Teva Disease Area Head Immunology GI 

United States, Pennsylvania, East Bradford Township 

252027858

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.

• 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

• MD is required
• In depth knowledge of the disease area. Expertise in late-stage clinical trials. At least 5 years of relevant biopharmaceutical industry clinical development experience in immunology clinical research
• Solid knowledge and experience of overall and early clinical development
• In depth knowledge of the disease area, gastrointestinal is preferred
• Clinical experience and academic track record in a specific disease area is highly desirable. Completion of a disease area fellowship is also preferred
• Demonstrated competence and track record at Study Director/ Clinical Lead level
• Experience with FDA or EMA regulatory agencies handling responses to inquiries and requests for study related information desired
• Candidates should have experience and understanding of running clinical studies with substantial interaction with other Clinical Development functions such as Clinical Operations, Regulatory and Data Management and Program Leadership
• The ability to be a self-starter, self motivated and effective in influencing others
• The ability to provide guidance to Medical Monitors/ Clinical Scientists reporting into the Senior Vice President, Global Late Clinical Development
• Board certification or eligibility in the relevant disease area preferred
• Advanced knowledge and clinical training in medical/scientific areas
• Well-developed leadership skills with the ability to influence, able to make decisions and defend them. This individual will be highly visible at different levels of the organization and must be able to build trust and credibility.
• Ability to push innovation and creative thinking. Strategic thinking, accountable and forward-looking; able to see a larger business picture.
• Flexible, able to wear many hats, work in a fast-paced environment and be open to change or the unknown
• Excellent interpersonal, presentation and communication skills, highly collaborative
• Ability to interface professionally with a wide spectrum of internal and external academicians, agencies, and industry executives in the scientific/medical arena
• Hard working, energetic and passionate about making a difference
• Highest integrity, committed to ethics and scientific standards
• Taking initiative, thinking “on the fly”; hands-on, decisive and being self assured are critical
• Ability to work in a dynamic and global company
  

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