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. Clinical Development drives clinical development strategy, design, execution, and interpretation of clinical trials.
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
#J-18808-Ljbffr
