Job Title: Assoc. Director/Director, Clinical Supply Chain
Job Number: 24177
Location: 215 First Street 4th Floor Cambridge, MA 02142
As clinical demands grow more complex, the need for comprehensive and dynamic clinical supply chain services continues to intensify. The Associate Director/Director, Clinical Drug Supply, will provide broad-based leadership supporting initiation and continuity of Investigational Medicinal Product (IMP) for clinical trials and be responsible for supply chain activity across a portfolio of protocols. He/she will provide Clinical Drug supply inventories and forecast/demand reports including full accountability for end to end clinical supplies encompassing drug substance, drug product and finished goods for our portfolio of products. The role requires a deep understanding of clinical supply chain networks, clinical regulations, timelines and analytics to facilitate communications across a variety of functions, and to develop cost effective clinical supply solutions.
Leading and working with cross functional teams, this role will align demand with supply plans, drive manufacturing execution, and manage distribution of the resulting inventory while minimizing supply chain risks to avoid any potential for supply disruption. The Associate Director/Director will build and maintain key collaborative relationships with Clinical Operations, Pharmaceutical Development and all Operational functions. This position requires a high level of organizational skills to effectively balance a diverse workload.
The primary responsibility of the Associate Director/Director, Clinical Drug Supplies will be the ability to develop supply plans to deliver clinical trial material requirements, develop risk mitigated supply scenarios, and formulate plans to ensure continuous supply.
- Direct control of all clinical supply with associated compliance activities for all of Goldfinch’s Clinical Assets. Responsible for managing all aspects of clinical supply planning, manufacturing oversight, and distribution compliant with regulatory requirements and ensuring business continuity.
- Track and routinely report on progress to manufacturing and distribution plans, monitoring metrics to better understand supply chain performance.
- Establish and manage global distribution networks to support clinical trial activity. Develop and maintain strategic alliances with contract partners for transportation, brokerage, storage and distribution.
- Identify strategic supply risks and implement corrective actions to maintain supply continuity.
- Gather and analyze information related to demand, inventory, production, and/or distribution plans, for programs or product types, from various systems like Oracle, IVRS/IRT, planning systems and databases. Continually seek to drive improvements across these systems.
- In collaboration with VP, Pharmaceutical Development, manage annual clinical supplies budgets, monitoring expense and inventory budget, reconciling variances.
- Excellent quantitative/problem solving skills are a core requirement for this role including experience developing complex spreadsheets. Adept ability to convert detailed data into broad scenarios while clearly identifying assumptions and decision points using tools such as PowerPoint, Project, Excel, etc.
- Ability to develop new business relationships and nurture partnerships with internal and external stakeholders. Ability to provide strong cross-functional team leadership, in order to maintain alignment and to set/meet collaborative operational goals. Excellent written and verbal communicator to facilitate/articulate recommendations and key decision points to senior management. Demonstrated experience reducing complex subjects to key points and ability to develop strong networks.
- Solid knowledge of clinical development processes and decision points required and packaging/label development.; experience working on early and late stage development programs a plus.
- If appropriate, lead CMC project team or take role as CMC project manager for a small molecule and/or biologic asset.
- Education: B.S. / B.A required in a clinical or scientific field; MBA preferred. Deep knowledge of global supply chain practices (APICS certification desired)
- At least 7-10 years of strong business experience in overall planning, demand forecasting/supply planning, supply chain management and/or distribution required within the pharmaceutical and/or biotechnology industry, with at least 5 years of experience as a clinical supplies manager or equivalent.
- Experience working in rare disease indications preferred
- Extensive experience in managing US and International (as needed) CRO/CMOs.
- Substantial experience with projects in late pre-clinical and clinical development (Phase 1 – Phase 3) including multiple pharmaceutical dosage forms (parenteral products and solid oral dosages)
- Experience working within a cGMP supply chain environment is essential. Experience with GDP, GMP and GCP regulations a plus. Experience in planning in an MRP-based production environment is a plus.
- Experience with clinical forecasting systems desired.
- Experience as a CMC project team leader and manager preferred. Knowledge across all Pharmaceutical Development related activities including process chemistry and/or cell line development, formulation, analytical development, manufacturing and supply of clinical trial materials and product registration is a plus.
- Outstanding organizational skills and ability to prioritize
- Ability to thrive in a rapidly paced environment within fixed, hard deadlines
- Willing to travel as required