The opportunity
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 incumbent will have a lead professional role in cross functional study teams, providing, effective feedback and insight. This will be a key position providing Medical Leadership in their field of expertise to the organization. The position carries operational and strategic level responsibilities for providing the clinical development, scientific and medical input, oversight and leadership for Teva’s clinical development programs.
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)
The ideal person for this opportunity will need to be onsite in West Chester, PA 3 days a week
How you’ll spend your day
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.
