[Hiring] Medical Director, Clinical Research @Sumitomo Pharma America, Inc.

Role Description

We are currently seeking a dynamic, highly motivated, and experienced individual for the position of Medical Director, Clinical Research (Neurology) to join our R&D Organization. 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.

• 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.

Qualifications

• 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.

Requirements

• 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.

Benefits

• Fast paced environment handling multiple demands.
• Must be able to exercise appropriate judgment as necessary.
• Requires a high level of initiative and independence.
• Excellent written and oral communication skills required.
• Requires ability to use a personal computer for extended periods of time.