Clinical Research Director
Company: Sanofi
Location: Somerville
Posted on: January 15, 2021
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Job Description:
Clinical Research Director, Immuno-Inflammation (I&I)
DevelopmentThe 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 dermatology field
Understands and keeps updated with the pre-clinical, clinical
pharmacology and data relevant to the molecule of
interestCritically reads and evaluates relevant medical literature
with deep understanding of the data and status from competitive
productMaintains 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 planLeads the
development of the Abbreviated Protocol and Protocol
developmentProvides 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 drugEnsure 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 consultantsRegulatory responsibilities:Represents the Division
at key regulatory agency meetings as the medical spokesperson for
the studies and projectEnsures clinical data meets all necessary
regulatory standardsSupports 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 dataSupports the planning of advisory
board meetingsEstablishes and maintains appropriate collaborations
with knowledge expertsIn 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.Basic Qualifications:Medical Doctor with dermatology
clinical expertise or dermatologist (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 Qualifications:Strong scientific and academic background with
deep understanding of the diseaseClinical research or
pharmaceutical experience medicine experience in respiratory field
Knowledge of drug development and in immunologyGood networking
ability in cross-cultural environmentStrong interpersonal,
communication, presentation, and negotiation skills across all
levels of the organizationPerformance oriented with ability to work
along agreed timelines and a focus on strategy and executionFluent
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.GD-SALI-SAAt 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.Full time
Keywords: Sanofi, Somerville , Clinical Research Director, Healthcare , Somerville, Massachusetts
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