Senior Clinical Scientist

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 throug