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    Clinical Research Director, I&I - Cambridge, United States - Sanofi Group

    Sanofi Group
    Sanofi Group Cambridge, United States

    7 hours ago

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    Description

    The Clinical Research Director (CRD), Amlitelimab, Immunology and Inflammation Therapeutic Area 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.


    The role requires a self-starting, creative, well-organized, strategic focused, resourceful individual with excellent emotional intelligence, self-motivation, solid analytical skills and the ability to deliver on multiple operational tasks.

    They must be able to comfortably operate independently and within a matrix team, both face to face and remotely.

    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/immunology field
    • Has a demonstrated track record in clinical development, with Phase 3 experience being an advantage
    • Understands and keeps updated with the pre-clinical, clinical pharmacology and data relevant to the molecule of interest - Knowledge on antibody 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
    • Represents the clinical function on Clinical Study Teams and other teams as appropriate.
    • 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. Abbreviated 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 external consultants

    Regulatory responsibilities

    • Represents the Division at key regulatory agency meetings as the medical spokesperson for the studies and project
    • Ensures clinical data meets all necessary regulatory standards
    • 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 data
    • 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 Global Project Team (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.


    Basic Qualifications

    • Medical Doctor with dermatology, respiratory or GI experience a plus
    • 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
    • Knowledge of drug development and immunology
    • Good networking ability in cross-cultural environment
    • 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.

    \#LI

    \#GD

    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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