Associate Clinical Scientist / Clinical Scientist
ResearchEd
Google Cloud Platform
Director, Early Clinical Development – Immunology, MD
Bristol Myers Squibb
full-time
Posted on:
Origin: • 🇺🇸 United States • California
Visit company websiteSalary
💰 $275,630 - $374,100 per year
Job Level
Lead
Tech Stack
Google Cloud Platform
About the role
- Serves as a primary source of medical accountability and oversight for multiple clinical trials from Phase I through Proof-of-Concept.
- Acts as an independent Medical Monitor for clinical trials and manages Phase I/II studies, providing medical and scientific expertise to cross-functional BMS colleagues.
- Articulates clinical development strategy and analyzes, interprets, and acts on clinical trial data to support development.
- Serves as principal functional author for regulatory submission, study reports, and publications; authors/drafts clinical content for CSRs and submission documents.
- Provides oversight and medical accountability for multiple trials across early development clinical lifecycle and manages site interactions in partnership with Clinical Scientists.
- Assesses key safety-related serious adverse events in partnership with Worldwide Patient Safety and oversees contributions to safety narratives.
- Contributes to and is a key member of Study Delivery Teams and Development Teams; collaborates on protocol development including inclusion/exclusion and safety considerations.
- Designs and develops clinical studies and research plans including first-in-human Phase I, proof of concept Phase I/II, entry registrational studies, biomarker qualification studies, and clinical pharmacology studies.
- Liaises with Clinical Scientists, Translational & Discovery Scientists and Development Teams to define dose, schedule, indications, and patient selection.
- Leads analysis of benefit/risk for clinical development protocols and partners to support executional delivery of studies (site activation, enrollment, adjudication of deviations).
- Maintains strong medical/scientific reputation within the disease area, keeps up to date via conferences and literature, and presents clinical strategy to senior leadership.
- Contributes to Health Authority interactions and advisory boards as Primary Clinical Representative for early development projects.
- Establishes external partnerships with academic centers, co-operative groups, vendors and government agencies; represents department in business development due diligence and partner alliance management.
Requirements
- Advanced degree(s) in relevant field: MD, MD/PhD (or x-US equivalent) and clinical expertise in a therapeutic area (e.g., attending level or international equivalent).
- Subspecialty fellowship training in applicable therapeutic area preferred.
- 5+ years of relevant experience in discovery, translational and/or clinical research in academic or industry setting including education where applicable.
- Ability to communicate and present information clearly in scientific and clinical settings.
- Expertise in the scientific method to test hypotheses, including statistical design, analysis, and interpretation.
- Knowledge of drug development process.
- Knowledge of the components needed to execute an effective clinical plan and protocols.
- Strong leadership skills with proven ability to lead and work effectively in a team environment.
- Fulfills GCP and compliance obligations for clinical conduct and maintains all required training.
- Domestic and International travel may be required.
