Success Profile

Courageous
Results-driven
Proactive
Problem-Solver
Leadership
Team player

The Vaccine Trial Supply Operations manager (VTSOM) is a key member of the Clinical Supply Chain (CSC) department. During the set-up phase of the clinical trial, his/her main accountability is to coordinate and ensure the worldwide delivery of the product (IMPs and AxMPs) from manufacturing sites to clinical sites, labelled and packed according to the clinical protocol and in alignment with regulatory requirements. During the conduct phase of the clinical trial, his/her main accountability is to secure IMP resupply until final reconciliation (including return and destruction).

The VTSOM responsibilities include but are not limited to

• define the best Labelling and Packaging (L&P) specifications and scheduling,

• coordinate the L&P activities till SQO IMP release

• contribute to the randomization specifications and Interactive Responsiveness Technology (IRT) configuration,

• coordinate IMPs distribution, returns and destruction,

• and finally, coordinate the trial products reconciliation.

The VTSOM guaranties that all supply chain operations are performed in respect of the regulatory requirements, Sanofi procedures (SOPs), clinical protocol and related timelines.

The Vaccine Trial Supply Operations Manager (VTSOM) operates in an international environment.

The main challenges of the VTSOM position are

• Work in complex regulatory environment

  • GMP: filling & packaging operations, shipping unit, quality operations

  • GCP: clinical operations departments, local clinical teams, quality operations

  • Other: Regulatory affairs, purchasing, supply chain

• Adhere to aggressive timelines

• Collaborate with multiple internal and external collaborators and vendors around the world

• Anticipate and mitigate a multitude of logistics risks (vaccine expiry dates, cold chain breaks, protocol amendments, planned versus actual recruitment rates variances, active and inactive sites)

• Provide comprehensive trial progress status to internal and external stakeholders,

• Solving issues mindset

  • Be able to negotiate and tend to agree with win-win solutions considering other functional areas drivers staying aligned with company and clinical objectives, and respecting quality and performance indicators.

  • Promote efficient solutions to routine or unexpected more or less complex issues in the field of the product management

• Be able to respond to unexpected/urgent demand or change

• Maintain blind information till database lock for blinded trials

• Take actions and decisions with substantial impact on overall project budget.

• Manage many different interfaces across different quality referential

The VTSOM key accountabilities are

• Ensures optimal vaccines supply operations (labelling, packaging, randomization, shipment and destruction)

• Ensure effective communication (Lead CSC KOM and Operational Supply Meetings (OSM), participates in Clinical Team Meetings (CTM), and maintain accurate data in several tools).

• Develops actively skills and expertise (can act as Subject Master Expert on tools and processes)

• Contribute to the CSC process optimization by leading or participating in CSC transversal initiatives (at vaccines or pharma level) or within other departments (clinical or quality)

Requirements

Position Requirements

• Travel: Expected travel to office in France up to 2x annually

Education/Experience

• Bachelor of Science degree (BS) in Health Science, engineering or related discipline. Demonstrated ability to work in complex settings

• At least 5 years’ experience in pharmaceutical business required, preferably within supply chain, clinical operations or manufacturing environments

• The individual should be well versed in several of the following aspects: supply chain management, GMP, GCP, GDP.·

Skills (General)

• Thorough scientific understanding of filling, labeling/packaging and associated regulations.

• Experience with worldwide logistics and/or supply chain management. Exposure to clinical trial operations or regulations would be a plus.

• Excellent oral and written communication skills to include presentations in support of training on new procedures. High attention to detail.

• Excellent negotiation skills. Strong problem-solving skills.

• Excellent ability to multitask and prioritize workload within a dynamic, timeline driven, culturally diverse organization; effective time management skills.

• Exercises calm, sound constructive judgment during high demanding situations.

Skills (Tools)

• MS Office solutions (word, excel, PowerPoint, Excel, Outlook)

• Interactive Responsiveness Technology (IRT) like Endpoint / Suvoda

• Documentation management systems and Quality management systems

• Collaborative platforms (SharePoint / Teams)

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

As a healthcare company and a vaccine manufacturer, Sanofi has an important responsibility to protect individual and public health. All US based roles require individuals to be fully vaccinated against COVID-19 as part of your job responsibilities.

According to the CDC, an individual is considered to be “fully vaccinated” fourteen (14) days after receiving (a) the second dose of the Moderna or Pfizer vaccine, or (b) the single dose of the J&J vaccine. Fully vaccinated, for new Sanofi employees, is to be fully vaccinated 14 DAYS PRIOR TO START DATE.

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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.