Vacancy expired!
CLINICAL TRIAL PHYSICIAN (REMOTE)LAWRENCEVILLE TOWNSHIP, NJ Candidates can be remote for this position. The position is in immuno-oncology, with a focus on lung at least. Project Description: The Clinical Research Physician sits within Clinical Development, which is a global organization dedicated to the effective design and execution of drug development. Clinical Development drives clinical development strategy, design, execution, and interpretation of clinical trials. The Clinical Research Physician:
- Serves as a primary source of medical accountability and oversight for clinical trials.
- Matrix management responsibilities across the internal and external network.
- Manages Phase 1 - Phase 3 studies, with demonstrated decision making capabilities.
- Provides medical and scientific expertise to cross-functional Client colleagues.
- Medical Monitoring
- Conducts medical data review of trial data, including eligibility review.
- Holds responsibility for site interactions in partnership with the Clinical Scientist (CS) for medical questions and education (including safety management guidelines).
- Holds responsibility for assessment of key safety-related serious adverse events in partnership with Worldwide Patient Safety and oversees safety narratives.
- Collaborates with CS and inputs into protocols, providing medical strategic oversight in protocol development (input on inclusion/exclusion and other safety-related clinical considerations).
- Fulfills Google Cloud Platform and compliance obligations for clinical conduct and maintains all required training.
- Clinical Development Expertise & Strategy
- Provides oversight and medical accountability for a group of studies.
- Participates in review of clinical study reports (CSRs).
- Leads the analysis of benefit/risk for clinical development protocols in a matrix team environment working with Clinical Scientists.
- Partners with CS to support executional delivery of studies (e.g., site activation, enrollment status, as well as adjudication for protocol violations, significant, non-significant deviations etc.)
- Identifies and builds relationships with principal investigators.
- Identifies and cultivates thought leaders in order to gain their inputs on emerging science in drug and biomarker research, disease knowledge, and design of clinical development studies and programs.
- Maintains a strong medical/scientific reputation within the disease area.
- Has in-depth knowledge of etiology, natural history, diagnosis, and treatment of the disorder.
- Keeps up-to-date in the disease area by attending scientific conferences and ongoing review of the literature.
- Keeps abreast of development and regulatory issues related to other competitive or relevant compounds in development and how our portfolio fits into the competitive landscape.
- Provides ongoing medical education in partnership with CS to allow for protocol-specific training, supporting the study team, investigators, and others.
- MD required (or ex-US equivalent).
- 3 or more years of Industry experience and/or clinical trials experience is required.
Vacancy expired!