals, and clinical supplies Standard Operating Procedures.

• Support preparation of regulatory filings (including INDs, IMPDs, NDAs, briefing packages, and other regulatory dossiers).

• Support Quality Assurance with implementation and management of the quality system and compliance activities, including inspections by regulatory agencies and audit functions.

Education and Experience:

• Bachelor's degree with at least 10 years of related clinical trial supply experience with increasing responsibility in biopharmaceutical development with 7 years of supervisory/leadership experience.

• Previous experience in rare diseases /oral solid dosage forms is a plus.

• Import and export management of drug substance and drug product.

• Understanding of CGMP and CGCP requirements, compendia testing, and ICH and regulatory guidelines including stability data requirements.

• Excellent interpersonal and communication skills (written and oral). This includes the ability to effectively and accurately present data to peers, management, and external partners. Experience with preparation of regulatory documents is desired.

• Excellent ability to work in a goal and team-oriented setting and to handle competing priorities.

• Flexibility within a rapidly changing environment and high attention to details

• Well-developed organizational skills and the ability to thrive under pressure.

• Well-versed in industry trends, emerging business processes and technologies

Technical Knowledge Required:

• Must have excellent PC-based computer skills including Windows, MS Office (Outlook, Word, Excel, PowerPoint, Project), and IRT/RSTM Systems.

• Knowledge of other software: Visio

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. Reasonabl