We are seeking a Clinical Scientist to in implementing clinical trials in Immuno-oncology with high quality in compliance with the ICH/GCP, Regulatory Authorities' regulations/guidelines, and Myeloid SOPs. The Clinical Scientist serves as part of the team within the Clinical Development division and works closely with the both the Medical and the Clinical leads.

 

Responsibilities

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• Major areas of responsibility will include study oversight, clinical data review and analysis, cultivation of investigator and advisor relationships, internal and external representation of clinical development on study program teams and provision of scientific and clinical guidance to study designs, including translational medicine clinical implementation, regulatory correspondence and overall program strategy.

• Contribute to the oversight of study conduct in collaboration with clinical operations.

• Contribute to translational medicine plan and in collaboration with the translational medicine team operationalize correlative studies

• Collaborate with internal and external stakeholders (clinical operations, translational medicine, data management, biostatistics, safety and regulatory groups) to ensure translation of the clinical protocol into operational deliverables.

• Conduct clinical data review and initiate independent analysis

• Perform ongoing review of clinical trial data (safety and efficacy including assessing for consistency and completeness and providing preliminary assessments and recommendations).

• Participate in ongoing and cross-functional clinical review of study data and study close-out activities such as securing data and clinical study report generation.

• Review and contribute to authoring of study protocols and other study related documents such as investigator brochure, informed consent forms, case report forms, and others as needed

• Support safety monitoring by tracking, analyzing and reporting any potential safety events, by assisting/conducting clinical review of safety narrative and other safety-related guidelines and documents and participating in internal safety meetings

• Contribute to the authoring and revision of regulatory submissions and assist program team in responding to clinical inquiries from health authorities

• Review and synthesize scientific literature and competitive intelligence to support study and program strategy

• Develop scientific and clinical presentations to support internal and external meetings and present at such meetings as needed including site qualification and initiation visits, study investigator meetings and program/corporate governance meetings

• May contribute to writing or review of abstracts and poster for scientific meeting.

 

Qualification & Education

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• Advanced scientific or clinical degree in health science field ( PhD, PharmD, MPH)

• 3+ years of relevant clinical development experience

• Background in immunology, with experience in immune-oncology a plus

• Extensive knowledge of the drug development process, FDA and EMEA regulations and ICH GCP guidelines

• Excellent organizational, oral, written and interpersonal skills

• Proficiency in MS Word, Excel, PowerPoint

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Working Conditions

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• English is the predominant language for most regulatory documents handled by this position; must be able to demonstrate good verbal and written English.

• Domestic and/or international travel as needed, ~20%

• Location: On Site, Cambridge, MA

• Non-employee contract

• Full-Time, Exempt