Associate Director, Clinical Trial Material Supply Management

Zenas BioPharma is a global biopharmaceutical company committed to becoming a leader in the development and commercialization of immune-based therapies for patients around the world. With clinical development and operations globally, Zenas is advancing a deep and balanced global portfolio of potential first- and best-in-class autoimmune therapeutics in areas of high unmet medical need while meeting the value requirements of the dynamic global healthcare environment. The company’s pipeline continues to grow through our successful business development strategy. Our experienced leadership team and network of business partners drive operational excellence to deliver potentially transformative therapies to improve the lives of those living with autoimmune and rare diseases. 

We are seeking top talent who share our commitment to patients and have a track record of success in acquiring, developing and commercializing products across the globe. Our colleagues have an opportunity to engage in a fast-paced learning environment and experience individual and organizational success as we work towards becoming a global immunology and autoimmune disease leader, while living our values of Transparency, Relationships, Urgency, Excellence and Innovation – TRUE Innovation!

Position Summary:   

The Associate Director of Clinical Trial Material Supply Management will provide global program direction and subject matter expertise in clinical trial material supply management.  S/he will work with internal and external teams to develop biologics clinical trial material supply chain strategy and ensure effectiveness of execution.  In accordance with Zenas’ outsourcing model for drug development, the incumbent will oversee the planning and execution of outsourced clinical trial material supply chain activities and will work proactively with external partners to define project scope, mitigate risks, and ensure successful delivery with regard to technical quality, timelines and budget.  S/he will work within a cross-functional development team environment to support Zenas’ short-, intermediate- and long-term strategic goals. 

Key Responsibilities:

• Interact effectively and transparently with internal stakeholders in the areas of Clinical Operations, Clinical Development, Program Management, Drug Product Development and Manufacturing, Analytical Development and Quality Control, Quality Assurance, Regulatory Affairs, Strategic Sourcing and Vendor Management, and external business partners.
• Develop and maintain clinical trial material study/program forecasts and supply plans, collaborating with clinical operations and technical operations
• Integrate the clinical trial material supply plan with manufacturing operations to create a supply chain logistics and distribution plan and manage the clinical trial material inventory to support clinical trial initiation and on-going clinical trials.
• Oversee operations related to labeling and packaging of vials and prefilled syringes clinical trial materials. In partnership with QA, support deviation investigation and associated CAPAs for clinical trial materials release for clinical use.
• Manage distribution, return, and destruction activities, track clinical trial materials, inventories and expiry dates, and coordinate import/export requirements related to the clinical trial materials.
• Lead and coordinate over-labeling date extension activities.
• Develop direct-to-patient plans for assigned programs/clinical studies
• Lead development of global label text and translations for clinical studies working with the internal Zenas functional groups, CRO and CTM vendors.
• Contribute to the development and design of clinical trial IRTs by providing the clinical supplies and depot user requirement specifications and performing the user acceptance testing.
• Budget/scope management related to clinical trial material supply chain.
• Pro-actively collaborate with internal stakeholders and external business partners to achieve group, departmental and corporate goals. Support business partner obligations.
• Provide clear communication to the management team regarding progress against technical objectives/milestones.
• Ensure well-organized, clear, and complete records of all activities across areas of responsibility.
• Develop and maintain SOPs, policies, and guidance documents relevant to areas of responsibility.
• Manage and execute personnel qualification/training program.

Qualifications:

• BS/BA in science or engineering or a related field with a minimum of 7 years hands-on working experience in clinical trial material supply management in the biopharmaceutical industry is required. Advanced degree preferred.
• Must have hands-on working experience