Senior Clinical Research Director

Job description

Job title : Senior Clinical Research Director Location: Cambridge, MA Clinical Research Director (Sr CRD) is 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 deliver to multiple operational tasks. The role of the Senior CRD is to: Act as a mentor for other CRDs and Clinical Scientists on within the project/Therapeutic Area (TA). Collaborate with functions to ensure uniform, aligned operational approach (e.g harmonizing study documents, ES, protocols, etc). As relevant, within a project, ensure leadership, build consensus, coordinate action plans with other CRDs and stakeholders to resolve project-related study issues, anticipates potential issues (sharing lessons learned) across the project or study teams. He/she raises study or project-level issues to TA Heads, as relevant and shares relevant information within and beyond Project teams. Take on as necessary the CRD role: Provide medical expertise to the clinical studies (except select Exploratory Pharmacology 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 authorities. Provide 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 investigators. Be the medical reference in the Clinical Study team, ensuring the medical relevance of the clinical data. Interact with other CRDs in the project, Global Project Head, Pharmacovigilance, Regulatory and other key functional reps. Join 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. About Sanofi We’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. Main responsibilities: Lead the clinical development plan strategies: Prepare documents and presentations for internal governance meetings. Responsible for the clinical development plans and clinical sections of integrated development plans (IDP). Collaborate with other CRDs within the project, providing leadership and building consensus. Coordinate action plans with stakeholders to resolve project-related study issues, anticipating potential issues (sharing lessons learned) across the project or study teams Raise study or project-level issues to the project head. Contribute to the definition of the product value proposition (TVP), 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 projects. Collaborate with external partners, regulators, and diverse internal stakeholders and collaborators. Evaluates relevant medical literature and status from competitive products. Lead, support and oversee the execution of clinical development and studies activities: Review and validate the clinical study report. Develop the abbreviated protocol. Review and validate the final protocol and protocol amendments. Review the ICF WSI and TDF. Co-Develop the SAP in collaboration with bio stats. Responsible for key results preparation. Develop the clinical study report. Assisted 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 feasibility. Review and provide clinical input across different study documents CRF, e-diary, monitoring plan. Ensure continuous medical review of aggregated data during clinical trial conduct (DRSR, safety, stat outputs of blinded data, …) with clinical scientist, bio stat and GSO. Lead the study specific committees (IDMC, steering com, adjudication …) with operational support. Answer to medical questions raised by EC/IRBs, sites. Responsibilities related to regulatory and safety documents and meetings: Represents his/her project at key regulatory agency meetings as the medical spokesperson for the studies and projects. Lead the strategy and structure of the clinical sections of the BLA/CTD, Briefing packages for regulatory meetings, PSP/PIP. Supports registrations, label submissions and modifications. Review and/or contribute in the the clinical section of the Investigator’s brochure, CTA, IND, DSUR, INDAR, DRMP, RMP. Contribute to the clinical sections of the BLA/CTD, Briefing packages for regulatory meetings, PSP/PIP. Ensures clinical data meets all necessary regulatory standards. Participates in Advisory Committee preparation. Scientific Data evaluation and authorship: Participate and author manuscripts and abstracts. Support the planning of advisory board meetings. Establish and maintains appropriate collaborations with knowledge experts. Contribute 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 teams. About You Minimum Level of Required Qualifications: Medical Doctor (MD) or equivalent At least 5 years experience in clinical development within the pharmaceutical industry or CRO Preferred Qualifications: ​ MD/PhD Specialty in Hematology Strong scientific and clinical acumen Expertise in clinical development, the methodology of clinical studies and life cycle management Excellent communication skills (verbal and written) for interactions across functional areas and for interactions with key regulatory agencies. Demonstrated capability to challenge decision and status quo with a risk-management approach Ability to negotiate to ensure operational resources are available for continued clinical conduct Fluency in written and spoken English Excellent teaching skills, demonstrated ability to assist and train others Ability to work within a matrix model. International/ intercultural working skills Open-minded to apply new digital solutions 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. Be part of a pioneering biopharma company that engages patients early in drug development and uses their insights to design studies that reflect real-world needs. Help improve the lives of millions of people globally by making drug development quicker and more effective. Work at the forefront of drug discovery, harnessing cutting-edge AI, data, and digital platforms to push the boundaries of science. 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 #vhd #LI-Hybrid 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. Sanofi US endeavours to make our career center accessible to any and all users. If you are experiencing difficulty and need assistance applying online, please call 1-866-SANOFI2 (1-866-726-6342) or click here US and Puerto Rico Residents Only Sanofi Inc. 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. North America Applicants Only The salary range for this position is: $236,250.00 - $393,750.00 All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.