Mission pourvue
Descriptif de la mission
We are a global biopharmaceutical group dedicated to improving lives and health outcomes through innovative medicines in Oncology, Neuroscience and Rare Disease. We are committed to discovering new treatments in areas with high unmet medical needs and improving the quality of life for patients.
Research and development are key elements of our strategy, reflecting our commitment to improving patients’ lives and health outcomes. Bolstered by a culture of collaboration & excellence, we offer a unique proposition to 5,700+ employees committed to society.
The Pharmaceutical Development organization is located across 5 Sites (France, UK, Ireland, US and Canada). The position is global and currently located in Europe. Regular presence at the Dreux site is expected.
In respect to Good Manufacturing Practices and as part of the Global Clinical Supply Management department (GCSM), the clinical supply chain therapeutic area (TA) lead
• ensures with his / her team the set up and the management of the supply chain related to our clinical trials
• performs his / her mission according to (i) the up-to-date internal and external regulatory guidance and process, (ii) and within time, resources and cost agreed by the company.
This entails to be strongly involved in the continuous improvement process and knowledge management relating to the development of NCEs and Life cycle management of commercial products within the DPD department.
Main responsibilities / job expectations
Leadership responsibilities
- Lead a team in a matrix and global environment,
- Support in the definition of the annual objectives of his/her group in alignment with the objectives of
Pharmaceutical Development & R&D. Lead his/her team by mobilizing it around its objectives and
evaluates the outcomes,
- Provide effective and continuous feedback to its team to reward and ensure development discussions,
- Support in the definition of the training/development plan for his/her team, ensure its implementation
and carry out the follow-up.
TA Supply Chain Lead responsibilities
- Represent GCSM in CMC project meetings and ensure adequate alignment with Asset Teams objectives
(timelines, priorities, need to initiate / review forecasts, communication escalation, anticipate risks and
provide mitigation). Develop close collaboration with CMC Leads.
- Represent GCSM within Clinical Operations strategic meetings and ensure seamless alignment with
clinical development programs (overall plan including all studies of the program, study design
assumptions etc)
- Define and maintain long term clinical packaging and distribution plans (time and quantities) to facilitate
strategic decisions (make versus buy, activities prioritization)
- Lead, influence and support a team in charge of the set-up of clinical studies from a supply chain
perspective:
o FacilitateacrossfunctionalCMCsubteamwhichincludesoperationalqualityassurance,clinical
packaging and distribution for internal projects and CDMO management for outsourced projects
o Developwithitssubteamcomprehensiveprojectplanstoensureontimesupplytopatientsand avoid IMPs stock out
o ProposethedesignoftheIMPkitsinpartnershipwithpackagingteamorCDMO
o Managethelabellingdefinitionandapproval
o Createandmaintaincomprehensiveprojectdocumentation(IMPDesignandSupply/Handling
Manual / Supply Chain Flow Diagram)
o ReviewClinicalOperationsdocumentation(CROscopeofworketc) o Ensureallstudiesforecastsarerevisitedonaregularbasis
o Conductsupplychainrisksanalyses
- Review and approve IMP Design and Supply documentation / Handling Manual / Supply Chain Flow Diagram
- Ensure alignment of budget between CMC teams and CDMO management team
- Based on a tight collaboration with the Portfolio Management and Processes team as well as CDMO
Management team, ensure harmonized ways of working / processes are applied within GCSM
department
- Present the results and progress of projects under his/her responsibility at internal / external meetings
Continuous improvement responsibilities
- Contribute to continuous improvement projects within the GCSM and/or wider Pharmaceutical
Development.
- Be a promoter of continuous improvement processes and to guarantee the method.
QEEHS Responsibilities responsibilities
- Respect and uphold the Good Practices applicable (BPF, BPD, ...), the rules of Energy Environment Health and Safety through the procedures applicable within the company.
Critères requis
Education / Certifications:
• Pharmacist, engineer, degree in science or equivalent ideally with a PhD in science
Experience:
• 7-10 years’ experience in an equivalent job in the Pharmaceutical Industry with a significant
international exposure
Languages:
• Proficient in French and English
- Experience and knowledge on handling large and complex clinical trials (preferred)
- Excellent communication skills / networking
- Experience in project management
- Team player with ability to work in a matrix environment
- Strong organizational skills