Associate Director, Clinical Trials Supplies

Role Summary

The Associate Director, Clinical Trials Supplies performs strategic clinical supply management for development programs (Phase 1–3) and reports to the Director, Clinical Trial Supplies. The CMC team collaborates with a global network of CROs and CDMOs to support clinical materials development and delivery.

Responsibilities

• 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.

Qualifications

• 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

Skills

• 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

Additional Requirements

• Travel: You may be required to travel for up to 20% of your time.
• Physical Demands: Physical demands include sitting at a desk for extended periods, occasional walking, and lifting up to 25 lbs; laboratory activities in biology/chemical environments may be required; the work environment is typically low to moderate noise.