Senior Director, 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 Director, Clinical Trial Supplies, is an end-to end clinical supply planning leader that provides relevant expertise in a fast paced biotech environment. This individual will perform strategic, clinical supply management for its clinical development programs (phase 1, 2, 3) and support commercial launch, and will report to the SVP, Technical Operations.

The Senior Director works internally with other members of Global Supply Chain (GSC) and other Crinetics functions – e.g., Clinical Development, Clinical Operations, Product Development & Manufacturing (PDM), Quality Assurance, Regulatory, and Project Management Office - to develop and formulate supply chain strategies, meet project deliverables, solve business problems and create a competitive advantage.  This position includes all elements of the clinical supply planning from the protocol design through manufacturing to the ultimate distribution and inventory management of clinical supplies at clinical sites worldwide. The individual has an expert working knowledge of clinical supply chain best practices and experience working with a GxP environment.

The individual will also have strong, cross-functional, multi-cultural awareness and communication skills to lead in a fast-paced, global company. The Technical Operations 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:

• Serve as the clinical supply lead on CMC sub-teams and Clinical Operations teams  especially for complex development programs - e.g., late phase, acquisition, partnership/alliance, new modality, etc.).

• Lead the development and execution of overall clinical supply strategy and management for clinical development program(s), including management of investigational medicinal product (IMP) for assigned global trials and domestic trials.

• Oversee and support clinical study planners in a matrix environment. Facilitate issue and risk identification, mitigation, resolution and communication.

• Drive decision-making at cross-functional teams (ClinOps, PDM sub-teams) supporting the long-term vision.

• Identify, manage and mitigate supply risks at clinical development program level. Lead and drive visible, impactful process improvements and change business and organizational imperatives.

• Author, revise, and review standard operating procedures (SOPs), work instructions, and business policies.

• Manage clinical supply budget of assigned clinical development program(s).

• Review and approve statements of work, purchase orders, and invoices.

• Influence (and at times drive) program allocations at partners, including contract manufacturing organizations (CMOs).

• Oversee 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.

• Ensure timely execution of domestic and international distribution of Clinical Trial Materials for all therapeutic programs. Plan appropriate inventory at warehouse and site levels and monitor drug supply usage, use date expiry, drug returns, field transfers, and destruction.

• Forecast demands for clinical supplies and coordinate production and shelf-life extension with the Drug Product and Analytical team.

• Select, implement, and manage IRT systems from set up to close out with Data Management and Clinical Operations.

• Create and manage a global team of skilled professionals, mentoring them in all matters related to clinical supplies.

• Develop strategic projec