OnKure is seeking a highly motivated Associate Director or Director of Supply Chain and Operations to join our Pharmaceutical Sciences (PharmSci) team. This role leads supply chain strategy across preclinical and clinical-stage oncology and vascular anomalies programs, drives operational excellence across PharmSci, and supports contracting, timelines, and budgets while guiding CMC operational strategy and ensuring compliance with global regulatory requirements - including supporting external partnerships with CDMOs, CROs, and other service providers and helping hold them to our scientific, quality, and operational standards. The role requires close collaboration with Clinical Operations, Clinical Pharmacology, Quality, Regulatory, and other PharmSci functions to advance our pipeline, along with sound judgment in troubleshooting supply and vendor issues, supporting regulatory submissions, and keeping manufacturing and supply chain activities aligned with GMP and other applicable global regulations.
This is a highly visible, strategic role requiring both operational expertise and strong project management skills. The position is office-based, with on-site responsibilities and occasional travel to support collaborations and audits.
Job Responsibilities:Supply Chain Strategy & Operations (Preclinical and Clinical)
- Develop and execute end-to-end supply chain strategy for drug substance (DS), drug product (DP), and comparator/concomitant medications across preclinical and clinical-stage assets
- Partner with Clinical Operations and Data Management on IRT/RTSM design, configuration, UAT, implementation, and maintenance, aligning enrollment assumptions, randomization requirements, dosing schedules, and clinical supply strategy
- Forecast preclinical and clinical supply needs to drive manufacturing schedules and manage inventory across depots and sites; develop and maintain study-level clinical supply plans incorporating enrollment forecasts, cohort expansion scenarios, dosing requirements, site activation timelines, resupply triggers, and inventory buffers
- Oversee packaging, labeling, distribution, and import/export of IMPs and preclinical materials, including QP release where required; support Clinical Operations with site-level supply readiness and issue resolution (product availability, shipment delays, temperature excursions, accountability questions, and other supply matters affecting study execution)
- Coordinate logistics for preclinical API and toxicology/DMPK supplies to support IND-enabling studies and formulation development
- Manage IMP inventory, resupply, reconciliation, returns, and destruction in compliance with global regulatory requirements; monitor site/depot inventory, enrollment activity, shipment status, and projected demand to proactively coordinate resupply and redistribution, minimizing stock-outs, excess inventory, and impact to patient dosing
- Run scenario planning to stress-test supply forecasts and get ahead of potential shortfalls
- Maintain and update SOPs related to supply chain and operational activities
PharmSci Operations - Contracting, Timelines, and Budgets
- Contracting: Support drafting, review, and negotiation of contracts, master service agreements, SOWs, change orders, and quality agreements with CDMOs, CROs, testing labs, and logistics providers
- Timelines: Help develop and maintain PharmSci program timelines, critical paths, and milestones across formulation, analytical, manufacturing, and supply chain workstreams, partnering with program leads to keep plans aligned
- Budgets: Assist with departmental and program budget management, tracking spend against plan and flagging opportunities to optimize resources
- Support vendor selection, onboarding, and performance monitoring, partnering with functional leads to help ensure deliverables meet scientific, quality, timeline, and budget expectations
- Help maintain operational dashboards and metrics that give the team visibility into program status, risks, and spend
- Partner cross-functionally to help identify and mitigate operational, supply, and vendor risks through contingency planning
Regulatory, Compliance & Collaboration
- Contribute to regulatory CMC strategy and support global regulatory submissions related to packaging, labeling, and distribution
- Track global regulatory changes affecting GMP manufacturing, packaging, labeling, and IMP distribution, and keep internal teams informed and compliant
- Support inspection readiness and audits, ensuring supply chain and manufacturing activities hold up to GMP scrutiny
- Provide leadership in resolving supply chain challenges, optimizing processes, and contributing to project planning and strategic decision-making
Preferred Experience and Qualifications:- Degree (B.S., M.S., M.B.A., or Ph.D.) in life sciences, chemistry, engineering, pharmaceutical sciences, or a related field
- 8-10+ years of relevant pharma/biotech experience
- Expertise developing and executing clinical supply chain strategy, forecasting supply needs, and driving manufacturing and packaging/labeling schedules
- Demonstrated experience managing contracts, timelines, and budgets, and selecting/overseeing CDMOs/CROs for manufacturing, pack, and label; solid working knowledge of GMP and CMC processes
- Demonstrated experience leading projects and collaborating within multidisciplinary teams
- Strong problem-solving abilities, attention to detail, and the capacity to work independently
- Excellent written and verbal communication skills, with the ability to present complex data clearly and concisely
- Familiarity with GMP and GLP regulations and experience with CMC aspects of drug development
- Small molecule late-stage supply chain and operations management
- Experience developing primary and secondary packaging configurations for world markets
- Experience negotiating and managing contracts, budgets, and program timelines in a fast-paced, clinical-stage environment
- Experience with regulatory guidelines outside the US (e.g., EMA, JP, MFDS, etc.)
- Experience managing imports and exports for IMP distribution during clinical trials, as well as import/export strategies during preclinical development
- Proven ability to manage collaborations with concomitant medication partners, CMOs/CDMOs, and CROs
- Experience leading cross-functional teams through challenging supply chain and operational issues in a fast-paced, clinical-stage environment
- Background in FMEA-based or risk-based approaches to identify and manage supply chain and operational risk
To attract the very best talent, OnKure offers a generous compensation and benefits package that includes competitive pay, performance-based bonus opportunities, stock options, insurance coverage (health, dental, life, and disability) for full-time employees, self-managed paid time off, and a 401(k) plan with company match. Candidates who live in or are willing to relocate to the Boulder, CO area are preferred.
The annual compensation range for this role, based on experience, is $170,000-$230,000. Job level and compensation are dependent on relevant education and experience.
