Senior Scientist, Clinical Research

e.g., knowledge of clinical trial management and trial execution; clinical site training/monitoring; medical and regulatory writing

Adaptability, Adaptability, Biopharmaceutical Industry, Clinical Development, Clinical Research, Clinical Study Management, Clinical Trial Planning, Clinical Trials, Clinical Trials Analysis, Drug Development, Ethical Compliance, Ethical Standards, ICH GCP Guidelines, Immunology, Medical Writing, Multiple Therapeutic Areas, Phase I Studies, Project Management, Protocol Development, Regulatory Requirements, Regulatory Submissions, Regulatory Writing, Risk Assessments, Scientific Publications, Technical Writing {+ 1 more}

Global Phase I subject and patient trials, safety reporting, and regulatory WMA submission experience a plus.

The Early Clinical Scientist (ECS) coordinates the design, planning and execution of early phase clinical trials with the Clinical Director, and internal/external team members.  Oversees trials within and/or across program(s)/therapeutic areas and ensures excellence in execution/compliance to support study objectives and data validity.

Manages internal/external team performance to achieve project objectives and resolves project performance issues if they arise.

Ensures appropriate clinical safety assessment and risk management of compounds.

Conducts real-time oversight of ongoing trials to identify and mitigate patient, study design, data or study conduct issues.  Reviews and interprets clinical trial data. May conduct on-site study monitoring, including site training & supervision of complex, novel endpoint/biomarker collection processes.  Applies thorough knowledge of GCP, ICH guidelines and regulatory requirements for clinical development.

Represents Early Stage Development on cross-functional teams to develop and/or improve internal job aids/SOP/clinical development procedures.  Identifies and communicates best practices within the organization.  Promotes departmental adaptation of new procedures.

Co-authors clinical sections of protocols, clinical investigator brochures, clinical study reports, Worldwide Marketing Application/Common Technical Document (WMA/CTD) subsections, and regulatory agency update and safety reports, as well as clinical development plans, publications, and abstracts.