Ref #: 25468

Employment type: Permanent - Full-Time

Location: US - East Coast

Posted: 08-Jan-2021


• Sets direction as the clinical supply chain project and team leader for one or more compounds, from NME to Life Cycle Management. Leads the Clinical Supplies sub team, and through the team orchestrates all clinical supply activities to successfully deliver a clinical program. Drives a global team in defining and driving change, challenging the status quo and problem solving and provides coaching to team members. Independently manages issue escalation and resolves compound issues with limited guidance.
• For each compound, leads the monthly cS&OP cycle and takes leadership over the escalation and (as appropriate) resolution of critical risks and issues, include communication to key stakeholders. Ensures there is a well-designed integrated demand and supply plan from API to Kit. Leads cS&OP escalation topics.
• Represents the Clinical Supply Chain at the CMC team and the Clinical team leading the product strategy. Communicates and executes the strategy and development plan with high level of autonomy and accountability. Accountability for CSC planning, project budgets, coordination, and decisions related to clinical supply activities resulting in uninterrupted supply.
• Represents DPDS at the Clinical team, ensuring clinical strategy can be executed. Influences the clinical teams in the trial design and operational aspects thereby ensuring cost efficiency and customer satisfaction, and coordinates escalation & communication to the clinical team.
Manages the compound activities required to meet key CSC/CMC/CT milestones. This includes long range demand forecasting prior to transition to TSM, selection of formulation and comparators used in clinical trials, and developing supply strategies to meet clinical plans while optimizing drug overage.
• CMC Drug Product Development - Demonstrates in-depth knowledge of E2E CSC activities and the broader development process/organization in order to support the development G&O’s with impact on departmental strategy.
• E2E CSC accountability for portfolio projects at the CMC and clinical teams, managing internal and external stakeholders.
• Matrix Team Leader – Leads the CSC sub- team applying innovative approaches and out of the box thinking while providing coaching to help develop the team members.
• Quality – Ensures project activity, which is safe, effective and otherwise compliant with global health authority expectations.
Problem Solving / Decision Making - Creates a culture and empowers others in the analysis of strategic problems and issues; identifies and manages the impact across the business.
• Project Management - Leads multi-dimensional projects across the business; manages the inter- relationships among projects for optimal outcomes, processes, and people.