Manager, Clinical Supply Chain

About 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 Role:

The Manager, Clinical Supply Chain position supports end-to-end clinical drug supply on multiple Edgewise clinical programs under the oversight of Clinical Supply Chain leadership. 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, Quality, CMC, Regulatory Affairs, Medical Affairs, and external vendors.

Essential Job Duties & Functions:

• Manage labeling, transportation, storage, and distribution of clinical trial material for global clinical studies.
• Develop and maintain clinical supply forecasts to ensure accurate demand and inventory levels for finished product and help inform drug product demand planning. Utilize planning tools to evaluate supply scenarios and support manufacturing planning.
• Facilitate and manage vendors for labeling and distribution of clinical study operations, individual study contracts, label translations, and supporting services.
• Identify and manage vendors for sourcing of ancillary supplies and comparator materials.
• Collaborate with Clinical Operations teams to align on 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 with setup, maintenance, and oversight of interactive response technology (IRT) systems used for investigational product management.
• Work closely 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.
• Participate in cross-functional or departmental initiatives focused on continuous improvement of clinical supply chain processes.
• Provide subject matter expertise and contribute to the development and review of SOP's, protocols, IRT specifications, vendor documents, and pharmacy manuals.
• 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:

• BA or BS in science or relevant field
• 4-8 years of experience in clinical pharmaceutical product supply chain management or related field, or 2-5 years with an advanced degree (Pharm.D., etc.).
• Thorough understanding of regulatory requirements for clinical supply labeling and distribution in the US and EU.
• Thorough understanding of cGMP, GCP, GDP.
• Knowledge and understanding of Supply Chain principles.
• Strong organizational, analytical and interpersonal skills.
• Strong Microsoft Office Skills
• Ability to work in a fast paced, dynamic environment with multiple projects.
• Strong relationship management skills and enthusiasm for continuous development

Salary range: $130,000 - $160,000, title and salary commensurate with experience.

Our 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.