Senior Manager, Clinical Trial Supplies

Crinetics Pharmaceuticals•Headquarters, KY

1d•Onsite

About The Position

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 is responsible for the planning, execution, and oversight of global clinical trial supply operations across multiple clinical programs. This role ensures the timely, compliant, and cost-effective delivery of investigational products (IP), ancillary supplies, and related materials to support clinical studies across all phases. The Senior Manager provides leadership to supply chain teams, partners cross-functionally with Clinical Operations, Manufacturing, Quality, and Regulatory, and acts as a subject matter expert in clinical supply chain strategy and execution.

Requirements

Minimum of a Bachelor’s in life sciences, nursing, business or related field with at least 12 years of related technical experience. Alternatively, a Master’s degree with 8 years of experience (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.
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.
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.

Nice To Haves

Previous experience in rare diseases /oral solid dosage forms is a plus.
Preparation of regulatory documents is desired.

Responsibilities

Develop and lead end-to-end clinical supply strategies for multiple clinical programs and phases (Phase I–IV).
Design optimized supply models, including labeling, packaging, distribution, and inventory strategies.
Assess and mitigate supply risks, including demand uncertainty, enrollment variability, and manufacturing constraints.
Manage clinical trial supply lifecycle activities, including forecasting, demand planning, packaging, labeling, distribution, returns, and destruction.
Ensure uninterrupted supply of investigational and comparator products to global clinical sites.
Manage Interactive Response Technology (IRT) system builds, UAT testing, supply strategies and reconciliation activities.
Partner closely with Clinical Operations, Manufacturing, Quality, Regulatory Affairs, Finance, and external vendors as required to ensure alignment on study timelines and deliverables.
Serve as the clinical supply representative on study teams and governance forums.
Influence study design decisions to optimize supply chain efficiency and patient experience.
Lead selection, contracting, and performance management of external vendors (CMOs, depots, couriers, IRT providers).
Develop and manage clinical supply budgets, vendor quotes, proposals, and timelines.
Drive cost optimization while maintaining quality and compliance.
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.
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.).
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.
Manage activities needed to source comparators and ancillary products. Plan supply strategies, labeling and distribution activities.
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 the CMC team as needed.
Other duties as assigned.