Medical Director, Clinical Research Neurology

This individual will contribute to the design and execution of clinical development plan(s) for assigned asset(s) and serve as the Clinical Research Lead for programs within the neurology therapeutic area.

Job Duties and Responsibilities

• Leads critical workstreams and drives execution of clinical development programs for assigned asset(s) within the neurology therapeutic area.
• Responsible for and lead activities related to clinical study design from study concept to study protocols for programs across all stages of development.
• Provides subject matter expertise and acts as a key contributor to clinical development strategy for assigned asset(s) within the neurology therapeutic area.
• Acts as SME and provides leadership in multi-disciplinary, multi-regional, matrix team through highly complex decisions.
• Provides oversight of clinical trial conduct, interacting with CROs, medical monitors, and vendors as required.
• Provide clinical input for and participate in study set up and design including data collection tools, data analysis, eCRF design, edit checks, vendor database design plans, etc.
• Study-level, site-level and subject-level data review and interpretation, including documentation and summarization of findings.
• Serve as the internal medical monitor for clinical trials.
• Close collaboration with Pharmacovigilance department to ensure adequacy of safety monitoring and reporting.
• Review and provide input for the design of statistical analysis plans, TLFs, and the clinical data output.
• Contributes to interpretation of clinical trial results and the writing of clinical study reports.
• Contributes to the preparation of Investigator Brochures, annual reports, data collection systems and final reports in compliance with appropriate scientific/regulatory/medical standards.
• Contributes to developing clinical components of BLA/NDAs, sNDAs, MAAs and other regulatory filing documents.
• Contributes to company responses to health authorities and ethics committees for ongoing clinical development programs to ensure timely registration and initiation of trials globally.
• Responsible for KOL network development, SAB coordination and strategy, development of presentation materials for investigator meetings, health authority meetings, and national and international scientific meetings.
• Serve as the subject matter expert for neurology, representing Clinical Research to both internal and external customers.
• 20% domestic and international travel.

Key Core Competencies

• Knowledge and understanding of FDA, GCP, and ICH regulations and guidance.
• Thorough and up-to-date knowledge of therapeutic area including trends, advances, understanding of currently available therapies and competitive clinical landscape.
• Experience in global clinical trials in both early- and late-stage clinical development, especially protocol development and trial initiation.
• Experience in regulatory submissions in US; preferred experience in Europe and Japan.
• Demonstrated ability to set clear priorities, lead, influence and build consensus in a multi-disciplined team environment.
• Strong team leadership skills and ability to motivate large multi-functional teams.
• Ability to effectively synthesize, interpret and present scientific information to both internal stakeholders and external medical community.
• High degree of organizational awareness, ability to connect the dots to understand all the interdependencies and big picture.
• Excellent interpersonal and communication skills with the ability to balance multiple tasks and work within a multi-disciplinary team.

Education and Experience

• MD (or international equivalent).
• Board certified or board eligible in neurology.
• Fellowship training in epilepsy required.
• Experience in pediatrics preferred.
• A minimum of 1-2 years' experience in the pharmaceutical industry contributing to clinical research strategy in neurology therapeutic area.
• Experience in regenerative cell medicine or gene therapy preferred.
• Prior experience working with Japan organizations preferred.