Senior Clinical Trial Physician, Rheumatology

Role Summary

The Clinical Trial Physician, Rheumatology, is the primary source of medical accountability and oversight for one or more clinical trials within the Global Drug Development organization. This position will provide the candidate an opportunity to significantly change the treatment of autoimmune diseases such as lupus, scleroderma, inflammatory myositis and/or rheumatoid arthritis with CAR-T cell therapy. The incumbent will be accountable, alongside the Clinical Development Program Lead, for the development of differentiated and strategic CDPs from phase 2-3 and potentially through to registrational execution. They will be foundational in working with teams in Research, Early and Late Development, providing insights into biology, translational elements, as well as overall benefit risk assessments. This role includes support of cross-portfolio activities in line with Clinical Excellence, including Protocol Review Committee, support of Business Development activities and Quality and compliance leadership.

Responsibilities

• Serves as a primary source of medical accountability and oversight for multiple clinical trials or a single trial with significant complexity within rheumatologic, autoimmune indications (lupus, scleroderma, myositis, rheumatoid arthritis)
• Work closely with hematology/oncology physicians to coordinate CAR-T cell therapy treatment in the context of autoimmune disease
• Supervises the development, monitoring, analysis, and interpretation of clinical trials and will supervise and have accountability for the clinical components of regulatory filings
• Contributes to overall Therapeutic Area disease strategy while ensuring an overall portfolio view
• Provides strategic insights into the clinical development plans
• Provides medical and scientific expertise to cross-functional colleagues
• Matrix management responsibilities across the internal and external network
• Manages Phase 2 to Phase 3 clinical studies, with demonstrated decision-making capabilities
• Includes above-disease/indication strategy work (Disease/Indication Strategy teams)
• Foundational work with Research, Early and Late Development teams to support ID 4/5 and PoC transitions, providing insights into biology, translational elements as well as overall benefit-risk assessments
• Supports cross-portfolio activities in line with Clinical Excellence, including Protocol Review Committee, Business Development activities and Quality and Compliance leadership

Qualifications

• MD (or ex-US equivalent), rheumatologist is required
• Greater than 5 years of extensive clinical trial and drug development experience with regulatory experience, and a strong scientific background in rheumatology
• Deep understanding of biology, targets and translational science
• Extensive experience working with health authorities at all levels
• Ability to lead with Commercial, Medical, and research functions across the company in a matrix environment
• Global experience with strategy and clinical research in oncology across multiple geographies

Skills

• Ability to communicate information clearly and lead presentations in scientific and clinical settings
• Subspecialty training in applicable therapeutic area desired
• Expertise in the scientific method to test hypotheses, including statistical design, analysis, and interpretation
• Expertise in the drug development process
• Experience executing effective clinical plans and protocols
• Strong leadership skills and ability to work independently in a team
• Ownership, accountability, and enterprise mindset; ability to see what's needed to be successful
• Travel: Domestic and international travel may be required

Education

• MD (or ex-US equivalent), rheumatologist is required