Location: Bridgewater,NJ, USA
About the Job
We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people's lives. We're also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?
The Clinical Research Director (CRD), Dupilumab, 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.
As this role is on a large, complex, and highly successful team, the position 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
Some of the CRD's core job responsibilities include those listed below, as well as all other duties assigned.
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 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 I&I field to maintain credibility with internal and external stakeholders
* 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
Clinical research planning and execution
* An innovative and open-minded approach to problem solving is critical to arrive at the optimal solution for complex development challenges.
* 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.
* 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 consultants
Regulatory 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 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 (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 is preferred. with dermatology/allergy/immunology/pulmonary clinical expertise preferred
* More than 5 years of clinical or scientific experience, or more than >10 years industry, experience within I&I drug development
* 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
* 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)
Why Choose Us?
* Bring the miracles of science to life alongside a supportive, future-focused team.
* Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally.
* Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
* Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave.
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.
Pursue progress, discover extraordinary
Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.
Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!
US and Puerto Rico Residents Only
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; 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.