R&D-Early Development Medical Scientist and Translational Medicine Expert-Shanghai\Beijing

Job description

JOB PURPOSE:

This position is in Translational Medicine and Clinical Pharmacology, the global department functioning across all of the therapeutic areas at Sanofi and with a scope that includes performing early development clinical trials for small molecules, biologics, and other therapeutic modalities. This department is part of the TMED (Translational Medicine & Early Development) group in R&D Development. The individual works with global project teams to develop the strategy for timely clinical development for the compound with a focus on the requirements in Asia, as well as with local teams to execute the development strategy, conduct clinical studies, and support regulatory interactions.  Development of a regulatory strategy, in conjunction with regulatory colleagues, is an important component.  A key aspect of this position is medical and scientific supervision and management of clinical trials performed by the Translational Medicine & Clinical Pharmacology group.  The individual functions as the study medical manager for Phase 1 to 2 clinical studies that are related to projects in clinical development and for marketed drugs.  Collaborative interactions with pharmacokineticists, laboratory research scientists, toxicologists, modeling and simulation experts, biomarker experts, and therapeutic area clinicians are critical to success in the role. 

The individual will provide support to the global project team by providing expertise on clinical development and regulatory interactions in Asia, as well as local support to clinical and regulatory interactions. 

KEY ACCOUNTABILITIES:

·  Significantly contribute to the Asia strategy of global product development by providing expertise on early clinical development requirements in Asia, especially any country-specific requirements
·  Provide medical and scientific management for a clinical study (from study design to final study report), including coordination of the clinical study team to set up and follow the study, and ensure correct conduct of the study
·  Develop a regulatory strategy for studies/compounds (in conjunction with regulatory colleagues) and interact with local teams to support regulatory requirements and interactions
·  Design safe, scientifically sound clinical studies, including the biomarker and translational medicine plan
·  Work closely with pharmacokineticists on clinical study design and strategy
·  Review and approve study documentation (case report forms, monitoring plan, statistical analysis plan, contracts, documents for Ethics Committees/Health Authorities, etc.)
·  Prepare and/or approve documents related to the study and requiring scientific/medical expertise (extended synopsis, protocol, medical training material for study monitoring team and for investigators, etc.)
·  Provide medical training and serve as medical contact to study team, CSUs (Medical Advisors, monitoring, etc.) and investigators
·  Interact effectively with managers from various disciplines; serve as expert and internal consultant on assigned area and liaise with partners on projects. 
·  Review and interpret results, including safety data, Serious Adverse Event reports, and data review and validation meetings before database lock
·  Author translational medicine and clinical pharmacology-related clinical documentation, including clinical protocols, key results memo, clinical study reports; abstracts and/or manuscripts; clinical pharmacology components of investigator brochures, regulatory documents, etc.
·  Ensure an adequate follow-up of studies and project timelines. 
·  Present data in appropriate meetings (inside or outside the Group).
·  Support the CSUs and affiliates to develop a network of KOLs and experts and to select National Coordinators or members of Study Committees
·  Serve as medical contact for inspections or audits of Phase 1/2 clinical trials in China
·  Provide expertise on medical and clinical pharmacology questions from Health Authorities to support regulatory interactions, IRB/Ethics Committees, investigators, external experts

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.
·  Take an active part in the scientific challenges involved in early clinical development, which require a scientifically inquisitive, energetic, and proactive person.
·  Ensure 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.
·  Ensure high quality documents, requiring strong writing and communication skills.
·  Manage aggressive timelines effectively through cross-functional planning.

Key Internal/External Relationships:

·  Internal contacts: Pharmacokineticists, Clinical Trial Operations team (including clinical trial managers, data managers, feasibility managers), Clinical Study Team, Project Leader, Biostatistics, Preclinical Safety, Regulatory Affairs, Global Pharmacovigilance, Therapeutic Area Research and Development Groups, CSUs.
·  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, medical advice and input for any medical matter of the study/project, clinical pharmacology/translational medicine input for local development strategy, and information for regulatory authorities.

JOB-HOLDER ENTRY REQUIREMENTS:

Language skil ls:

·  Fluent in English (writing and speaking)

Education:

·  Advanced degree: M.D. or M.D./Ph.D., or PharmD or Ph.D degree in a health-related science
·  At least 2 years of experience in conducting clinical trials and clinical pharmacology
·  At least 2 years of experience in early drug development
·  At least 2 years of  experience with interactions with regulatory agencies for early drug development

Experience & knowledge:

·  Experience with the conduct of clinical trials 
·  Qualification in a medical specialization is preferred
·  Experience in clinical pharmacology and/or early development clinical trials is preferred
·  Experience in pharmacokinetics is preferred
·  Previous experience in Clinical Research and/or Drug Development and/or Pharmacovigilance
·  Previous experience in translational medicine is preferred
·  Knowledge in ICH, GCP, and local regulations

Core competencies:

·  Knowledge and mindset in early clinical development and translational research
·  Able to acquire and apply new technical skills
·  Scientifically inquisitive
·  Excellent communication skills
·  Committed and enthusiastic person with a positive, collaborative attitude

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.