Clinical Supply Program Manager
Duration of the assignment:1 year
Start date (est.): ASAP
Start date (est.): ASAP
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
- Drive and champion department transformation; lead/contribute to projects as needed
- Willing to travel domestically or internationally
- 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
- 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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