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Location

Gif sur Yvette, Essonne | France

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Job description

Servier est un Groupe pharmaceutique international qui aspire à avoir un impact sociétal significatif pour les patients et pour un monde durable. Les 21 800 collaborateurs qui le composent sont engagés autour d'une vocation commune: être engagé pour le progrès thérapeutique au bénéfice des patients.
Clinical Drug Supply Lead

We are looking for a Clinical Drug Supply Lead to join our Clinical Trial Management dept.

You join a global committed team, dedicated to support the operational performance of our international clinical trials

You are responsible for defining and executing optimal clinical drug supply strategies including effective risk management to ensure that drug and ancillary material supply needs and milestones are met in early and late stage clinical development across therapeutic areas

You commit to contributing to the team continuous excellence.

Roles and Responsibilities :

The Clinical Drug Supply Lead ensures drug kits are delivered on time, within budget and in compliance with GXPs, SOPs and standards on assigned projects

He/she defines in collaboration with other stakeholders the most optimized strategy taking into account the technology, regulatory and logistic constraints with the manufacturer

He/She creates forecasts and production plan to guarantee, that the drug supply is in accordance with the project requirements

He/She initiates packaging campaigns with the manufacturer and provide oversight to ensure on-time drug supply to sites or through local depots

He/She manages shipment delivery of drug kits and works with appropriate internal and external parties to address any issues which might impact the timely delivery of supplies

He/She adjusts resupply strategies and production plan to guarantee optimize supply and to reduce wastes by assessing clinical protocol revisions, analysing enrolment rates, inventory usages and trends

He/She supports expiry date management by identifying inventory to BE extended, supporting the extension process

He/She is responsible for setting the IRT and updating IT when needed

Proactively, he/she identifies potential supply chain issues, provides analysis and recommends solutions

He/She coordinates drug return and destruction process

He/She provides input for study documentation (Protocol, Pharmacy Manual, training materials) regarding scope of drug supply management

He/She interacts with CMC teams at project level to anticipate the impacts of CMC activities on clinical drug and ancillary supplies (stability data, in use studies,) and provides CMC with any relevant study information

He/She actively participates in Study Team meetings as the leader and expert for clinical supply activities, providing up-to-date and concise information on study progress from the clinical logistics perspective, identifying important logistic issues that require input from the Team and proposing solutions
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In cooperation with Global Medical & Patient Affairs/Therapeutic Area, he/she ensures the availability of treatments for Initiative Investigational Trial and Compassionate Use Program needs.

Profile :
- Pharmacist, engineer, degree in science or equivalent
- At least 3 years of experience in the field of clinical studies
- Proven experience in managing drug supply
- Proven successful project management & leadership skills
- Very strong organizational and timeline management skills
- Strong interpersonal and communication skills, including the ability to develop and maintain strong relationships within the Study Team and international study personnel
- Strong capability to proactively identify risks and apply problem-solving skills
- Ability to manage multiple tasks in a dynamic environment with shifting priorities
- Excellent knowledge of English (writing and speaking)

This is a full-time, permanent position at our headquarter in Suresnes, located from May 2023 onwards at our new international R&D campus in Saclay.

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