Associate Director Clinical Supply Integrator

仕事内容

This matrix team leader is responsible for end-to-end supply chain management of clinical supplies. Through the Clinical Supply Sub-Team develops supply strategies matching needs of clinical programs and trials to ensure on time delivery and optimal supply overage for API, DP and Packaged materials. Manages budgets at a compound or trial level and influences key stakeholders (Therapeutic Area (TA), Clinical Team, CMC Team) on the trial design and its operational impact. May act as a matrix team leader or people manager, this individual is responsible for overseeing a group focused on end-to-end supply chain management and works with a high degree of autonomy and independence.

Description of the Role:

- Sets direction as the clinical supply chain project and team leader for one or more complex/accelerated 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 managing change, challenging the status quo, and problem solving. 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, including communication to key stakeholders. Ensures there is a well-designed integrated demand and supply plan from API to Kit. Leads cS&OP escalation topics with little to no guidance from the supervisor.
- Represents 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.
- Develops strong collaborations with the TAs, GCO, and CPDS to ensure translation of customer needs to fit-for-purpose. Potentially act as SPOC (Single Point of Contact) for TA’s & GCDO aligned per Therapeutic Area contributing to due diligence efforts, clinical development partnerships, Medical Affairs, Single Patient Requests, Named Patient Programs/Early Access Programs).
- Represents CPDS 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, escalates & communicates to the clinical team as needed.
- 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.
- Participates in GCP and GMP health authority inspections.
- Contributes to some degree to strategy development at the functional level and drives structured improvements of functional processes (quality, cost, time, asset utilization) in line with business or operational strategy. May set direction on promotions, recruitment strategy, and team structure.
- Mostly interacts with internal stakeholders, occasionally with external.
- Manages limited number of complex projects with potentially accelerated priority.