Associate Director/Director, Clinical Supply Chain Operations (EDG-2025054) - Edgewise Therapeutics : Job Details

Associate Director/Director, Clinical Supply Chain OperationsAbout Edgewise Therapeutics:At Edgewise, we are on a mission to discover new medicines that improve the lives of patients facing serious muscle disease. Our intimate knowledge of muscle biology and biophysics along with our ability to identify and design muscle specific precision small molecules have enabled us to rapidly advance our skeletal muscle and cardiac muscle product candidates into the clinic while also building a robust pre-clinical pipeline. With this focus on therapeutics designed to protect and improve muscle health, our goal is to dramatically enhance the lives of people living with progressive muscle disorders. We have assembled an experienced and highly motivated leadership team with a strong track record in the biotechnology and pharmaceutical industry to build the leading, global muscle disease biopharmaceutical company. Come join us make a significant difference in the lives of patients!About the Position:The Associate Director/Director of Clinical Supply Chain position ensures strategic end-to-end clinical drug supply for all Edgewise clinical programs. Broad responsibilities include supply chain development, global forecasting and inventory management, labeling and packaging oversight, bulk product and finished product distribution, and risk mitigation implementation. Collaborate with Clinical Operations, Medical Affairs, Quality, CMC, and external vendors.Essential Job Duties and Functions:

• Manage end-to-end supply chain management with focus on clinical programs. Includes labeling, transportation, storage, and distribution of clinical trial material for global clinical studies.
• Lead supply planning forecasting activities to ensure accurate demand signals and inventory levels are incorporated into the overall supply plan for manufacture of API and bulk IP. Utilize planning tools to ensure appropriate clinical supply scenarios are considered. Manage supply chain risk mitigation analysis, response and implementation.
• Coordinate labeling, transportation, storage and distribution of drug product for compassionate use programs in North America, Europe, Australia, and Asia.
• Negotiate, facilitate and manage vendors for all labeling and distribution of clinical study operations, individual study contracts, label translations, and supporting services.
• Identify and manage vendors for sourcing of comparator materials including price negotiations.
• Collaborate with Clinical Operations teams to align the global supply strategy for clinical study IP with the study protocols.
• Work with the Global Medical Affairs teams to define the global supply strategy for IP to support Investigator Initiated Trials (IITs) and collaborative studies, in alignment with the study protocols.
• Support Clinical Operations in contract negotiation, and development and ongoing maintenance of interactive response technology and systems used for the management of IP in clinical studies.
• Partner with Quality Assurance, Regulatory Affairs, Clinical Operations, Global Medical Affairs and Manufacturing/CMC to ensure uninterrupted and compliant supply of IP for assigned clinical studies.
• Lead implementation teams focused on continuous improvement of the Clinical Supply Chain processes.
• Provide subject matter expertise and participate in the development and review of SOP's, protocols, IRT specifications, vendor documents and pharmacy manuals.
• Provide direct line management of Clinical Supply Associate(s).
• Provide mentorship and/ or training to junior team members
• Read, understand, and comply with all workplace health and safety policies; safe work practices; and company policies and procedures.
• Perform other duties as assigned by supervisor.

Required Education, Experience and Skills:Skills:

• Thorough understanding of regulatory requirements for clinical supply distribution in US and EU including testing and labeling. Knowledge of Latin American requirements helpful. Knowledge of compassionate use requirements desirable.
• Thorough understanding of cGMP, GCP, GDP and national/international transportation requirements for pharmaceutical materials
• Knowledge and understanding of Supply Chain principles; Supply Chain Management qualification desirable but not essential.
• Strong organizational, analytical and interpersonal skills.
• Ability to work in a fast paced, dynamic environment with multiple projects.
• Strong Influencing and relationship management skills

Education and Experience:

• BA or BS in science or relevant field
• Minimum of 14 years of experience in pharmaceutical product supply chain management or related field with at least 5 years of this in a clinical setting.

Salary range: $160,000 - $210,000, title and salary commensurate with experienceOur Benefits: We are proud to offer health benefits, a discretionary bonus plan, stock option grants. a stock purchase plan, a 401(k) with match and paid time off to our team members as part of their compensation plan. There is no deadline because the employer accepts applications on an ongoing basis. Edgewise does not accept resumes from recruitment agencies for this position. Please do not send resumes to Edgewise employees or the company location. Edgewise is not responsible for any fees related to unsolicited resumes.