Senior Director, Clinical Leader - Milvexian

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Position Summary

The Clinical Leader (CL) is responsible for leading the team for a number of Milvexian level activities across all LIBREXIA clinical trials (IDMC, CEC etc.) and milvexian safety oversight across the program along with supporting other functional program needs. They will lead the Operational Alignment and Safety Integration Strategy Team (OASIS) for the LIBREXIA program within the CVMRPH Therapeutic Area. They will support the preparation of the compound and trial level documents, such as the Development Safety Update Report, Investigator Brochure, and Health Authorities and Ethics Committees/Institutional Review Board responses.  In this role they may serve as Molecular Responsible Physician.

The CL will lead their team to oversee and support the compound level safety and operational harmonization work across clinical trials, support   the Independent Data Monitoring activities, the Joint Safety Monitoring Team and the emergency hotline service, Clinical Events Committee, development, and updates of the Clinical Development Plan within Compound Development Plan. They will contribute to protocol development, preparation of clinical study reports, and for the preparation and approval of essential documents for regulatory filings. The CL may manage direct reports who are project physicians. They will operate in a matrix environment including external partners, and interact with different functions including project management, operations planning, project direction, regulatory affairs, data management, medical writing, biostatistics, benefit-risk management, pharmacogenomics, drug discovery, early clinical development, clinical pharmacology, clinical operations, health economics, epidemiology, worldwide medical affairs and other scientific and business-related disciplines. The CL is also expected to assist in the leadership of the evaluation of external scientific opportunities in the therapeutic area.

Major Duties & Responsibilities

• Responsible for medical monitoring/reporting and safety oversight; Evaluates adverse events (pre and post-marketing) for relationship to treatment and works closely with Global Medical Safety.
• Responsible for program medical monitoring/reporting and safety officer activities; Evaluates adverse events (pre and post-marketing) for relationship to treatment
• May support or assume responsibility for clinical development plans and participates in the design of clinical trials and development of the content of clinical study reports
• Interprets, reports and prepares results of product research in preparation for world-wide health authorities and submissions
• Assists Regulatory Affairs in determining requirement for any corrective actions or health authority reporting
• Acts as medical contact at company for worldwide health authorities concerning clinical/medical issues.
• Assists Regulatory Affairs in the development of drug/device regulatory strategies
• May act as company spokesperson regarding publication of clinical research findings and presentations to relevant global health authorities and advisory committees
• Helps explore and evaluate new product ideas to assist in identifying new marketing opportunities
• Supports general Clinical/Medical Affairs activities involving product evaluation, labeling and surveillance
• May support early clinical development and discovery activities involving product potential and development for registration
• Participates on evaluation of new product ideas, implement franchise business strategies, etc.
• Responsible for assessment of medical publications emerging from the Team and its affiliates; Responsible, with appropriate colleagues, for review of Company advertising and promotion
• Recruitment, supervision, and development of junior medical staff, assuring diversity of candidates
• Maintain personal knowledge of assigned therapeutic indication(s)
• Recruit, supervise, and develop junior medical staff, assuring diversity of candidates