Clinical Trial Physician

Responsibilities

• Contributes to and is a key member of a high performing Study Execution Team
• Conducts medical data review of trial data, including eligibility review
• Holds responsibility for site interactions in partnership with the Clinical Scientist (CS) and Clinical Development Lead (CDL) for medical questions and education
• Holds responsibility for assessment of key safety-related serious adverse events in partnership with Pharmacovigilance and oversees safety narratives, identification of safety signals and trends based on aggregate safety analyses
• Serves as 24-hour emergency medical contact (on rotational basis)
• Provides medical and scientific expertise to cross-functional BMS colleagues
• Participates and contributes to study safety committee meetings such as Safety Review Committees (SRC), Data Review Committees (DRC) and/or Data Safety Monitoring Boards (DSMBs)
• Fulfills GCP and compliance obligations for clinical conduct and maintains all required training
• Trains internal and external team members in clinical protocol and related study-specific materials, product-specific training, including Investigator Meetings and Site Initiation Visits (SIVs)
• Maintains regular communication with CDL and cross-functional team
• Identifies opportunities for streamlining MM workflows and works with appropriate parties to execute related initiatives

Clinical Development Expertise & Strategy

• Designs and develops clinical plans and protocols with a strong strategic focus based on knowledge of asset/drug, disease area and relevant science
• Oversees and medical accountability for one or more studies
• Supports 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
• Supports identification and cultivation of thought leaders 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
• 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/CDL to allow for protocol-specific training, supporting the study team, investigators, and others

Health Authority Interactions & Publications

• Contributes to key Health Authority interactions and advisory board meetings as Clinical Trial Physician
• Authors/drafts/edits clinical content for CSRs, regulatory reports, briefing books and submission documents to support closure, clinical narratives, reporting and filling of the study

Requirements

• MD required (or ex-US equivalent)
• 3 or more years of Industry experience and/or equivalent clinical trials experience is required