Clinical Research Director, I&I
Company: Sanofi
Location: Cambridge
Posted on: May 9, 2024
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Job 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
stakeholdersClinical 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 consultantsRegulatory 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 preparationScientific data dissemination - - - - - - -
Ensures timely submission and dissemination of clinical data - - -
- - - - Supports the planning of advisory board meetings - - - - -
- - Establishes and maintains appropriate collaborations with
knowledge expertsIn 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#GDAt 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.SummaryLocation: Cambridge,
MAType: Full time
Keywords: Sanofi, Malden , Clinical Research Director, I&I, Healthcare , Cambridge, Massachusetts
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