Senior Manager, Clinical Trial Supplies

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:

The Senior Manager, Clinical Trial Supplies, will be responsible for providing support to the Chemistry, Manufacturing and Control (CMC) Team to ensure clinical supplies are packaged, labeled, and distributed on time to support Phase 1-3 clinical trials. This includes but is not limited to managing the drug supply to assure availability of drug product and supporting the relationships with third-party service providers. They will be an integral part of the company’s effort to discover, develop, and commercialize small molecule therapeutics for rare endocrine disorders and endocrine-related tumors. This is a unique opportunity to work with a proven and well-funded drug discovery and development team in a small company environment in the heart of San Diego’s biotechnology community. 

Essential Job Functions and Responsibilities:

These may include but are not limited to:

• Organize or assist with all activities involved with the management of clinical supplies.

• Coordinate and manage the forecasting, procurement, packaging, labeling, distribution, return, reconciliation, and destruction activities of investigational products and ancillary items (i.e., labeling components).

• Work with both internal and external customers and suppliers to develop and communicate clinical supply strategy (including project budgets and timelines) and to ensure that all project objectives are met in a timely and in a compliant manner.

• Collaborate with clinical teams to forecast global demand and identify appropriate inventory levels; distribute monthly inventory and distribution reports.

• Facilitate the development, negotiation, and approval of formal quotes/work orders/proposals.

• Confirm production plans and shipping schedules; develop depot/site resupply strategies and coordinate packaging schedules with third-party provider(s) to support clinical demand changes, i.e., change in distribution timelines for new studies, enrollment changes, additional sites, etc.

• Track the import and customs clearance of bulk and labeled clinical supplies to depots.

• Work with third-party providers to develop detailed project plans and timelines for the packaging, release, and distribution of clinical supplies.

• Coordinate the review and approval of provider documentation (distribution instructions, label proofs, packaging specifications and methods, packaging batch records, etc.).

• Contribute to CMC content of drug manuals.

• Plan and oversee the implementation of expiry date extensions.

• Coordinate the assessment of and track temperature excursions during storage, receipt, or transit to clinical sites or depots.

• Support the transportation and disposition of returned/unused materials, as needed.

• Provide support to source comparators and placebos.

• Support the development of Standard Operating Procedures (SOPs) and guidelines related to third-party provider management, inventory management, distribution, transportation, disposition of returned/unused materials, etc.

• Support CMC team as needed.

• Other duties as assigned.

Education and Experience:

Required:

• A bachelor or master’s degree in in life sciences, engineering, nursing, business, or relevant discipline with at least 7 years of related technical experience with increasing responsibility in biopharmaceutical development (an equivalent combination of experience and education may be considered).

• Previous experience in Project Management, Pharmaceutical Development, Clinical Supply Management, and/or Clinical Trials Coordination.

• 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 re