Clinical Supply Lead

Job Title: Clinical Supply Lead

Job Number: 28557

Location: Cambridge, MA

Job Description

Reporting to the Clinical Supply Leader, the Clinical Supply Lead (CSL) will be responsible for end-to-end supply chain activities of clinical programs. The CSL will represent the supply chain function on program teams as well as clinical study teams. Responsibilities include forecasting demand for Investigational Product and non-investigational supplies for a program, managing Finished Goods manufacturing activities as well as the distribution process, in compliance with Health Authority regulations and internal SOPs. The CSL builds and maintains critical collaborations with Clinical Operations, Clinical Development, Manufacturing, Discovery, Quality Assurance, Regulatory Affairs, and Operations.  This role has high visibility and far-reaching impact across multiple departments and external vendors.  In addition, there is significant diversity in the types of clinical candidates and the global locations of our clinical studies that contribute positively to the scope of this important role

Responsibilities

• Has accountability for Investigational and Non-Investigational Product supply planning and execution, inventory control, and distribution activities including label/pack execution, vendoroversight, and change management to support clinicalstudy objectives and timelines.
• Partners with Clinical Operations and Project Management to identify demand assumptions and create, review, and update the clinical supply and demand plans
• In collaboration with the Clinical Supply Leader, reviews clinical study protocols and understands impact to supply; ensure changes in study design, enrollment, and regulatory requirements are considered in the supply plans.
• Oversees vendor activities including procurement, labeling performance, on-time delivery, quality, and issue resolution.
• Monitors inventory levels at depots and clinical sites; is proactive with preventative actions to avoid potential supply issues

Required Skills

• Bachelor’s degree required; MBA a plus
• 10+ years of relevant experience in clinical drug supply in the vaccines, pharma, or biotech industry. Experience in supplying international clinical studies strongly preferred.
• A collaborative problem solver
• Proven track record in managing a clinical supply chain in an outsourced model; management of CMOs is of particular importance.
• Proven track record of strong collaboration with internal and external stakeholders.
• Experience in CMO and CRO management, including labeling, packaging, and global distribution
• Knowledge of cGMPs and regulatory guidance
• Strong analytical and organizational skills