Massachusetts Jobs

About the Job

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?

The Associate Clinical Research Director (Associate CRD) is noted as the clinical expert for the execution of dedicated studies of the programs. The role requires a well-organized, operationally focused, individual with good analytical skills and the ability deliver to multiple operational tasks.

The role of the Associate CRD is to:

• 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 Abbreviated Protocol and Protocol 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 medical reference in the Clinical Study team, ensuring the medical relevance of the clinical data

Key responsibilities include:

• Develop the abbreviated protocol

• Develop the final protocol and protocol amendments

• Medical support to clinical operation team during the clinical feasibility

• Review and provide clinical input across different study documents written subject information, CRF, e-diary, monitoring plan

• Medical 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

• Ensure continuous medical review of aggregated data during clinical trial conduct (DRSR, safety, stat outputs of blinded data, …) with operational support, bio stat and GSO

• Answer 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

• Collaborate and communicate appropriately with all function stakeholders to ensure optimal study execution in compliance with Good Clinical Practice (GCP), applicable laws and regulations as well as applicable standard operating procedures (SOPs), including but not limited to:

• Medical Writers to develop, review and finalize WSIs, study protocols and reports

• Clinical Scientists, Medical review team and Coding

• Pharmacovigilance (GSO, CME)

• CTOMs, Biostatisticians

• CSU medical advisors for the best knowledge of the study, compound, protocol

• TA Experts, senior CRDS, global clinical lead, GPHs and medical affairs

• CROs

• Regulatory affairs

• Collaborates with other CRDs within the project, ensures leadership, builds consensus, coordinates action plans with 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 the global project head and clinical lead

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

Experience

• Understanding of pharmaceutical product development and life cycle management gained through preferably 1 year of development and / or medical / clinical experience

• Good Scientific and medical expertise

• Good knowledge / expertise in clinical development and methodology of clinical studies

• Good communication skills (verbal and written) for interactions across functional areas and for interactions with key regulatory agencies

• Fluency in written and spoken English

• Ability to work within a matrix model

• Open to work in an international and intercultural environment

• Open-minded to apply and learn digital solutions

Minimum Level of any Required Qualifications:

• Medical Doctor (MD) preferred: GP or specialist, English fluent (spoken and written)

• At least 1 years in pharmaceutical industry or CRO, previous experience in clinical development

• Computer skills

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.

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.

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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.

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)