Contract Clinical Scientist - Remote

Boston, MA - Pharmaceutical & Biotech - Remote - Part time

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Date Posted: 12/5/2024

Contract Clinical Scientist
Boston, MA
Remote

Small biotech start up is seeking to develop therapies that transform the treatment of kidney disease for patients. The goal is to treat diseased kidneys using a patient’s own cells and prevent or delay dialysis or transplant.

They are seeking a highly motivated and experienced Clinical Scientist to join the clinical development team, focusing on the design, execution, and oversight of Phase 3 clinical trials. The Clinical Scientist will play a critical role in advancing our clinical programs, ensuring the generation of high-quality data, and contributing to the successful submission of regulatory dossiers.

Description:
Clinical Trial Design and Planning:
Collaborate with cross-functional teams, including Clinical Operations, Medical Affairs, Biostatistics, and Regulatory Affairs, to design scientifically rigorous Phase 3 trials. Contribute to the development of study protocols, investigator brochures, informed consent forms, and other essential study documents. Provide scientific input for trial endpoints, patient populations, and statistical analyses.

Study Execution and Oversight:
Act as the scientific lead for assigned Phase 3 studies, ensuring adherence to clinical trial protocols and regulatory requirements. Provide ongoing scientific and clinical input during trial execution, including participation in investigator meetings, site initiation visits, and study monitoring activities. Review and interpret clinical trial data, ensuring consistency and alignment with study objectives. Address protocol-related questions from investigators and site staff. Contribute to the preparation of regulatory submissions, including clinical study reports (CSRs) and documentation for Investigational New Drug (IND) and New Drug Application (NDA) filings. Ensure clinical trial activities are conducted in compliance with Good Clinical Practice (GCP) guidelines and applicable regulatory standards. Collaborate with the Biostatistics and Data Management teams to review and interpret study data, ensuring accuracy and completeness. Participate in the preparation of abstracts, presentations, and manuscripts for scientific meetings and publications. Partner with Medical Directors to develop and execute clinical development strategies. Serve as a subject matter expert within the clinical team, providing scientific insights to support decision-making.

Preferred Qualifications:
Experience in a specific therapeutic area (highly prefer renal/kidney, if not then oncology, cardiology, or rare diseases) relevant to the company’s pipeline. Familiarity with regulatory requirements for global clinical trials, including FDA and EMA guidelines. Proficiency in using clinical trial management systems and other relevant software.

Please contact Darren Gutowski at dgutowski@clarkdavis.com

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