The Clinical Leader (CL) will lead the development and execution of clinical plan for a Ph3 program in autoimmunue Neurology disease areas. Specifically, the CL is responsible for the clinical development plans, protocol development, quality and timely execution of clinical studies, preparation and ownership of clinical study reports, leading the health authority meetings for clinical/medical issues and for the preparation and approval of essential documents for regulatory filings. The CL will lead the cross-functional clinical team and will manage direct reports who are project physicians or project scientists. The CL is a critical member in compound development team (CDT) and will interact with individuals from strategy leader (CDT Leader), clinical operation, project management, regulatory affairs, commercial, legal, quality assurance & compliance, CMC, biostatistics, global medical safety, clinical pharmacology and other scientific and business related disciplines. The CL is also expected to assist in the leadership of the evaluation of scientific opportunities in the therapeutic area.
Responsible for clinical development plans and has ownership for the design of clinical trials and for the content of clinical study reports
Interprets, reports and prepares results of product research in preparation for global health authority submissions
Responsible for medical monitoring/reporting and safety officer activities; Evaluates adverse events (pre and post-marketing) for relationship to treatment.
Acts as medical contact at company for global 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
Participates on and leads teams for 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 promotional materials
Manages the budget for all project related clinical activities
Responsible for managing and mentoring direct reports
An MD (or international equivalent) is required. Board Certification or Eligibility in neurology is preferred. Specialty training in neuromuscular or autoimmune diseases is a plus.
A minimum of 5 years Pharmaceutical Industry Drug Development or related experience is required. Experience leading a Phase III development program is required.
Global registration experience is preferred.
Experience in running trials in rare/orphan disease areas is a plus
Experience working in a Matrix environment with a collaborative spirit is required.