Clinical Research Director, I&I

About the JobWe 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 role requires a highly motivated, agile, strategic individual with solid analytical skills, excellent verbal and written communication skills and the ability to deliver on multiple tasks. Additionally, the individual must be able to work both independently and collaboratively in a fast-paced team/ matrixed environment.Some core responsibilities of the CRD include the following, as well as all other potential assigned duties.Scientific and technical expertiseHas and maintains deep scientific, technical and clinical expertise in respiratory/immunology fieldHas a demonstrated track record in clinical development, preferably in industry, with Phase 3 experience being an advantageUnderstands and keeps updated with the pre-clinical, clinical pharmacology and data relevant to the molecule of interest – development experience with large molecules is advantageousMaintains current knowledge of industry advancements and competitive landscape in therapeutic areas through conferences, literature, and training.Clinical research planning and executionContributes to the development of the clinical strategy and planLeads the development of the Abbreviated and Final ProtocolPerforms medical oversight of clinical trials, drafts protocols and informed consent documents, and addresses queries from regulatory bodies, IRBs, and ethics committees. Reviews clinical data and ensures accuracy for final clinical study reports.Monitors safety with the general safety officer throughout trials, ensures adherence to company standards and regulatory requirements (GCP/ICH), and supports development of investigator brochures.Leads the design, analysis, interpretation, and reporting of scientific content for protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions, and study-related documents.Advanced leadership skills and the ability to effectively collaborate with external partners, regulators, and diverse internal stakeholders and collaborators are essential prerequisites.Leads the clinical function on Clinical Study Teams and represents the clinical function on other teams as appropriate.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.About youBasic QualificationsMedical Doctor with allergy or respiratory experience a plusProven 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 plusStrong scientific and academic background with deep understanding of the diseaseKnowledge of drug development and immunologyStrong 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 executionWhy 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.#GD-SA  #LI-SA#LI-Onsite#vhd​Pursue progress, discover extraordinaryBetter 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!SummaryLocation: Cambridge, MAType: Full time