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**Job title** : Senior Clinical Scientist

**Location:** Cambridge, MA

About the Job

Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress.

Reporting to the Clinical Lead, the Senior Clinical Scientist is noted as the scientific expert for the execution of dedicated studies of assigned program. The role requires a well-organized, operationally focused, individual with good analytical skills and the ability deliver multiple operational tasks.

The role of the Senior Clinical Scientist is to:

+ Provide scientific 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 Abbreviated Protocol, the final protocol and protocol amendments and the clinical study report for their project

+ 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 clinical reference in the Clinical Study team related to clinical data

Main Responsibilities:

+ Ensure continuous medical review of aggregated data during clinical trial conduct (DRSR, safety, stat outputs of blinded data, listing, patient profile, etc) with operational support, bio statistics and global safety officer

+ Support the development of the abbreviated protocol

+ Support the development of the final protocol and protocol amendments

+ Author medical related study documents (pre-defined deviation list, the Informed Consent Form, Written Subject Information, study specific committee charter, etc)

+ Clinical support to clinical operation team during the clinical feasibility

+ Review and provide clinical input across different study documents (CRF, patient diary, central monitoring plan, QTL, deviation review, etc)

+ Clinical support to clinical operations team on study plans: CMP/MRP, DR & DS review

+ Review/approve study-related documents (eg vendor specifications for centralized services, CRF, CRF completion guidance, patient diary, etc)

+ Participate in the elaboration of training material and presentations at the investigator meetings

+ Assist in the processing of responses to medical questions raised by EC/IRBs, sites

+ Support CRD trial master file documents readiness and availability, and mandatory trainings linked to the clinical function

• Provide operational expertise to project clinical sub team, as needed

About You

Job requirements

+ PhD in any biomedical discipline, post-doctoral studies in hematology / oncology is preferred; Pharm D with significant clinical data experience can apply

+ Must have at least 2+ years of experience in clinical development within pharmaceutical industry or CRO

+ Computer and MS application skills

+ Fluency in written and spoken English

+ Ability to work and interact within a matrix model

+ Open to work in an international and intercultural environment

+ Open-minded to apply and learn digital solutions

Why Choose Us?

We 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?

+ 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** **_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.

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 (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t=67s) and check out our Diversity Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) !

_US and Puerto Rico Residents Only_

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.

_North America Applicants Only_

The salary range for this position is:

$147,000.00 - $212,333.33

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 LINK (https://benefits.sanofiusallwell.com/fleet/public/index/ba511bf8-5c32-4828-9861-ab985fffab90/?cid=sanofi) .

Global Terms & Conditions and Data Privacy Statement (https://www.sanofi.com/en/careers/global-terms-and-conditions/)

Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting www.sanofi.com or via our movie We are Sanofi (https://youtu.be/96EwNjb1TLo)

As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live.

All in for Diversity, Equity and Inclusion at Sanofi - YouTube (http://www.youtube.com/watch?v=SkpDBZ-CJKw&t=2s)