Closing Date: 30 Dec 16
Type: Full Time
Salary (£): On Application
Based in Belgium
~~Chiltern is the leading, global mid-sized contract research organization that listens to client needs to deliver customized clinical development solutions. Chiltern’s team of more than 4,200 works across 47 countries to provide flexible, specialized services, with core competencies in Biopharma, Medical Device and Diagnostics, Oncology, Clinical Analytics and Source. Visit www.chiltern.com to learn more about responsive solutions that are Designed Around You®.
We are currently looking for a Clinical Supply Program Manager
Major accountabilities are:
? Define and consolidate a supply strategy to ensure adequate and sufficient forecasting of drug product for assigned programs. 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:
o Ensure constant visibility of CTS department on clinical development plans
o Define/anticipate/influence/optimize packaging design, 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
- Drive and champion department transformation; lead/contribute to projects as needed
- Ability to travel domestically or internationally for business reasons on an as needed basis.
Specific professional/technical expertise and key skills required:
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.
37 bis rue de Villiers, 92200 Neuilly sur Seine, France
|Tel:||+33 1 41 05 73 00|
|Fax:||+33 1 41 05 73 01|
|Website:||Visit Our Web Site|
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