PM Clinical Supplies

Reference: HAR-15-042

Client

Our client is a global top 10 pharma company located at the east side of Antwerp.

This function is office based.

Main purpose

This matrix team leader is responsible for end-to-end supply chain management of clinical supplies aligned per Therapeutic Area. Through the CSC Technical 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 level and influences the right trial design and its operational impact.

Tasks

  • Acts as the clinical supply chain project and team leader for one or more compounds. Leads the Clinical Supplies subteam, and through the team orchestrates all clinical supply activities to successfully deliver a clinical program. Guides the team problem solving and provides some coaching to junior team members.
  • For each compound, leads the monthly cS&OP cycle and 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 guidance from the supervisor.
  • Represents the Clinical Supply Chain at the CMC team and drives the CMC planning, coordination, and decision related to clinical supply activities (API, DP, Kit) to ensure uninterrupted supply for clinical programs and trials.
  • Represents PDMS at the Clinical team. 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. 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.
  • Manages the activities required to meet First-Patient-In date of clinical trials. 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. Ensures seamless transition to the Trial Supply Manager and provides oversight and support through execution phase of trial.
  • 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 parterships.
  • Develops strong collaborations with the TAs, GCO, and PDMS to ensure customer satisfaction.
  • Participates in GCP and GMP health authority inspections.

Requirements

  • University/Bachelors Degree plus 5+ years related experience Or Masters Degree plus 2+ years related experience
  • Very strong clinical supply design expertise (e.g., influencing clinical protocols, designing patient kits, developing distribution strategy)
  • Demonstrates an operational understanding of the E2E Supply Chain and process and uses the knowledge in the job
  • Strong knowledge of pharma/ bio research and development, end-to-end supply chain management, clinical supply logistics and distribution
  • Good knowledge of clinical research and operations and ability to consolidate and manage overall clinical supply demand
  • Excellent knowledge of CMC drug development process and roles
  • Strong knowledge of GXP
  • Excellent knowledge of RTSM (IVRS) functionality
  • Good knowledge of project management and demand tools
  • Good use of clinical supply demand simulation tools required (e.g. Optimizer)
  • Proven financial expertise including knowledge of financial systems
  • Minimum 80% FTE required
  • Strong project management skills
  • Strong communication and influencing skills
  • Very strong matrix team leadership skills
  • Big picture orientation with attention to detail
  • Ability to collaborate internally and have seamless partnership
  • Ability to work in cross cultural environment
  • Strong strategic thinking skills

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