Sanofi Group Clinical Research Director - I&I in Cambridge, Massachusetts
- The Clinical Research Director (CRD), Immunology and Inflammation Therapeutic Area, is responsible for contributing to the creation and execution of the clinical development strategy for Dupilumab in different indications. The CRD is expected to contribute to the growth of Dupilumab by both being a driver of clinical and scientific knowledge and advancing operational capabilities by challenging “the status quo”.
Principal Duties & Responsibilities:
Based upon an in-depth scientific understanding and extensive clinical experience, the CRD is responsible for:
Drafting the abbreviated protocol of studies that he/she will be responsible for, and lead the creation of the clinical development plans (CDP), the clinical sections of integrated development plans (IDP), as well as overseeing the execution of such plans by the respective operational units in compliance with Good Clinical Practice (GCP), applicable laws and regulations as well as applicable standard operating procedures (SOPs). He/she will also represent the project in relevant teams and the protocol review committee and review and comment the Investigator’s brochure.
Lead and write clinical sections of the BLA/CTD, Briefing packages for regulatory meetings, PSP/PIP
Assisted by related Sanofi Genzyme functions (e.g. clinical operations, project management, and procurement), responsible for defining timelines, budgets and contingency/risk management plans to assure successful execution of the clinical trials.
Defends the CDP in front of internal management committees, regulatory agencies, and alliance partners, where applicable. The CRD may provide input into strategies to increase understanding of the mechanism of action of the drug including but not limited to the identification of biomarkers. On an ad hoc basis the CRD will be requested to contribute expertise to specific tasks such as the evaluation of potential in-licensing candidates for I&I therapeutic area and serves as the clinical advisor to research teams.
Scientific and Technical Expertise:
This position requires a strong scientific and clinical foundation in dermatology or respiratory or allergy as well as in all aspects of drug development. Advanced leadership skills and the ability to effectively collaborate with external partners, regulators, and diverse internal stakeholders and collaborators are essential prerequisites.
Has and maintains deep scientific, technical and clinical expertise in dermatology or respiratory or allergy and related areas
Understands and keeps updated with the pre-clinical, clinical pharmacology and data relevant to the molecule of interest
Critically reads and evaluates relevant medical literature with deep understanding of the data and status from competitive products
Maintains visibility within the Immunology & Inflammation Therapeutic Area in general and more specifically in dermatology or respiratory or allergy to maintain credibility with internal and external stakeholders
Ensure that all development activities are proactively planned and targeted towards timely achievement
Interacts with opinion leaders and consultants.
Owns (in collaboration with Project Team), the “Abbreviated protocol” for individual studies, the clinical sections of BLA, CDP and the clinical sections of the IDP and is responsible Clinician for the implementation of clinical strategy
Influences the definition of the product value proposition and market access strategy (in collaboration with respective functions)and the focus of the research strategy, by providing input on existing clinical needs and approaches to clinical development strategies for research projects
Complex problem solving
As CDPs, BLAs/CTDs are sophisticated documents that require the ability to integrate highly complex scientific, medical and operational information, strong scientific, medical and analytical skills are required.
An innovative and open-minded approach to problem solving is critical to arrive at the optimal solution for complex development challenges.
Represents his/her project at key regulatory agency meetings as the medical spokesperson for the studies and project
Responsible for BLA clinical sections
Ensures clinical data meets all necessary regulatory standards
Supports registrations, label submissions and modifications
Participates in Advisory Committee preparation
Scientific Data Dissemination:
Ensures timely submission and dissemination of clinical data
Participate and author manuscripts and abstracts
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 his/her contributions to the Global Project Team are conducted in compliance with current regulations, laws and guidance from FDA, EMA, and CHMP, as well as with Sanofi’s policies and procedures.
Medical Doctor, PhD desirable. Should be board certified or eligible in dermatology, or respiratory, or allergy or Immunology or
Must have completed education and training at a medical school
More than 5 years of clinical or scientific, or more than >10 years industry, experience within I&I or dermatology or respiratory (pulmonology, rhinology, ENT) drug development
Strong scientific and academic background with deep understanding of the disease
Clinical research experience in dermatology, allergology, respiratory drug development preferred
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
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.
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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