Biogen Associate Director, Clinical Supply Chain Planning in Cambridge, Massachusetts
Our supply team was recently listed in Gartner’s 2020 Supply Chain Top 25!
The Associate Director, Clinical Planning will be responsible for supply chain activity across a portfolio of protocols. Leading and working with cross-functional teams, this role will have oversight of Clinical Asset Planners and Clinical Supply Managers who 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 role will set a vision with the Therapeutic Area, support the program asset teams, and drive continuous improvements throughout Clinical Drug Supply. The Associate Director will build and maintain key collaborative relationships with Clinical Operations, Global Supply Chain and all Operational functions. This position requires a high level of organizational skills to effectively balance a diverse workload.
Specific responsibilities include:
The ability to review or develop supply plans to deliver clinical trial material requirements, develop risk mitigated supply scenarios, and formulate plans to ensure continuous supply while minimizing E&O.
Direct and control all clinical supply and compliance activities across a Therapeutic Area of Biogen’s Clinical Assets, operating across Biologics, Pharmaceuticals, Antisense Oligonucleotides, and Gene Therapy. Including but not limited to PO&T, Finance, Commercial Launch, Medical Affairs, Clinical, and R&D. Responsible for managing all aspects of clinical 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. Work globally to leverage and develop consistent, repeatable best distribution practices for group.
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, planning systems and databases. Continually seek to drive improvements across these systems.
Provide study management guidance and mentoring to other employees within group.
Build strong, enduring relationships with stakeholder groups, and act as key escalation point for internal customers and cross-functional partners.
Develop analytical presentations in support of supply chain recommendations to achieve clinical and patient requirements.
Manage implementation and user administration for Clinical Drug Supply (CDS) system. Identifies tools, systems and software to enhance end to end visibility, reduce manual errors and improve content available to Asset Planners and Clinical Supply Managers in day to day operations. Including managing existing systems and evaluating new systems for implementation.
Manage annual budgets, monitoring expense and inventory budget, reconciling variances.
Strong people management skills including coaching, mentoring and development.
Provide guidance and leadership with regard to Master Data Management and Quality systems.
Apply solid understanding of clinical regulatory environment, as well as packaging and label development.
Managing a team of 2-8 people.
Minimum 12 years of strong business experience, or equivalent combination of education and experience in overall planning, demand forecasting/supply planning, supply chain management and/or distribution required. Experience working within a cGMP supply chain environment is desired. Experience with GDP, GMP and GCP regulations a plus. Experience in planning in an MRP-based production environment is a plus and clinical forecasting systems desired.
B.S. / B.A required, MBA preferred (APICS certification desired)
Excellent quantitative/problem-solving skills are a core requirement of this job, including experience developing complex Excel spreadsheets. Adept ability to convert detailed data into broad scenarios while clearly identifying assumptions and decision points using Microsoft tools like PowerPoint, Project, Visio etc.
Ability to develop new business relationships, and to nurture partnerships with internal and external stakeholders. Ability to provide strong cross-functional team leadership, in order to maintain alignment and to set and meet collaborative operational goals.
Excellent written and verbal communicator with ability to facilitate/articulate recommendations and key decision points to senior management; demonstrated experience reducing complex subjects to key points; ability to develop strong network across company. Ability to develop improvement strategies related to supply chain processes and systems.
Solid knowledge of clinical development processes and decision points required; experience working on early and late-stage development programs a plus. High level of comfort with financial analysis in a portfolio management setting and comfortable evaluating and communicating alternatives based on underlying economic/accounting drivers.
As clinical demand signals grow more complex, the need for comprehensive and dynamic clinical supply chain services continues to intensify. The Associate Director, Clinical Drug Supply, will provide broad-based leadership supporting initiation and continuity of Investigational Medicinal Product (IMP) for clinical trials. Clinical Drug supply reports in the Global Supply Chain organization, and is full accountable for end to end clinical supplies. The role will lead a team of Clinical Asset Planners and Clinical Supply Managers to ensure clinical supplies with in a Therapeutic Area. Supply plans encompass drug substance, drug product and finished goods for a portfolio of products. The role requires a deep understanding of supply chain networks, clinical regulations, timelines and analytics to facilitate communications across a variety of functions, and to develop cost effective clinical supply solutions balancing multiple business objectives.