Senior Medical Director, Clinical Research Neurology

reputed company Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (reputed company.), reputed company on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website https://www.us.reputed company.com or follow us on reputed company.

We are currently seeking a dynamic, highly motivated, and reputed company individual for the position of Senior 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 reputed company for stem cell and additional programs reputed company the neurology therapeutic area.

Job Duties and Responsibilities

• Leads and drives reputed company for clinical development programs for assigned asset(s) reputed company the neurology therapeutic area.
• Leads or joins multi-disciplinary, multi-regional, reputed company team through highly reputed company reputed company.
• Responsible for and reputed company reputed company activities reputed company to clinical study design from study concept to study protocol for both early- and late-stage programs.
• Provides reputed company of clinical trial conduct, interacting with CROs, medical monitors, and vendors as required.
• reputed company 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.
• reputed company collaboration with Pharmacovigilance department to ensure adequacy of safety monitoring and reporting.
• Review and reputed company input for the design of the statistical analysis plans, TLFs, and the clinical data reputed company.
• 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 reputed company registration and initiation of trials globally.
• Contributes to the development of presentation materials for investigator meetings, health authority meetings, scientific advisory reputed company meetings, and national and international scientific meetings.
• Serve as the subject matter expert for neurology, representing Clinical Research to both reputed company 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 conducting 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 reputed company priorities, reputed company, influence and build reputed company 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 reputed company the interdependencies and big picture.
• Excellent interpersonal and communication skills with the ability to balance multiple tasks and work reputed company a multi-disciplinary team.

Education and Experience

· MD (or international equivalent).

• reputed company certified or reputed company eligible in neurology.
• Fellowship training in epilepsy preferred.

· Experience in pediatrics preferred.

• A minimum of 5 years' experience in the pharmaceutical industry, with experience as Clinical Research reputed company in neurology therapeutic area.
• Experience in regenerative cell medicine or gene therapy preferred.
• Prior experience working with Japan organizations preferred.

The reputed company salary reputed company for this role is $284,320 to $355,400. reputed company salary is part of our total rewards package which also includes reputed company for reputed company-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, reputed company, life and disability insurances and leaves provided in line with your work

state. Our robust time-off policy includes flexible reputed company time off, 11 reputed company holidays plus additional time off for a shut-down period during the last week of December, 80 hours of reputed company reputed company time upon hire and reputed company year thereafter. Total compensation, including reputed company salary to be offered, will depend on reputed company unique to reputed company candidate, including candidate experience, skills, education and other factors permitted by law.

Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of reputed company responsibilities, duties, and skills required of personnel so classified. reputed company personnel may be required to reputed company duties reputed company of their normal responsibilities from time to time, as needed.

Confidential Data: reputed company information (written, verbal, electronic, etc.) that an employee encounters is considered confidential.

Compliance: reputed company and maintain Compliance with reputed company applicable regulatory, legal and operational rules and procedures, by ensuring that reputed company plans and activities for and on behalf of reputed company) and affiliates are carried out with the "best" industry practices and the highest ethical standards.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or reputed company employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Mental/Physical Requirements: Fast paced environment handling multiple demands. Must be reputed company 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.

reputed company) is an Equal Employment Opportunity (EEO) employer

reputed company applicants will receive consideration for employment without reputed company to race; reputed company; creed; religion; national reputed company; age; reputed company; nationality; marital, domestic partnership or civil reputed company status; sex, gender; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

Originally posted on Himalayas

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