Clinical Research Director - I&I
Cambridge, Massachusetts, Chilly-Mazarin, France
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The I&I Clinical Research Director (CRD) is responsible for the development, execution and reporting of clinical trials in support of the registration of a product, directly reporting to the Clinical Lead in charge of the clinical strategy. In addition, the CRD is responsible for the development of abbreviated protocol and clinical protocol, participates to the review process for protocols, study reports, labeling, and contributes/supports interactions with regulatory agencies and ethics committees. -Some of the CRD’s core job responsibilities include those listed below, as well as all other duties assigned.
Scientific and Technical Expertise:
Has and maintains deep scientific, technical and clinical expertise in respiratory field (in particular for COPD indication)
Understands and keeps updated with the pre-clinical, clinical pharmacology and data relevant to the molecule of interest – Knowledge on biologic development is a plus
Critically reads and evaluates relevant medical literature with deep understanding of the data and status from competitive products
Maintains visibility within the respiratory field to maintain credibility with internal and external stakeholders
Clinical research planning and execution:
Contributes to the development of the clinical strategy and plan
Leads the development of the Abbreviated Protocol and Protocol development
Provides input into the Translational Medicine Plan that defines the biomarker strategy and other aspects to increase the knowledge about the pathway and effects of the drug
Ensure that all development activities are targeted towards timely achievement (e.g. Abreviated Protocol and protocol before study start, committees management and centralized monitoring during study, and KRM & CSR preparation at study end)
Interacts with opinion leaders and consultants
Represents the Division at key regulatory agency meetings as the medical spokesperson for the studies and project
Ensures clinical data meets all necessary regulatory standard
Supports registrations, label submissions and modifications (contributes to IB, DSUR, Briefing Package for Health Authorities…)
Participates in Advisory Committee preparation
Scientific data dissemination:
Ensures timely submission and dissemination of clinical dat
Supports the planning of advisory board meetings
Establishes and maintains appropriate collaborations with knowledge experts
In addition to the above activities, the CRD must ensure that all activities of the GPT are conducted in compliance with current regulations, laws and guidance from FDA, EMEA, and CHMP, as well as with Sanofi’s policies and procedures.
Medical Doctor with respiratory medicine clinical expertise or Pulmonologist (preferred)
At least 2 years’ experience in pharmaceutical drug development or clinical research
Proven record of scientific achievement as evidenced by presentations and publications in peer-reviewed journals and/or successful completion of major clinical studies or submissions is a plus
Strong scientific and academic background with deep understanding of the disease
Clinical research or pharmaceutical experience medicine experience in respiratory field
Knowledge of drug development and in immunology
Good networking ability in cross-cultural environmen
Strong interpersonal, communication, presentation, and negotiation skills across all levels of the organization
Performance oriented with ability to work along agreed timelines and a focus on strategy and execution
Fluent in English (verbal and written communication)
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.
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.
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