Director of Supply Chain

Director of Supply Chain

Dragonfly Therapeutics is seeking a full-time Director of Supply Chain who brings enthusiasm, thoroughness, and a desire to drive novel immunotherapy programs.  The candidate must be independent, goal-oriented, flexible, and able to work efficiently across competing priorities. We are searching for innovative individuals who thrive in a fast-paced environment and are dedicated to improving the lives of our patients. 

This position will work closely with key stake holders including Clinical Operations, Clinical Development, Quality Assurance, Regulatory Affairs, Contract Manufacturing Operations (CMO’s), and Contract Research Operations (CRO’s) to ensure seamless supply of Clinical Trial Material. The incumbent will also expected to set up a robust clinical supply model to support ongoing and upcoming clinical trials that aligns with corporate goals. This position will help to establish a robust S&OP process, deliver long range supply plans, support packaging and labeling activities and vendor oversight, and develop fit-for-purpose inventory management practices. A successful candidate will be skilled at understanding the Clinical Supply needs and responsibilities, exhibit strong attention to detail, and support a collaborative environment.

Responsibilities (including but not limited to):

• Partner with Clinical Operations to identify demand assumptions and review enrollment plans and actuals for use in developing drug product and finished goods supply plans.
• Review clinical trial protocols to understand supply chain drivers and create trial specific strategies.
• Create, review, and update the clinical supply plan for each study; apply simulation tools to drive optimal clinical supply plan as appropriate.
• Ensure changes in supply configuration, trial design, enrollment timeline, manufacturing availability and regulatory requirements are considered.
• Establish US and international distribution and logistics strategies for all clinical programs.
• Monitor enrollment activity and inventory levels at depots and clinical sites through the life of a trial; take preventative actions to avoid potential supply issues
• Oversee end-to-end label development process
• Lead establishment of IRT User Requirement Specifications and participate in User Acceptance Testing
• Develop packaging and supply strategies to maximize supply efficiency, minimize waste while identifying risk and develop risk mitigation plans
• Communicate with external manufacturing and technology partners on project requirements, priorities, performance metrics and areas for improvement
• Monitor, establish, and manage the creation of SOPs and work instructions that impact the department's day to day operations
• Achieve operational objectives by contributing information and recommendations to strategic plans and budget reviews
• Prepare and manage budget across assigned protocols and/or programs utilizing budget, planning, and allocation tools
• Collaborate with cross-functional internal and external teams on regulatory submissions, queries from Health Authorities
• Liaise with external alliance and collaboration partners on supply chain related matters to support successful outcomes for all parties

Qualifications:

• Bachelors degree in Biological Sciences, or related field
• >10 years’ experience working within a GXP environment, specifically focused on oncology and immunology treatments
• >5 years experience leading a cross functional supply chain team while managing employee development and performance
• Proven experience in clinical supplies environment with a strong understanding of clinical study design, execution, and impact of study drug supply from study start-up through trial completion
• Knowledge of global regulatory submission processes and timelines impacting supply chain related activities
• Experience designing, testing, implementing and maintaining IRT and inventory management systems
• Demonstrated experience in leading demand forecasting, supply planning and inventory management processes to meet global drug supply requirements
• Sourcing and procurement experience with combination and comparator therapies, and medical devices
• Excellent organizational and multitasking skills as required to work in an extremely fast-paced environment with changing priorities
• Excellent communication and influencing skills, strong collaboration skills and attention to detail
• Demonstrated ability to prioritize and manage activities independently in a complex external environment