Clinical Supply Operations Team Lead, China

Business Description

This people leader role is responsible for overseeing a group focused on end-to-end supply chain management of clinical supplies.

Through the team, she/he ensures supply operation strategies are developed that support the Therapeutic Areas and Clinical programs and trials to ensure on time delivery and optimal supply overage for API, DP and Packaged materials.

This position provides effective functional supervision to support J &J 's success in conducting clinical trials of the highest quality, as well as trial issue management and resolution for the assigned TA/DAS area.

This role aligns, tracks and reports out budget management at a group and compound level.

Description of the Role

• The main responsibilities of the function holder are to

- Provide strategic and operational leadership, manage functional and compound budget and resource allocation in the Clinical Supply Management consistent with R&D objectives and timelines in China .

• R esponsible for:

- Acts as the clinical supply chain project and team leader for one or more compounds.

Drives team problem solving and acts as a coach to team members to drive their technical and personal development.

- For each compound, takes leadership over the escalation and (as appropriate) resolution of critical risks and issues.

Ensures there is a well-designed integrated demand and supply plan from API to Kit.

Leads S&OP escalation topics with limited or no guidance.

- 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 activities required to meet First-Patient-In date of clinical trials in China .

This includes initial demand forecasting, configuration of the distribution network, IVR / RTSM specifications, kit and label design, and developing supply strategies to meet clinical plans while optimizing drug overage.

Influences decisions in therapeutic areas from a clinical supply chain perspective.

- Develops and manages the clinical supply budget for trials and programs (internal FTEs as well as OOPs, excluding API and DP)

• Act as Clinical Supply Chain champion in collaborative efforts with external companies (e.g., due diligence efforts, clinical development partnerships).

• Develops strong collaborations with the TAs, GCO, and DPDS and other Operational Heads to ensure customer satisfaction.

• Represents Clinical Supply Chain for a particular compound and for various processes during GCP and GMP health authority inspections or escalations.

• Is the sponsor and identifies sponsors or leads innovative projects to significantly improve functional and cross functional processes and tools.

• Exemplifies and drives the use of core processes and tools in the department and the teams and serves as a mentor to others to drive adoption.

Creates clarity in roles and responsibilities and holds teams s...