Clinical Research Director
Cambridge, Massachusetts, Bridgewater, New Jersey
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The Clinical Research Director (CRD), I&I Therapeutic Area is responsible for contributing in the creation and execution of the clinical development strategy for projects in the area of immune driven diseases for SAR441344 aCD40L mAb program. The CRD is expected to contribute to the growth of the I&I TA by proactively contributing scientific knowledge and advancing operational capabilities in the field of autoimmune diseases.
Principal Duties & Responsibilities
Based upon an in-depth understanding of the science, the strategic potential of the compound and the clinical domain for development, the CRD is responsible for:
Drafting the extended synopsis of studies that he/she will be responsible for, and contribute to the clinical development plans (CDP), review of Investigator’s brochure, the clinical sections of integrated development plans (IDP), and overseeing the execution of such plans by the respective operational units in compliance with SOP, GCP and other regulations.
Assisted by related Sanofi 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.
Scientific and Technical Expertise
This position requires a strong scientific and clinical foundation in in autoimmune conditions as well as in all aspect of pharmaceutical 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 internal medicine and/or relevant therapeutic areas (rheumatology, nephrology, gastroenterology…), as well as in immunology and translational medicine.
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 I&I therapeutic area to maintain credibility with internal and external stakeholders in R&D and in the specialty care BU
Ensure that all development activities are targeted towards timely achievement
Interacts with opinion leaders and consultants.
Owns (in collaboration with Project Team), the “Extended synopses” for individual studies CDP and clinical sections of IDP and is responsible Clinician for the implementation of clinical strategy
Influences the definition of the product value proposition (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 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 the I&I TA 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
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 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 or Doctor of internal medicine and experience auto immune diseases and the field of internal medicine and/or relevant therapeutic areas (rheumatology, nephrology, gastroenterology…) Must have completed education and training at a medical school that meets the requirements of the Liaison Committee on Medical Education (LCME)
Strong scientific and academic background with deep understanding of the disease
Knowledge of 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.