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Associate Director, Clinical Supply Capabilities (IRT)

Company: Biogen
Location: Cambridge
Posted on: January 26, 2023

Job Description:

Company Description

Job Description

About This Role

As clinical demand signals grow more complex, the need for comprehensive and dynamic clinical supply chain services continues to intensify. The Associate Director, Clinical Supply Capabilities (IRT), will provide broad-based leadership supporting the supply of material to clinical studies. Clinical Drug Supply reports in the Global Supply Chain organization and is full accountable for end to end clinical supplies. We are seeking an experienced candidate to support operations, functions of critical business systems and processes within Biogen's Clinical Drug Supply (CDS) organization. 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.

The Associate Director, Clinical Supply Capabilities plays a critical role in Biogen's Clinical Drug Supply (CDS) organization and sits on the CDS Leadership Team. Responsibilities include managing a team of supply chain professionals to deliver on Biogen's clinical systems including IXRS, Product lifecycle management, temperature monitoring, global change controls, clinical forecasting and developing a digital architecture. This role collaborates closely and strategically with our Asset Teams, Supply Planners, Clinical Development, Quality, Regulatory and Manufacturing teams. A major focus of this role is customer service to improve system integration, governance, communication and business process with stakeholders. In addition, this role supports the delivery of key metrics and reports to the CDS Leadership Team to identify vital trends and/or opportunities. The role will set a digital vision for Clinical Drug Supply, represent CDS in GCP audits/inspections (IRT), 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.

This role will report to the Senior Director of CDS.

What You'll Do

Primary Responsibilities - Business Systems

  • Manage our IRT process including an outsourced Vender Partner model to support the clinical portfolio
    • Participating in vendor account management by reporting and tracking escalated issues
    • Oversee the creation of RFPs for IRT services, upgrade quotes, UATs and IRT delivery timelines.
    • Collaborate with Clinical Development (e.g. Clinical Operations, Statistics, Data Management) and Clinical Drug Supply to capture and document study-specific requirements for the IRT systems
    • Providing support in the troubleshooting and resolution of issues in all phases of the IRT lifecycle
    • Maintain a Digital Strategy, system architecture and five year roadmap for all Clinical Drug Supply systems
    • Acts as subject matter expert for business-critical systems including IRT, PLM, Temp Monitoring, Global Change Control and various R&D Systems
    • The ability to review or develop system strategies to deliver clinical value, quantify risk and develop mitigation strategies
    • Track and routinely report on progress to target for Operational KPIs, Project milestones and identifies areas for improvement
    • Build strong, enduring relationships with stakeholder groups, and act as key escalation point for internal customers, cross-functional partners and ensures CDS representation in various forums (e.g. superuser community)
    • 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.
    • Lead supply chain process improvement and technology implementation within CDS and/or the Global Supply Chain team
    • Provide direction, sponsorship and an escalation point for the team to frame out and execute on key innovation and process improvement initiatives
    • Work with peers on the CDS Leadership Team to develop and maintain a departmental culture that supports innovation, diversity and continuous improvement
    • Supports the effective selection of external vendors and maintenance of those relationships
    • Strong people management skills including coaching, mentoring and development.
    • Managing a team of 2-8 People and an outsource Vendor Service Solution of IRT management.

      Qualifications

      Required Skills
      • B.S. / B.A required
      • Deep knowledge of global supply chain practices
      • Experience working within cGMP supply chain environment. Minimum 12 years of strong business experience in IXRS, System Ownership, or supply chain management.
      • Analytical/Problem Solving - 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.
      • Relationship Management - 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.
      • Leadership and Communication - 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.
      • Technical - Solid knowledge of IXRS, clinical development processes and decision points required. High level of comfort with financial analysis in a portfolio management setting and comfortable evaluating and communicating alternatives based on underlying economic/accounting drivers.
        Preferred Skills
        • MBA
        • APICS certification
        • Experience with GDP, GMP and GCP regulations.

          Additional Information

          Why Biogen?

          Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients' lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.

Keywords: Biogen, Cambridge , Associate Director, Clinical Supply Capabilities (IRT), Executive , Cambridge, Massachusetts

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