Responsible for the global supply and distribution of drug products and ancillary supplies for Mirum’s ongoing clinical trials through the oversight management of multiple Contract Manufacturing Organizations (CMOs) and distribution providers. The ideal candidate is a self-starter with the ability to work independently under minimal supervision.
- Develop supply strategies that effectively balance complex study designs, tight inventories, and multiple geographic regions.
- Work cross-functionally with Global CTMs and study teams to drive and maintain forecasting projections of Clinical Materials, Drug Product, and Drug substance in support of our global studies.
- Conduct planning and forecasting for the clinical program. Schedule and implement labeling, packaging, and Quality release operations with the CMO and cross-functional Mirum team to ensure continuous clinical supply.
- Define and develop appropriate packaging components and shipping configurations for products. Oversee and coordinate packaging and labeling activities.
- Develop and/or implement and/or oversee drug supply tracking systems.
- Track and manage inventory of GMP products including drug substance, drug product, product retains and ancillary supplies for Mirum’s clinical trial program in compliance with GMPs.
- Author & oversee reports, metrics and presentations to internal stakeholders on study teams and management regarding clinical supply chain status.
- Coordinate shipments between distributors, to depots and sites. Provide follow-ups to shipments and help troubleshoot shipment problems.
- Identifies gaps and risks associated with packaging, labeling, and distribution of the drug product. Partners with internal stakeholders to proactively manage risks.
- Develop processes and systems, draft corresponding SOPs.
- Receive excursion/deviation reports. Oversee investigations in collaboration with Quality, CMOs, and sites.
- B.A./B.S. preferred. 10+ years of experience in Pharmaceutical operations and supplier management functions.
- Must have previous experience with global pharmaceutical clinical supply operations.
- Drug Supply Management skills in multidisciplinary environment with complex strategies and geographical specific requirements and ability to adapt to changes.
- Experience in a small company environment strongly preferred.
Knowledge, Skills and Abilities:
- Proven ability to lead complex contractual negotiations with a deep understanding of financial considerations when it comes to procurement and supply chain.
- Understands and wants to work in a small company environment and is a “doer”.
- Proactive, shows good judgment, anticipates future consequences, and can make decisions decisively in the face of ambiguity.
- Can apply knowledge to new situations.
- Creates a sense of partnership with vendors, but can be direct when needed.
- Thinks outside the box, and come up with creative solutions when faced with challenges.
- Not afraid to speak up when there is a better way to do something.
- Has integrity, honesty, conscientiousness, is team-oriented and willing to jump in wherever needed, and organized.
- Working knowledge of relevant GxP requirements.
To apply, please send your resume to email@example.com.