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Senior Clinical Trial Physician Cell Therapy - Bothell, United States - KLM Bryant Research
2 weeks ago
Description
Title:
Senior Clinical Trial Physician Cell Therapy
Region:
Europe,Northeast
Specialty:
ONCOLOGY,PHARMACOVIGILANCE
Function:
BIOTECHNOLOGY,CLINICAL DEVELOPMENT,CLINICAL RESEARCH
Degree:
MD,MEDICAL DEGREE
Salary:
0+
Description:
The Senior Clinical Trial Physician sits within Clinical Development, which is a global organization dedicated to the effective design and execution of drug development.
Position Summary / Objective
Serves as a primary source of medical accountability and oversight for multiple 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 colleagues
Position Responsibilities
Medical Monitoring
Contributes to and is a key member of a high performing Study Delivery Team (SDT) and may be a member of the Clinical Development Team (CDT)
Leads 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
Leads collaboration with CS and inputs into protocols, providing medical strategic oversight in protocol development (input on inclusion/exclusion and other safety-related clinical considerations)
Fulfills GCP and compliance obligations for clinical conduct and maintains all required training
Clinical Development Expertise & Strategy
In collaboration with the Clinical Development Lead, designs and develops clinical plans and protocols with a strong strategic focus based on knowledge of asset/drug, disease area and relevant science in order to meet regulatory and disease strategy targets
Provides oversight and medical accountability for a group of studies
Leads the analysis of benefit/risk for clinical development protocols in a matrix team environment working with Clinical Scientists (CS)
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. Holds strong expertise 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 collaborating Clinical Scientists to allow for protocol-specific training, supporting the study team, investigators, and others
Health Authority Interactions & Publications
Contributes to and serves as medical point of expertise in key Health Authority interactions and advisory board meetings as Senior Clinical Trial Physician
Authors/drafts clinical content for CSRs, regulatory reports, briefing books and submission documents to support closure, clinical narratives, reporting and filling of the study in partnership with CSs
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