Clinical Research Director (Somerville)

Job Title: Clinical Research DirectorLocation: Cambridge, MAAbout the JobJoin the engine of Sanofi’s mission — where deep immunoscience meets bold, AI-powered research. In R&D, you’ll drive breakthroughs that could turn the impossible into possible for millions.The Clinical Research Director (CRD) is a key clinical lead in the Development of R&D programs. The role requires a well-organized, strategically, operationally focused, resourceful individual with very good emotional intelligence, self-motivation, solid analytical skills, and the ability deliver to multiple operational tasks.About SanofiWe’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives.The role of the CRD is to:Collaborate with other medical and clinical scientific experts DMDs or Development Scientific Directors (DSDs) in the project under the leadership of the Global Project Head, with the Global safety Officer, Regulatory Strategist and other key functional representatives to deliver development strategy and prepare/assist with regulatory bodies interactionProvide clinical scientific expertise in the Study team to conduct the clinical studies from early phases to LCM programsDevelop the study level regulatory documentation (Abbreviated Protocol, Protocol, Amended protocol) for their project, lead other operational development activities pertaining to study start-up (e.g. pressure test, competitive intelligence, patient engagement, cluster feasibility, study risk assessment etc…)Provide appropriate clinical scientific input & support for all activities related to clinical studies conduct such as answers to IRBs and HA questions, protocol scientific and medical training, medical review of data within the scope of the Centralized monitoring, clinical and medical information for the study team, medical advisors/Clinical Project Leaders from Clinical Study Units, and investigators Contribute to the clinical part of Common Technical Document for submission to regulatory bodies (FDA, EMA, PMDA etc…) and answer to questions from health authorities. Be the scientific & medical reference in the Study team, ensuring the medical relevance of the clinical data Develop the study level regulatory documentation (Abbreviated Protocol, Protocol, Amended protocol) for their project, lead other operational development activities pertaining to study start-up (e.g. pressure test, competitive intelligence, patient engagement, cluster feasibility, study risk assessment etc…)Key responsibilities include: 1. Leading the clinical development plan strategies:Responsible for the clinical development plans and clinical sections of integrated development plans (IDP)Collaborate with other DMDs/DSDs within the project, ensures leadership, builds consensus, coordinates action plans with stakeholders to resolve project-related issues, anticipates potential issues (sharing lessons learned) across the project or study teamsRaise study or project-level issues to the project head and propose related corrective action plansContribute in the definition of the product value proposition (TVP), Target Product Profile (TPP) 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 projectCollaborates with external partners, regulators, scientific experts and internal stakeholdersRaise study or project-level issues to the project head and propose related corrective action plansEvaluates relevant medical literature and status from competitive products2. Lead, Support and oversee the execution of clinical development and studies activitiesCollaborate and communicate appropriately with all function stakeholders (e.g. clinical operations, project management, Patient Safety and Pharmacovigilance, regulatory, Finance, Scientific External Engagement, Procurement etc…), responsible for timelines, budgets and contingency/risk management plans to assure successful execution of the clinical trials in compliance with Good Clinical Practice (GCP), applicable laws and regulations as well as applicable standard operating procedures (SOPs)Develop the abbreviated protocol, the final protocol and protocol amendmentsDevelop/review the Core Study Informed Consent Form (CSICF)Develop/review Study committee ChartersCollaborate on key medical and clinical questions with the Global feasibility manager to prepare and interpret feasibility and competitive intelligence resultsReview and provide clinical input across different study documents Vendors RFPs, (e-)CRF,( e-)diary, (e- )CoA etcRaise study or project-level issues to the project head and propose related corrective action plansParticipate in the elaboration of training material and presentations at the investigator meetings/local teams trainingsAnswer to medical questions raised by HA, EC/IRBs, sitesEnsure quality of clinical data through continuous data validation, blinded Data review on summary tables or electronic data visualization during clinical trial conduct (AE dedicated review, and Clinical Case review for safety data and statistical surveillance for efficacy data,…)Raise study or project-level issues to the project head and propose related corrective action plansLead the study specific committees (IDMC, steering com, adjudication …) with operational supportCo-Develop the SAP in collaboration with bio statsResponsible for key results preparationRaise study or project-level issues to the project head and propose related corrective action plansResponsibilities related to regulatory and safety documents and meetings:Review and/or contribute in the clinical section of the Investigator’s brochure, CTA, IND, DSUR, , DRMP, RMPContribute in the clinical sections of the BLA/CTD, Briefing packages for regulatory meetings, PSP/PIPEnsures clinical data meets all necessary regulatory standardsCollaborates with the Patient Safety GSO to detect and document any safety signalParticipates in Advisory Committee preparationScientific Data evaluation and authorship:Participate and author manuscripts and abstractsEstablish and maintains appropriate collaborations with knowledge experts or advisory boardsContribute on an ad hoc basis to specific tasks such as the evaluation of potential in-licensing candidates for the therapeutic area and serves as the clinical advisor to research teamsExperience:Understanding of pharmaceutical product development and life cycle managementVery good Scientific and medical/clinical expertiseVery good expertise in clinical development and methodology of clinical studiesVery good communication skills (verbal and written) for interactions across functional areas and for interactions with key regulatory agenciesExcellent problem solving capabilityDemonstrated capability to challenge decision and status quo with a risk-management approachAbility to negotiate to ensure operational resources are available for continued clinical conductFluency in written and spoken EnglishVery good teaching skills, demonstrated ability to assist and train othersAbility to work within a matrix modelInternational/ intercultural working skillsOpen-minded to apply new digital solutions About YouMinimum Level of any Required Qualifications: Medical degree (MD) with specialization in dermatology or allergology or GP with experience in dermatology developmentMinimum 3 years in Clinical or Pharmaceutical industry experience (Atopic Dermatitis or Hidradenitis suppurative preferred)Previous experience in clinical developmentWhy 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 US Services and its U.S. affiliates are Equal Opportunity employers committed to a culturally inclusive 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-Hybrid#vhdPursue 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!US and Puerto Rico Residents OnlySanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants