Clinical Research Director, I&I
Company: Sanofi
Location: Cambridge
Posted on: May 8, 2024
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Job Description:
The Clinical Research Director (CRD), Immunology & Inflammation
(I&I) Therapeutic Area is responsible for the creation of the
clinical development plan in alignment with the project strategy,
its endorsement by governance and its execution in close
collaboration with clinical operations. -The CRD is expected to
advance scientific and clinical knowledge for immunology in
rheumatological or osteoarthritic diseases, incorporate new
methodologies, and pro-actively progress study execution. - - -MAIN
RESPONSIBILITIES - - - - - - - - - Create the clinical development
strategy for one or more assets and document it in the clinical
development plan in collaboration with the global project team and
internal partners such as clinical operations, translational
medicine, regulatory affairs, biostatistics, drug discovery, drug
safety, marketing - - - - - - - - - Advance the CDP through
internal management review - - - - - - - - - Leads a clinical sub
team to design clinical studies and to create an abbreviated and
full clinical study protocol - - - - - - - - - Oversee the
execution of clinical studies in compliance with internal SOPs,
GCP, ICH guidelines and other regulations - - - - - - - - - Review
documents supporting clinical development such as Investigator's
brochure, regulatory documents for IND / CTA, clinical sections of
integrated development plans, and submission dossiers for
regulatory approval - - - - - - - - - Support drug registrations
(contribution to submission dossiers label draft, regulatory
response during the review process, Advisory Committee preparation)
- - - - - - - - - Contribute to data review, interpretation and
publication of clinical study results - - - - - - - - - Represent
Clinical Development at Health Authorities and incorporating advise
into development strategy. - - - - - - - - - Maintain or establish
interaction with external scientific and clinical communities and
to incorporate pertinent advice and learnings into the internal
program - - - - - - - - - Align company position on clinical
strategy with partner in alliance projects - - - - - - - - -
Translate biology into clinic in close collaboration with research
and translational medicine - - - - - - - - - Evaluate clinical
aspects of business development opportunities as needed - - - - - -
- - - Apply high ethical standards and work with
integrity---PROFILEScientific and Technical ExpertiseThis position
requires a strong scientific and clinical foundation rheumatology
or osteoarthritis. - Advanced leadership skills and the ability to
effectively collaborate with external partners, regulators, and
diverse internal stakeholders and collaborators are essential
prerequisites. - - - - - - - - - Be experienced in advancing assets
from discovery into clinical development - - - - - - - - - Have
experience in novel approaches in translational medicine - - - - -
- - - - Have and maintain deep scientific, technical and clinical
knowledge in arthritic diseases - - - - - - - - - Demonstrated
problem solving skills - - - - - - - - - Understand and keep
updated with the pre-clinical, clinical pharmacology and clinical
data relevant to the molecule of interest and the respective
therapeutic area - - - - - - - - - Be able to translate current
understanding of disease pathogenesis into functional consequences
and clinical outcome - - - - - - - - - Understand novel biomarker
and precision medicine approaches, novel clinical trial designs,
endpoints and statistical methods - - - - - - - - - Understand the
competitive environment - - - - - - - - - Have established
connections within the medical field of their expertise - - - - - -
- - - Have a credible publication recordBasic Qualifications - - -
- - - - - - Medical Doctor. Should be board certified or equivalent
in dermatology or allergy / immunology - - - - - - - - - Must have
completed education and training at a medical school that meets the
requirements of the Liaison Committee on Medical Education (LCME)
or equivalent - - - - - - - - - More than 5 years of clinical or
scientific and/or more than > 10 years industry experience
within the field of dermatology - - - - - - - - - Strong scientific
and academic background within clinical research, pharmaceutical
experience or experimental medicine experience in the respective
therapeutic area preferred - - - - - - - - - Knowledge of drug
development preferred - - - - - - - - - Strong interpersonal,
communication, presentation, negotiation and networking skills in a
cross-cultural global environment - - - - - - - - - Performance
oriented with ability to work along agreed timelines and a focus on
strategy and execution - - - - - - - - - Outstanding communicator.
Excellent problem-solving, conflict-resolution and decision-making
skills - - - - - - - - - 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.#GD-SA - -#LI-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.SummaryLocation: Cambridge, MA; Bridgewater,
NJType: Full time
Keywords: Sanofi, Malden , Clinical Research Director, I&I, Executive , Cambridge, Massachusetts
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