Job Description

This position offers the opportunity to lead the Clinical Supply function for a clinical development pipeline of innovative treatments that address areas of high unmet medical needs. We have a thriving, flexible work culture supported by sustainable financial growth. We have treated over one million patients with our first commercial product.

We are seeking is a Clinical Supplies Manager who will provide oversight and manage the who is customer-oriented, and highly collaborative to lead the packaging, labeling and distribution of investigational product and be a key contributor in the commercialization of assets. This individual will serve as a key connection point between Clinical Operations, Pharmaceutical Development and Technical Operations. The ideal candidate will be able to engage and establish effective working relationships with internal stakeholders across multiple departments including Finance, Regulatory Affairs, and Quality Assurance. Responsibilities: • Design and execute packaging and labeling campaigns: • Translate clinical protocol information into demand forecasts and supply strategies • Develop campaign timelines and budgets • Develop IRT supply specifications and clinical label texts • Manage CMOs to deliver study material on time\ budget • Manage IP distribution through study closeout and drug destruction • Lead process improvement initiatives and author\ revise clinical supply SOPs • Enable successful clinical trials using supply chain management processes (Plan, Source, Make, Deliver, and Return) • Manage relationships with packaging and labeling CMOs and track vendor performance. Managing Contracts, Expenses, Invoices, Annual Budgets • Serve as a primary interviewee in regulatory inspections\ audits as needed Qualifications: • Bachelor degree in scientific discipline with 5+ years of relevant clinical supply chain experience • Excellent communication, interpersonal, and follow-through skills with strong attention to detail • Solid understanding of cGMPs and the clinical research process • Expertise investigation of complaints, product rejections, non-conformances, recalls, deviations, audits, regulatory inspections and findings, and trends from process performance and product quality monitoring and experience implementation of Corrective Actions and Preventive Actions (CAPA) resulting from these investigations • Experience managing contract packaging for commercial products and clinical supplies and labeling organizations (strongly preferred) • Experience with IRT systems and ex-US clinical supplies management (considered a plus)

Company Description

Beacon Hill Pharma, Beacon Hill Staffing Group's Pharma specialty division, is a national staffing organization that provides contract, direct (permanent), FSP/outsourcing and consulting to pharmaceutical, medical device, biotech and contract research organizations. Beacon Hill Pharma places contractors in all 50 states by seamlessly coordinating recruiting resources in local and regional markets with Beacon Hill Pharmas National Recruiting & Delivery, a dedicated national recruiting team that focuses exclusively on national accounts, supporting regional recruiting operations and delivering contractors to all markets in the U.S. Whether start-ups or the Fortune 500, the public or private sector, Beacon Hill Pharma matches world class talent with exceptional opportunities.