Job Description
Job Summary: We are seeking an experienced Sr Manager of Clinical Supplies Management professional to oversee clinical supplies end-to-end activities for multiple clinical trials. We are a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders. Our core Values of Trust, Ownership, Curiosity, and Results are foundational to every aspect of our business. Main Responsibilities: • Manage clinical supplies end-to-end activities for multiple clinical trials, including forecasting and planning, trial supply management, packaging, labeling, inventory levels monitoring, and distribution activities. • Oversee packaging, labeling, and distribution activities conducted at contract service providers, including request and review of proposals, communication of project requirements, and management of project execution. • Interpret clinical study protocols to determine drug supply forecast and inventory requirements. • Collaborate with relevant partners to create packaging design based on clinical study needs to ensure optimized supply plan. • Manage the development of study-specific labels that comply with SOPs and applicable regulations. • Responsible for the labeling, distribution, returns, reconciliation, and destruction of supplies to support global clinical studies at all clinical phases of development. • Manage batch record review and release of packaging/labeling activities of clinical supplies. • Manage inventory levels at depots and sites to ensure supply continuity, identify risks, and minimize waste. • Develop and maintain Pharmacy Manuals in collaboration with clinical operations and clinical development. • Responsibilities include budgeting, forecasting, strategic planning, tracking the performance of contract service providers, and review/approval of invoices. • Manage internal and third-party deviations, customer complaints, and change controls. • Ensure all study-related GMP documents are accurate and filed in a timely fashion in the TMF as per Good Manufacturing Practices and Good Clinical Practices guidelines. • Participate in the selection, design, configuration, review, and User Acceptance Testing of IRT systems for drug supply management, accountability, and randomization of global clinical studies. • Partner with the Quality function to maintain inspection readiness for activities pertaining to labeling and distribution practices. • Manage and resolve supply chain-related issues such as shipment-related incidents and other time-sensitive issues. Qualifications and Key Success Factors: • Bachelor's Degree in Supply Chain, Pharmacy, Pharmaceutical Sciences, Engineering, or related field required. • 5+ years of pharmaceutical industry experience with a minimum of 3-5 years of experience in clinical supplies management. • Significant experience in managing global phase I to phase IV clinical studies. • Proven track record of effective collaboration and communication skills with internal partners and external providers. • Detailed understanding of Good Manufacturing Practices and Good Distribution Practices requirements, QP requirements, EU GDPs, Annex 13, CFR regulations, and ICH guidelines governing conduct of clinical studies. • Project management skills and expertise in outsourcing and vendor management. • Experience and understanding of supply chain, including importation process and customs clearance. Benefits: • Competitive base salary in the range of $137,000 - $146,000. • 401k plan with 100% match up to 6% of employee contribution (Traditional & Roth). • Wellness benefits of $200/month to cover flexible options. • Unlimited PTO and 2 weeklong shutdowns each year. • Generous extended family leave benefit. • Eligibility for equity awards and Employee Stock Purchase Plan (15% discount).