The opportunity
As the Disease Area Head, you will play a pivotal role in shaping the product development strategy for immunology or neuroscience assets. Your responsibilities will span across clinical trial design, execution, and interpretation, ensuring the overall safety and efficacy of these products. You will collaborate with cross-functional teams, provide scientific leadership, and contribute to regulatory documents.
The Disease Area Head, Clinical Development is a critical leadership role, leading a team of physicians and scientists and responsible for providing the medical input and medical oversight within a therapeutic area(s). This may involve managing multiple assets or indications. Key strategic responsibilities include designing and executing clinical development plans for disease area across all stages of development. The incumbent will be responsible for leading clinical trials, developing and authoring/contributing to the essential documents (e.g. NDA/CTA submissions, study protocols, Investigator Brochures, regulatory briefing books and regulatory response documents, clinical study reports, etc.), reviewing study data and providing expert clinical insight.
The Disease Area Head will play a key role in cross-functional study teams, offering effective feedback and strategic insights. This position provides medical leadership within their field of expertise, contributing to Teva’s clinical development programs. Additionally, the role involves senior stakeholder management, regulatory interactions, and input at a broader R&D level, including business development opportunities. The disease area head will also work closely with the VP Cross TA lead to ensure alignment on clinical development strategy decisions and advancing clinical development objectives related to the specific disease area.
How you’ll spend your day
Directing and implementing clinical research plans and programs according to established design principles
Direct management of a team of physicians and clinical leads. Provide leadership guidance, responsible for the team members individual development, training, ensuring appropriate resource allocation, etc.
Drive the integration of clinical development strategies across the therapeutic area
Leading the development of Clinical Protocols to meet CDP objectives
Overseeing Study Director(s) and drive the execution of the study from protocol concept to final report including interpretation of clinical data
Overseeing the Medical Monitor(s) for a study or clinical program, reviewing and monitoring study safety data
Implementing strategies to identify, monitor and resolve clinical/program trial issues
Serving as the clinical/medical team expert to provide direction to all program team functions
Organizes Advisory Board meetings (e.g., agenda setting), and identifying and liaising with KOLs regarding program strategy and scientific advice
Interpreting study data and developing integrated summaries for safety and efficacy.
Contributing clinical expertise and content to regulatory documents (e.g. briefing books, NDAs, etc.)
Represent Clinical teams in discussions with Health Authorities
Setting key deadlines and project milestones within function
Reviewing 3rd party (contractors, consultants and vendors) work product and deliverables to approve payment of invoices and resolves issues
