Overview

Reference Number: JO-1910-440183
Clinical Scientist
Rate: Negotiable
Job Type: Permanent
Location: United States

A Clinical Scientist is required at a fast growing oncology biotech in Menlo Park, CA
The company is committed to helping patients defeat their cancer. We are advancing immune-oncology through the engagement of new and complementary phagocytic pathways that enhance anti-tumor efficacy and selectivity. Our lead compound is a first-in-class antibody targeting a novel macrophage immune checkpoint which is in multiple clinical trials across solid tumor and hematologic malignancies.

Essential Functions:

Responsible for the review of data listings, summary tables, and study results for multiple clinical trials/programs in oncology
Review and present data for scientific presentations on clinical trial results for internal and external purposes, manuscripts, and regulatory interactions in collaboration with the clinical development team
Assists in the preparation/review of regulatory documents, clinical protocols, IND annual reports, IND safety reports, Investigator Brochures and BLAs.
May serve as the primary or supporting medical monitor on clinical trials with appropriate medical backup
Participate in formulating the clinical development strategy including designing and implementing clinical trials and registrational plans in collaboration with the clinical development team
Plays a key role in management of site/investigator relationships including site initiation visits, investigator calls, and investigator meetings
Assists in generating company presentations regarding clinical development activities for internal and external stakeholders (i.e. core development teams, executive team, key opinion leaders)
Work with multiple functional teams to accomplish goals (i.e. clinical development, operations, pharmacology, biometrics, research and development, regulatory, CMC, and finance)

Education & Experience:

Advanced professional degree in health sciences (PhD in biosciences/clinical research/pharmacology, PharmD, or other equivalent)
3-5+ years of relevant scientific or drug development experience in industry to include trials experience
Background or work experience in oncology required
Ability to critically analyze and interpret scientific and clinical data and literature
Translational or clinical trials experience in immuno-oncology is a plus
Working knowledge of biostatistics, regulatory, clinical pharmacology and pharmacokinetics
working in an innovative therapeutic field

For more information on this role please forward an up to date resume to Lucy.Psaltis@cplphysicians.com

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