Teva Sr Director Clinical Development 

United States, Pennsylvania, East Bradford Township 

906981811

The Senior Director, Clinical Development is responsible for providing the medical input and medical oversight for an immunology or neuroscience clinical development program(s). Strategic responsibilities include scientific support design and execution of clinical development plans for the respective therapeutic or disease area through all stages of development The incumbent will be responsible for leading clinical trials, developing and authoring the necessary 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 input.The role may incorporate higher responsibilities in Senior Stakeholder Management, Regulatory interactions, and being able to provide input at wider R&D level for the company, acquire ad hoc various senior level responsibilities and assignments and contribute to licensing opportunities.

Travel Requirements: Travel expected (up to approximately 20% of business days)

Essential Duties & Responsibilities:

• Directing and implementing clinical research plans and programs according to established design principles
• Directing the integration of the Clinical Development Plan (CDP) and the Drug Development Plan
• Leading the development of Clinical Protocols to meet CDP objectives
• Serving as Study Director and driving the execution of the study from protocol concept to final report including interpretation of clinical data
• Serving as the lead Medical Monitor 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 project 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.)
• May 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.

Required:

• MD
• Minimum of 5 years’ experience in clinical development in immunology or neuroscience clinical research with solid knowledge and experience of overall and early clinical development in respective therapeutic area and involvement in clinical trial design or execution.
• A demonstrated competence and track record at Study Director/ Clinical Lead level.
• Experience with site engagement, handling responses from health authorities, IRBs. ethic commitees and investigator sites.
• Experience with FDA or EMA regulatory agencies handling responses to inquiries and requests for study related information desired. Submission experience is a plus.
• 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, 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 Vice President, Immunology or Neuroscience TA Head
• Ability to lead in a matrix environment

Specialized or Technical Knowledge Licenses, Certifications needed:

• Prefer board certified or board eligible, US or equivalent non-US, Medical or Pediatric subject matter expert in clinical immunology or neuroscience with solid knowledge and experience of overall late and early clinical development.

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