Clinical Supply Program Manager – Braine l'alleud, Belgium

Clinical Supply Program Manager

Duration of the assignment:1 year
Start date (est.): ASAP

Responsibilities:

The CSPM has the CTS accountability at program level (for assigned programs) and acts as (1) a strong and visible partner for Technical/Clinical Development representatives, actively driving trial/packaging design and supply chain optimization, and ensuring full visibility of CTS on clinical development plans/compound information; (2) a program matrix leader within CTS, overseeing trial supply execution & driving risk/budget management through other functions (in particular Clinical Supply Manager/Clinical Supply Associate).
Scope: All compounds and related clinical trials (phase 1-4) + Expanded Access Programs with CTS involvement
 
Products: All products of our client
 
The CSPM acts as (1) a strong and visible partner for Technical/Clinical Development representatives, actively driving trial/packaging design and supply chain optimization, and ensuring full visibility of CTS on clinical development plans; (2) a program matrix leader within CTS, overseeing trial supply execution & driving risk/budget management through other functions (in particular Clinical Supply Manager/Clinical Supply Associate). Major accountabilities are:

  • Define and consolidate an appropriate supply strategy to ensure optimal forecasting of drug product/comparators/IMP, as well as optimized supply chain management throughout the trials.  Create and maintain high level supply plan for all upcoming trials as soon as created in EPPM (Enterprise Project & Portfolio Management system), until Clinical Supply Manager assignment.
  • Compile the forecasted trial budgets into a compound budget and provide regular updates through the budget exercises.
  • CTS interface for the Technical Lead and Clinical Program Director/Lead Clinical Development Representative, fostering a close partnership, to:
    • Ensure constant visibility of CTS department on clinical development plans
    • Define/anticipate/influence/optimize packaging design (including patient value considerations), lead times, clinical, regulatory and technical aspects of upcoming clinical trials.
  • Represent CTS in CST (Clinical Satellite Team) meetings (or equivalent, potentially to be initiated by CSPM) and ensure CTS requirements and expectations are met (e.g. drug product shelf-life, CTS related timelines, bulk availability, IRT and country selection …) and be able to influence decisions taken during those meetings.
  • Represent CTS in TST (Technical Satellite Team) and address requirements for CMC related activities (e.g. development of formulation, stability program, shelf life extension etc.)
  • Drive or suggest compound-level improvements/alignment within CTS or with Partners like Technical Leads and Clinical Program Directors
  • Share key information/decisions/results from CST (Clinical Satellite Team) and TST (Technical Satellite Team) with other CTS functions
  • Ensure availability of compound information and knowledge in CTS (e.g. formulation types, manufacturing sites, shelf life, clinical and technical challenges)
  • Lead and maintain structured oversight on clinical trials (forecasted and on-going) per compound to ensure no supply chain disruption and adequate budget, providing guidance and support to other CTS functions/Global Distribution & Logistics/QA as needed
  • Provide input for comparator sourcing

 
Others:

  • Drive and champion department transformation; lead/contribute to projects as needed
  • Willing to travel domestically or internationally

 
Your profile:

  • Master’s degree in sciences and minimum of 5 years of CTS relevant experience (in pharmaceutical manufacturing/packaging, clinical trials and/or supply chain.
  • Knowledge of GxPs
  • Financial skills
  • Project management
  • Supply chain management
  • Communication & Presentation skills (English fluency)
  • Influence, negotiation, driving CTS visibility/impact
  • Networking, collaboration
  • Coaching, matrix leadership, driving results through people
  • Accountability
  • Proactivity & Risk management
  • Agility, change champion
  • Holistic/strategic thinking
  • Creativity, innovation
  • Ability to solve issues, to assess risks and prevent issues for assigned projects.
  • Address areas for improvements, propose creative solutions, support development and implementation of improvements.
  • Ensure cross-functional root cause/impact analysis and action plan.

 

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