Le contenu du poste est libellé en anglais car il nécessite de nombreuses interactions avec nos filiales à l’international, l'anglais étant la langue de travail.
At Sanofi Consumer Healthcare, we have one shared mission – we work passionately, every day, to ‘serve healthier, fuller lives’ now and for the generations to come.
In order to do so, we strive to act as a force for good by integrating sustainability along our business and employees’ mission and operate responsibly from both a social and environmental point of view.
Everything we do is centered around people’s interests – our consumers, our customers, healthcare professionals, and our employees – across the world.
We are building loved brands that serve 1bn consumers worldwide, through our key platforms: Allergy, Physical & Mental Wellness, Pain, Digestive Wellness and Cough, Cold & Flu.
We aspire to become the best Fast Moving Consumer Health (FMCH) company In & For the world and we aim to build a work environment where people can thrive, grow, enjoy and be at their best.
The Consumer Healthcare (CHC) Clinical Operations team is an end-to-end clinical study capability serving the CHC GBU. Our scope is all CHC countries and indication areas. We shape high level evidence generation concepts into clear clinical study strategies. The function then uses a full outsourced model to work with CROs and service providers that plan and execute all studies using an outsourced model. We are a purpose-built Clinical Capability with an objective to be the best clinical capability in the industry within the next 3 years.
Given the criticality of clinical study supplies for interventional clinical studies, we have a leadership role focused on designing and delivering a reliable clinical study supplies capability – the Clinical Studies Supply Head (CSSH). The CSSH reports to the Global Head of Clinical Operations. This role leads an outsourced clinical supply capability to support the entire CHC GBU needs.
The CHC Global Clinical Study Supply Head (CSSH) is a global functional head role that is responsible for leading and coordinating the GBU’s end-to-end clinical supplies strategy. This leadership role ensures the GBU has a reliable and efficient Clinical Supply capability.
An existing framework of clinical study supplies providers has been established. However, the CSSH will be responsible for ensuring the model evolves as our priorities shift and new strategic opportunities are presented.
The CSSH works cross-functionally in close cooperation with clinical supplies quality, clinical operations, medical experts, clinical quality, regulatory affairs, pharmacovigilance, and CHC development center and scientific innovation teams.
The CSSH also works at the study level as part of the clinical study team to oversee the development and delivery of clinical study supply needs for individual studies. The CSSH will work on clinical study programs ranging from study set-up, conduct and close-out, complying with GCP, cGMP and applicable regulatory guidance.
The high level CSSH’s role is to:
- Be the CHC GBU leader that defines and implements the overall functional and service provider architecture in pursuit of a reliable and efficient GBU Clinical Supply service provider network:
- Strategically define the GBU functional needs and Clinical Manufacturing Organization (CMOs) architecture for clinical supplies
- Identify and select CMOs. Work with the CHC quality team to qualify the CMOs
- Facilitate the drug product bulk flow management in cooperation with CHC manufacturing sites and CMOs/CROs. Coordinate placebo production and distribution logistic with CMOs and/or CROs
- Lead training efforts on clinical supply processes for internal stakeholders
- Provide comprehensive clinical supplies expertise to the CHC GBU
- Provide leadership and line management to the Clinical Study Supply Manager role
- Work with project teams and CMOs/CROs to ensure individual projects clinical supplies needs are anticipated, produced, delivered to site, at the right quality level and are finally destroyed at the end of study in line with regulatory requirements:
- Develop study level calculations for clinical supply and/or devices’ including identification of critical path, timelines and budgets in cooperation with external CMOs/CROs and internal key stakeholders, e.g., clinical supplies quality, clinical study team, CHC development centers
- Source the appropriate CMO and execute clinical supply CMO/CRO agreements with respect to contracted scope of work and budget
- Facilitate the drug product bulk flow management in cooperation with CHC manufacturing sites and CMOs /CROs
- Coordinate CMOs/CROs including placebo production, packaging, and distribution
- In close cooperation with CHC development centers, regulatory and external CMOs/CROs, ensure that the label text for clinical supplies and/or devices follows international regulations
- Act as key user for clinical supplies IT systems and oversee the set-up of Interactive Response Technology (IRT) systems with the CMO/CRO, if required
- Manage the filing and archiving of clinical supply related documentation for the Trial Master File (TMF) in close alignment with the global study manager and CMO/CRO
- Improve processes to constantly make the clinical supplies provision process faster, more cost-effective, and reliable:
- Create or revise CHC Global Quality Documents (e.g., Standard Operating Procedures) and process descriptions in clinical supply/device management
- Support process improvement initiatives and digital transformation activities in the clinical operations area towards an innovative evidence generation organization (Digitalization/virtual studies/new evidence generation approaches)
- Required Experience
- Experience in leading global clinical studies including a working knowledge of international regulations/Guidelines/Good Practices pertaining to the clinical domain (ICH-GCP, cGMP etc.)
- Managing clinical supplies activities covering all study periods from start-up over study report, to archiving of required documentation in the electronic Trial Master File (eTMF)
- Managing multiple projects including CMO/CRO oversight and quality/compliance issues
- Managing and overseeing budgets
- Desired Experience
- Experience managing CMOs for development of clinical supplies
- Management of CROs and study specific CMOs for clinical supplies and strong interpersonal skills
- Pragmatic and innovative solutions architect for clinical supplies management
- Experience in Consumer Health Care (CHC)
- Soft Skills
- Strong leadership and project management skills in a global environment (coordination, timelines, budget oriented)
- Technical Skills
- Experience in a GxP regulated area of a pharmaceutical or device company or CRO
- Creating and revising quality documents and process descriptions
- Knowledge in working with clinical supplies related IT systems and coordination of Interactive Response Technology (IRT) systems in alignment with CROs/CMOs
- Profound knowledge of MS Office 365 (i.e. Word, Excel, PowerPoint, Teams, SharePoint etc.)
- Education: Bachelor level degree in life sciences or related fields plus a minimum
- Languages: Fluent spoken and written English
Pursue progress, discover extraordinary
Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: A desire to make miracles happen. So, let’s be those people.
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At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.