Associate Director Clinical Supply Management
About Corvus Pharmaceuticals
Corvus Pharmaceuticals is a clinical-stage biopharmaceutical company dedicated to developing novel therapies with the potential to significantly improve the treatment of immune diseases and cancer. Our lead program, soquelitinib, is a first-in-class oral therapy that selectively inhibits ITK to modulate and control parallel signaling pathways in the immune system. Soquelitinib is being studied in a Phase 3 oncology study as well as studies for autoimmune disorders. We are a science-focused team committed to developing precisely targeted medicines with differentiated mechanisms of action to improve the lives of patients.
Role Summary
The Associate Director of Clinical Supply Management will lead clinical supply activities for Corvus programs and be responsible for the end-to-end clinical supply chain for Corvus clinical trials. The position includes all elements of the clinical supply chain from the protocol design through manufacturing to distribution and inventory management of clinical supplies at clinical sites.
Specific Job Responsibilities
- Serve as the clinical supply lead for Corvus' programs and develop and manage the clinical supply plan.
- Plan and deliver on-time, compliant clinical supply according to the clinical development plan.
- Collaborate with cross-functional teams (Clinical Operations, QA, Manufacturing, and Regulatory) to ensure uninterrupted supply for clinical programs.
- Lead and manage clinical supply and logistics activities, including but not limited to demand forecasting and supply planning, IRT start-up and maintenance, label generation and approval, packaging and labeling operations, release and distribution, expiry extension, cold chain management, and inventory management.
- Author, review, and/or approve related clinical and technical documents, including but not limited to clinical label text, clinical/master batch record, clinical trial protocol, pharmacy manual, IND, IMPD, and NDA.
- Conduct necessary training and develop/improve required SOPs.
Knowledge and skills
- Excellent verbal, written and interpersonal communication skills are required.
- Strong computer, database and organizational skills are required.
- Be able to manage the resources and timelines for programs of high complexity.
- Possesses experience with clinical blinding practices in a global study, from Phase 1 to Late Phase.
- Mature knowledge of the FDA, CGMP, GCP standards and regulatory guidance documents.
- Possess strong clinical supplies management experience/knowledge in forecasting, demand/supply planning, IRT systems, inventory management, clinical labeling, distribution including cold chain, import/export.
- Possesses strong collaboration, influencing and negotiation skills to work effectively with internal cross-functional groups and external suppliers to meet the aggressive clinical study timeline and patient needs.
- Leads through ambiguity; can assess options quickly and efficiently implement the best option in alignment with Corvus’s culture and expectations for clinical timelines.
Skills And Experience
- MS or BS in chemistry, pharmaceutics or a related discipline; advanced degree preferred.
- 8+ years of experience in supply chain in the pharmaceutical/biotechnology industry.
Salary Range: $150,000 – $200,000
If you are interested, please submit a cover letter and your resume to careers@corvuspharma.com
