Senior Clinical Trial Physician/Clinical Trial Physician (Pulmonology)

Role Summary

The Senior Clinical Trial Physician/Clinical Trial Physician (Pulmonology) sits within Clinical Development and provides medical accountability and oversight for multiple clinical trials across Phases 1–3. The role requires matrix management across internal and external networks, medical and scientific leadership for cross-functional colleagues, and ongoing medical strategy to meet regulatory and disease strategy targets in pulmonology programs.

Responsibilities

• Serves as a primary source of medical accountability and oversight for multiple clinical trials; manages matrix relationships across internal and external networks
• Manages Phase 1 – Phase 3 studies with demonstrated decision-making capabilities
• Provides medical and scientific expertise to cross-functional colleagues
• 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)
• Conducts medical data review of trial data, including eligibility review where applicable
• 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 GCP and compliance obligations for clinical conduct and maintains all required training
• 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 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 with Clinical Scientists (CS)
• Partners with CS to support executional delivery of studies (site activation, enrollment status, and adjudication for protocol violations and deviations)
• Identifies and builds relationships with principal investigators and thought leaders to input on emerging science, biomarker research, disease knowledge and study design
• Maintains a strong medical/scientific reputation in the disease area with in-depth knowledge of etiology, natural history, diagnosis, and treatment, supported by conference attendance and literature review
• Keeps abreast of development and regulatory issues related to other compounds and how the portfolio fits into the competitive landscape
• Provides ongoing medical education with Clinical Scientists to support protocol-specific training for the study team, investigators and others
• Health Authority Interactions & Publications: contributes as medical point of expertise in Health Authority interactions and advisory board meetings
• Authors/drafts clinical content for CSRs, regulatory reports, briefing books and submission documents in partnership with CSs

Qualifications

• Required: 3 or more years of industry experience and/or clinical trials experience
• Preferred: Subspecialty training in pulmonology

Skills

• Ability to communicate information clearly and lead presentations in scientific and clinical settings
• Expertise in the scientific method to test hypotheses, including statistical design, analysis, and interpretation
• Expertise in drug development process
• Expertise in 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

Education

• MD required (or x-US equivalent)

Additional Requirements

• Domestic and International travel may be required