Senior Clinical Research Director, I&I

Sanofi·
Cambridge, MA
1mo ago
Full-timeSeniorVaccines
$236K - $394K/yr(estimated)

Description

<p><b>Job Title: </b>Senior Clinical Research Director</p><div><p><b>Location: </b>Cambridge, MA, Morristown, NJ</p></div><p></p><p></p><p><b>About the Job</b></p><p></p><p>Join the engine of Sanofi’s mission — where deep immunoscience meets bold, AI-powered research. In R&amp;D, you’ll drive breakthroughs that could turn the impossible into possible for millions.</p><p></p><p><b>About Sanofi:</b><br />We’re an R&amp;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.</p><p></p><p><b>Main Responsibilities:</b><br /> </p><p>The role of the Senior CRD is to:</p><ul><li><p>Act as a mentor for other CRDs and Clinical Scientists on a same project/TA</p></li><li><p>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.</p></li><li><p>Take on as necessary the CRD role:</p><ul><li><p>Provide medical expertise to the clinical studies (except select Exploratory Pharmacology studies) and/or registries (eg: protocol, Key Results, Clinical Study Report)</p></li><li><p>Support other clinical development activities (e.g. pressure test and cluster feasibility, medical review and validation of clinical data, study risk assessment)</p></li><li><p>Contribute to the clinical part of submission dossier for their projects: Common Technical Document for FDA &amp; EMA submission, filing in Japan and China and<span> </span>answers to questions from health authorities</p></li><li><p>Provide appropriate medical input &amp; 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</p></li><li><p>Be the medical reference in the Clinical Study team, ensuring the medical relevance of the clinical data</p></li><li><p>Interact with other CRDs in the project, Global Project Head, The PV Rep, Regulatory and other key functional reps</p></li></ul></li></ul><p></p><p><b>About You</b></p><p><b>Experience</b></p><ul><li><p>Understanding of pharmaceutical product development and life cycle management gained through ~4 years of clinical development and medical experience</p></li><li><p>Excellent Scientific and medical / clinical expertise</p></li><li><p>Excellent expertise in clinical development and methodology of clinical studies</p></li><li><p>Excellent communication skills (verbal and written) for interactions across functional areas and for interactions with key regulatory agencies</p></li><li><p>Demonstrated capability to challenge decision and status quo with a risk-management approach</p></li><li><p>Ability to negotiate to ensure operational resources are available for continued clinical conduct</p></li><li><p>Fluency in written and spoken English</p></li><li><p>Excellent Teaching skills, demonstrated ability to assist and train others</p></li><li><p>Ability to work within a matrix model</p></li><li><p>International/ intercultural working skills</p></li><li><p>Open-minded to apply new digital solutions</p></li></ul><p></p><p><b>Minimum Level of any Required Qualifications: </b></p><ul><li><p>MD or eqivalent (DO, MBBS)</p></li><li><p>Specialization and training as a Rheumotologist</p></li><li><p>At least 4 years in pharmaceutical industry or CRO, previous experience in late stage clinical development</p></li><li><p>English fluent (spoken and written)</p></li></ul><p></p><p><b>Why Choose Us?</b> </p><ul><li><p>Bring the miracles of science to life alongside a supportive, future-focused team. </p></li><li><p>Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or a lateral move, at home or internationally. </p></li><li><p>Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. </p></li><li><p>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. </p></li></ul><p></p><p>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.</p><p></p><p>#GD-SA<br />#LI-SA<br />#LI-Onsite<br />#vhd</p><p style="text-align:inherit"></p><p style="text-align:inherit"></p><h1>Pursue <i>progress</i>, discover <i>extraordinary</i></h1><p>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.</p><p></p><p>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.</p><p></p><p>Watch our <a href="https://www.youtube.com/watch?v&#61;SkpDBZ-CJKw&amp;t&#61;67s" target="_blank">ALL IN video</a> and check out our Diversity Equity and Inclusion actions at <a href="https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness" target="_blank">sanofi.com</a>!</p><p></p><p></p><p><i>US and Puerto Rico Residents Only</i></p><p>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.</p><p></p><p><i>North America Applicants Only</i></p><p></p><p>The salary range for this position is:</p>$236,250.00 - $393,750.00<p></p><p>All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the <a target="_blank" href="https://benefits.sanofiusallwell.com/fleet/public/index/ba511bf8-5c32-4828-9861-ab985fffab90/?cid&#61;sanofi">LINK</a>.</p>
Sanofi

Sanofi

PHARMACEUTICAL

Small Molecules, Biologics

LocationPARIS, France
Employees91,000
Open Jobs1140
ImmunologyOncologyNeurologyRare DiseasesVaccines
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Pipeline

Efluelda® Pre-filled syringeN/A
Investigational ProceduresN/A
swab samplingN/A
InsulinN/A
Kidney Information Network for Disease Research and EducationN/A