Job Details

• This position is responsible for supporting multiple Clinical Development Programs in a number of therapeutic areas including Oncology, Hematology and Immunology.
• The incumbent is responsible to provide oversight of the supply chain planning and execution of a broad range of clinical trials involving small molecules, biologics and monoclonal antibodies.
• In addition, the Clinical Supply Chain Manager participates on multiple cross-functional project teams with responsibility to communicate clinical supply requirements and provide supply chain expertise as required to ensure project milestones are met.

• In partnership with key stakeholders from Clinical Operations, Medical, Quality and Regulatory oversee the development of a Clinical Supply Plan that documents the study design, product requirements, and study assumptions e.g.
• Enrollment, target countries, number of sites, etc. for each study included in a Clinical Program.
• Oversee the development of the clinical demand forecast on a study and program level and communicate this monthly to the Supply Chain Planning team, as well as key stakeholders e.g.
• Operations, R&D, Project Management, to ensure seamless coordination of demand and supply
• On an ad hoc basis prepare clinical demand/supply scenarios using different combinations of inputs and assumptions to project both short-term and long-term supply availability
• Establish collaborative relationships with Supply Chain counterparts at alliance Partners to facilitate communication, planning and close cooperation in support of Clinical Program requirements
• Partner with Contract Manufacturing (CMO) team members assigned to the project team to ensure close communication and alignment of Clinical Program requirements with production capacities and timelines
• Proactively identify issues with the potential to impact a clinical study and/or program and engage with key stakeholders to highlight risks and find solutions
• Periodically conduct training sessions for key stakeholders and cross functional team members on clinical supply chain processes and procedures as detailed in the Partnership manual
• Lead continuous improvement projects to drive significant increases in operational efficiency and cost reduction

Qualifications:

• University degree (BA/BS) required
• MBA and APICS Certification preferred
• Minimum 8-10 yrs. experience in Supply Chain/Clinical Supply Chain

• Proven leadership skills including leading projects with broad scope, cross functional nature and impact outside supply chain
• Demonstrated ability to simplify complex operational information and ensure understanding of cross functional partners
• Strong analytical and problem-solving skills required for resolving issues in a complex, highly regulated environment
• Excellent communication skills (verbal, written and presentation) with the ability to effectively communicate information and ideas to diverse audiences
• Capable of working in a fast paced environment with limited supervision.
• Candidate must be flexible, adapt quickly and have the ability to manage multiple tasks and priorities
• Experience with Lean/Six Sigma/Process Excellence tools, training and/or certification preferred. Green belt certification preferred
• Ability to embrace change, challenge the status quo and drive improvements to processes and products
• Solid team player with ability to build rapport with team members at all levels of the organization
• Expert knowledge of Excel, as well as extensive experience using it for forecasting, creating demand/supply scenarios, analyzing tradeoffs between business objectives, etc.