Senior Clinical Research Director, Immunology & Inflammation

JOB DESCRIPTIONSenior Clinical Research DirectorThe Senior Clinical Research Director (Sr CRD) is noted as the primary clinical lead for programs.The role requires a well-organized, strategic focused, resourceful individual with excellent emotional intelligence, self-motivation, solid analytical skills and the ability to deliver on multiple operational tasks.The role of the Senior CRD is to:Lead the development of the program clinical strategy (including Life Cycle strategy), integrating the commercial strategy and the Therapeutic Area (TA) general orientationOversee all the medical documentation generated throughout the program life (protocols, clinical study reports, clinical sections of IB, briefing books)The senior CRD:Reports to the Global Project Head (GPH)Manages the other CRDs on the same programLeads the global clinical teamWorks with the alliance counterpart to reach alignment on the clinical strategyCollaborates with functions to ensure full strategic and operational alignmentAs direct manager of the program CRDs, the senior CRD may occasionally have to deliver on the CRD role:Provide medical expertise to the clinical studies and/or registries (eg: protocol, Key Results, Clinical Study Report)Support other clinical development activities (e.g. pressure test and cluster feasibility, medical review and validation of clinical data, study risk assessment)Contribute to the clinical part of submission dossier for their projects: Common Technical Document for FDA & EMA submission, filing in Japan and China and answers to questions from health authoritiesProvide appropriate medical input & support for all activities related to clinical studies such as medical training, feasibility, medical review of data, medical information for the study team, medical advisors/Clinical Project Leaders from Clinical Study Units, and investigatorsBe the medical reference in the Clinical Study team, ensuring the medical relevance of the clinical dataKey responsibilities include: Lead the clinical development plan strategy:Establish Target Product Profile (TPP) and Target Value Proposition (TVP) and contribute to the commercial and market access strategy (in collaboration with respective functions), by providing input on existing clinical needs and approaches to clinical development strategiesResponsible for the clinical development plans and clinical sections of integrated development plans (IDP)Preparation of documents and presentations for internal and alliance governance meetingsManage other CRDs within the project, ensure leadership, build consensus, coordinate action plans with stakeholders to resolve project-related study issues, anticipate potential issues (sharing lessons learned) across the project and study teamsRaise study or project-level issues to the Global Project HeadCollaborate with external partners, regulators, and diverse internal stakeholders and collaboratorsEvaluate relevant medical literature and status from competitive productsLead, Support and oversee the execution of clinical development and studies activitiesReview and validate the Abbreviated Protocol (AP), clinical study protocol, Statistical Analysis Plan (SAP), Key result Memo (KRM) and Clinical Study Report (CSR)Oversee the program CRDs in the following activities (may occasionally need to take on the CRD role)Develop the abbreviated protocolDevelop the final protocol and protocol amendmentsReview the ICF WSI and TDFCo-Develop the SAP in collaboration with biostats teamPrepare key results memoDevelop the clinical study reportAssisted by related functions (e.g. clinical operations, project management, and procurement), 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)Medical support to clinical operation team during the clinical feasibilityReview and provide clinical input across different study documents CRF, e-diary, monitoring planEnsure continuous medical review of aggregated data during clinical trial conduct (DSR, safety, stat outputs of blinded data, ) with clinical scientist, bio stat and Global Safety OfficerLead the study specific committees (IDMC, steering com, adjudication ) with operational supportAnswer to medical questions raised by EC/IRBs, sitesResponsibilities related to regulatory and safety activities: Represent the program at key regulatory agency meetings as the medical spokesperson Lead the strategy and structure of the clinical sections of the BLA/CTD, briefing packages for regulatory meetings, PSP/PIP Support registrations, label submissions and modifications Participates in Advisory Committee preparation Review and validate the clinical sections of the Investigator’s Brochure (IB), CTA, IND, DSUR, DRMP Oversee the program CRDs for the following activities:Write the clinical sections of the IB, CTA, IND, DSUR, DRMPWrite the clinical sections of the BLA/CTD, briefing packages for regulatory meetings, PSP/PIPEnsure clinical data meets all necessary regulatory standardsScientific Data evaluation and authorship: Participate and author manuscripts and abstractsSupport the organization of advisory board meetingsEstablish and maintain appropriate collaborations with knowledge expertsContribute on an ad hoc basis 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 teamsExperienceUnderstanding of pharmaceutical product development and life cycle management gained through at least 4 years of clinical development and medical experienceExperience in late-stage clinical development program and regulatory submissionExcellent scientific and medical/clinical expertiseExcellent expertise in clinical development and methodology of clinical studiesExcellent communication skills (verbal and written) for interactions across functional areas and for interactions with key regulatory agenciesDemonstrated 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 EnglishExcellent teaching skills, demonstrated ability to assist and train othersAbility to work within a matrix modelInternational/ intercultural working skillsOpen-minded to apply new digital solutionsMinimum Level of any Required Qualifications:Medical Doctor (MD) preferred: specialist, English fluent (spoken and written), certification in pulmonary medicine is a plusAt least 4 years in pharmaceutical industry or CRO, previous experience in clinical developmentAt 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.PDN-94f8fc4d-c49b-4252-b3af-ec6a835893c5