Director, Global Clinical Physician

Senior Clinical Trial Physician, Rheumatology

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.

Key Responsibilities

• Serves as a primary source of medical accountability and oversight for multiple clinical trials or a single trial with significant complexity within the respective the 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.
• Will contribute 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 BMS colleagues
• Matrix management responsibilities across the internal and external network
• Manages Phase 2 to Phase 3 clinical studies, with demonstrated decision-making capabilities
• The role will include above disease / indication strategy work (i.e. Disease / Indication Strategy teams)
• The role will be foundational in working with teams in 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
• The role includes support of across portfolio activities in line with Clinical Excellence, including e.g. Protocol Review Committee, support of Business Development activities and Quality and Compliance leadership

Clinical Development Expertise & Strategy:

• A Clinical Trial Physician is a tenured drug developer who can independently design and construct clinical development plans and protocols with a strong strategic focus based on knowledge of asset/drug, disease area (rheumatology) and relevant science in order to meet regulatory and disease strategy targets.
• Done in conjunction with Clinical Development Program Lead or as a delegate when CDPL is not assigned
• Extensive experience in Research and Development (late and/or early development) and across various Phases of study design (FIH, study start-up, study execution, DBL & close-out)
• Oversees trial(s) within asset class or multiple trials across assets (ie Immunotherapy, targeted therapy, mABs, ADCs, CAR T, etc) & across various diseases with in-depth clinical development expertise
• Respected for Disease Expertise for rheumatology (internal to BMS and within the medical community)
• Disease Lead- able to serve as internal consultant for respective disease(s) based on scientific knowledge and therapeutic expertise
• Provides oversight and medical accountability for a group of high-priority 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.)
• Existing strong 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
• 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
• The CTP should be able to anticipate impact of external data which may shift internal clinical strategy and proactively assess needs for internal program (ie amendments, need for ad hoc analyses & implications to execution of internal programs)
• Provides ongoing medical education in partnership with collaborating Clinical Scientists to allow for protocol-specific training, supporting the study team, investigators, and internal stakeholders (ie medical affairs, commercial, translational medicine, access, etc)

Medical Monitoring:

• Leader of high performing Study Delivery Team (SDT) and key member of the Clinical Development Team (CDT)
• Study-Leader with ability to own/drive study level strategic decisions
• 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
• Onboarding Lead provides guidance and training to new CTP (not limited to data management; systems training), therapeutic training, innovative study design and sets example of high proficiency for the organization

Health Authority Interactions & Publications:

• Serves as medical point of expertise in key Health Authority interactions and advisory board meetings as Clinical Trial Physician
• Authors 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
• Experience with regulatory submission & development of clinical sections in regulatory documents for submission across several markets
• Ability to lead strategic framework for clinical sections of regulatory documents
• Exceptional clinical response strategist for queries (written & oral) Stakeholder Engagement and Communication

Will work closely with colleagues in BMS IO CT TRC, CT Correlative Research Team, Research & Discovery, Early and Late Development, Regulatory, Medical, Commercial and other key functional areas on a global basis; additionally, should have an external focus and build relationships with thought leaders, physicians, and patient advocacy groups outside of BMS. Be recognized internally and externally as an expert in the field.

Partner and interact with colleagues from Research and Early Development who design and implement first in human through proof-of-concept trials and will assure a seamless transition into late-stage development (Phase II-III trials.)

Ability to influence leadership and upper management of key functions (e.g., early development, TM, clinical pharmacology, toxicology, regulatory, HEOR, market access, medical affairs), applying foresight, scientific and development knowledge to ensure support of late clinical development needs and adequacy of clinical studies leading to registration

Qualifications & Experience

• MD (or ex-US equivalent), rheumatologist is required
• The ideal candidate will be a Clinical Drug Development leader; with greater than 5 years of extensive clinical trial and drug development experience and regulatory experience, in addition to a strong scientific background, particularly in rheumatology.
• Deep understanding of Biology, targets and translational science.
• Extensive experience of work with health authorities at all levels.
• The candidate also must be a highly effective leader capable of working with Commercial, Medical, and all research functions of the company from Research through Regulatory.
• The candidate must be comfortable with cross-functional drug and product development teams and managing in a matrix environment.
• Global experiences since this position has responsibility for strategy and clinical research in oncology in multiple geographies.

Key Competency Requirements:

• 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 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
• Ability to work independently & prioritize work (self-starter / takes initiative)
• Takes ownership and accountability
• Embodies collaborative-spirit, enterprise mindset & ability to see what's