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

    Sanofi Group
    Sanofi Group Cambridge, United States

    3 weeks ago

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    Description

    CLINICAL RESEARCH DIRECTOR, I&I


    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/allergy/immunology clinical expertise preferred
    • Pediatric experience preferred
    • Translational research experience preferred, especially analyzing multiomic outputs to identify gene/protein dysregulation and its application to dermatology, respiratory, rheumatologic and gastrointestinal diseases
    • 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 in 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)

    Pursue
    _progress_
    , discover
    _extraordinary_
    Better is out there. Better medications, better outcomes, better science.

    But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen.

    So, let's be those people.


    At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

    Watch our ALL IN video ) and check out our Diversity Equity and Inclusion actions at )
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