Job Description

The Manager, Clinical Asset Planning plays a critical role in Biogen’s Clinical Drug Supply (CDS) organization, responsible for ensuring continuous product supply for our global clinical trials by collaborating closely and working strategically with our Asset, Clinical Development, Quality, Regulatory and Manufacturing teams.  The successful candidate will oversee the end-to-end clinical supply chain and manage the forecasting, manufacturing, risk management and expiry management plans for multiple clinical assets. This role will report to the Associate Director of CDS.

PRIMARY RESPONSIBILITIES:

• Maintaining supply continuity for Biogen assets across multiple global trials:
• Accountable for the availability of API/DS/DP and FGI across all protocols.
• Completing and maintaining Rough Cut Capacity Plans for API/DS/DP and FGI
• Execute API/DS/DP and FGI clinical product lifecycle maintenance
• Develop and maintain API/DS/DP and FGI demand and update relevant systems
• Act as a key liaison between the Asset Teams and Clinical Development teams, ensuring that clinical supply and demand is aligned with the Clinical Development Plans
• Collaborate closely with the Clinical Supply Managers to ensure alignment of APD/DS/DP production individual protocol-level Finished Goods forecasts and develop strategies for delivering the product globally
• Provide guidance and support to the Clinical Development Team in understanding the impact of Study Design on the clinical supply chain
• Support supply chain process improvement and technology implementation initiatives

Qualifications

Applicants will be highly detail oriented with excellent communication and presentation skills.  Applicants should have a minimum of 5-7 years of supply chain planning/management experience in the pharmaceutical or biotech area.  We require a minimum of a Bachelor’s Degree in Supply Chain Management or Science-based Discipline.

We are interested in hearing from candidates with a proven track record of success in the following areas:

• Effective collaboration across multiple stakeholders in developing and implementing effective supply chain management strategies. 
• Developing forecasts and supply plans for IMPs incorporating expiry management and accounting for complex regulatory requirements. 
• A solid understanding of drug and process development across modalities (large molecule, small molecule, ASOs, gene therapy) – or – a solid understanding of clinical trial development across all phases (R-to-D transition, phase 1, 2, 3 studies), and the implications for either on supply chain planning and execution.
• Leveraging tools and systems to manage demand and inventory.
• Proven ability to develop and train more junior team members.
• Ability to work with diverse learning and working styles to leverage strengths.
• Preferred: APICS certification and clinical supplies planning and forecasting experience

Additional Information

All your information will be kept confidential according to EEO guidelines.