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Clinical Pharmacologist (MP) - All Gender

CDI
Montpellier
Salaire : Non spécifié
Télétravail non autorisé

Sanofi
Sanofi

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Le poste

Descriptif du poste

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.

CONTEXT

Sanofi R&D is looking for clinical pharmacologists for R&D centers in Montpellier (South of France) or Chilly-Mazarin (Paris area).

Sanofi is a leader Company in Global Healthcare that discovers, develops, produces and markets innovative therapies to help protect health and enhance people's lives. Sanofi currently develops a pipeline of more than 80 compounds (biologics and small molecules), with specific focus in oncology/immuno-oncology, immuno-inflammation, neurology and rare diseases.

We are hiring clinical pharmacologists to join the Translational Medicine-Clinical Pharmacology (TM-Clin Pharm) department in Translational Medicine and Early Development (TMED) platform. TM-Clin Pharm is a global department interfacing with both Research and Development Groups focusing on the Therapeutic Areas of Immuno-Inflammation (I&I), Neurology, Rare diseases and Rare blood disorders. The main mission of TM-Clin Pharm department is to contribute to the biomarker and translational plan for projects coming out of Research, and to provide an early clinical development plan from first-in-human studies up to the proof-of-mechanism and/or the proof-of-concept studies before embarking on the late clinical development. The department is then responsible for designing and overseeing the execution of these early phase studies. For all these activities, TM-Clin Pharm department works closely with Precision Medicine, Clinical Pharmacokinetics and Pharmacometrics, Biomarkers and Clinical Bioanalysis, also part of TMED platform. The individual in this position is member of the global project team, often leading the cross-functional Translational Medicine Subteam from preclinical development through post-marketing. Collaborative interactions with various stakeholders (e.g., laboratory research scientists, toxicologists, pharmacokineticists, modeling and simulation experts, biomarker experts, pharmacovigilance experts, and late phase therapeutic area clinicians) are critical to success in the role. The ability to integrate the outputs of multiple disciplines into a coherent translational medicine plan is essential.

KEY RESPONSIBILITIES

At the project level, as TM-Clin Pharm Lead

  • Participates in designing the early development plan and overall translational medicine and clinical pharmacology plan for the different steps of clinical development, according to the strategy developed by the responsible Therapeutic Area
  • Designs and supervises the conduct of safe, rapid and informative First-In-Human studies, streamlined Proof-of-Mechanism/Proof-of-Concept studies providing robust data for early Go/No Go decisions and other pharmacokinetic and mechanistic studies
  • Reviews, interprets results, and authors translational medicine and clinical pharmacology-related clinical documentation, including clinical protocols, study reports, some abstracts and/or manuscripts, clinical pharmacology components of investigator brochures, regulatory documents
  • Interacts effectively with managers from various disciplines; serves as expert and internal consultant on assigned area and liaises with partners on projects
  • Leads the translational medicine subteam meetings
  • Coordinates activity of the study medical managers(s) of assigned project(s)
  • Participates in the dose selection for first-in-human studies, Go/No Go decisions when needed
  • Ensures an adequate follow-up of studies and project timelines
  • Communicates project team discussions of interest to the other group members who are involved with the project
  • Presents data in appropriate meetings (inside or outside the Group)

At the clinical study level, as Study Medical Manager

  • Study preparation
    • Designs, and conducts early clinical development studies within planned timelines (supported by an operational team)
    • Reviews and approves study documentation (case report forms, monitoring plan, statistical analysis plan, contracts, regulatory documents, etc.)
    • Coordinates clinical team to set-up and follow the study
    • Ensures proper documentation is provided to the Ethics Committees and Health Authorities
  • Study conduct
    • Ensures that the study is scientifically sound and correctly conducted
    • Prepares and reviews the interim investigator reports
    • Provides documents for making decision to start next dose level (for First-in-Human studies)
    • Reviews the Serious Adverse Event reports
  • Study validation and reporting
    • Participates in the data review and validation meetings before database lock
    • Reviews and interprets the results
    • Prepares and distributes the Key Results Memo and prepares/reviews the Clinical Study Report

Major Challenges and opportunities

  • Communication of the role of the department; requires a committed and enthusiastic person to emphasize the strengths of the position and a positive, collaborative attitude
  • Takes an active part in the scientific challenges involved in early clinical development, which require a scientifically inquisitive, energetic and proactive person
  • Ensures Clinical Trial standards are maintained at the site and in cooperation with the other clinical functions. Requires excellent communication skills and the implementation of an appropriate process for communication
  • Ensures high quality documents, requiring strong writing and communication skills
  • Manages aggressive timelines effectively through cross-functional planning

Key Internal/External Relationships

  • Internal contacts: Early Development Operations (EDO, including Global Study Managers and Data Managers), Biostatistics, Preclinical Safety, Regulatory Affairs, Global Pharmacovigilance, Therapeutic Area Research and Development Groups
  • External contacts: Investigators, early phase clinical research organizations, clinical trial vendors, clinical and scientific experts, ethics committees, health authority representatives

Decision Making Authority

  • Makes front-line decisions on protocol design, execution, dose escalation and safety, information for regulatory authorities

PROFILE

Basic 

  • Doctor of Medicine
  • Strong scientific background
  • Experienced in conducting clinical trials
  • Excellent communication and inter-personal skills
  • Fluent in English

Preferred

  • Postgraduate experience, laboratory research in industry or academia is a plus
  • Broad biomedical knowledge base
  • Advanced knowledge in immunology
  • Knowledge and mindset in translational research
  • Able to acquire and apply new technical skills
  • Leadership skills and experience

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.

As part of its diversity commitment, Sanofi is welcoming and integrating people with disabilities.

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