高级医学总监, 临床研究 神经学

Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused 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 or follow us on LinkedIn.
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.
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
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.

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 all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.
Confidential Data: All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential.
Compliance: Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) 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 continued 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 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.
Sumitomo Pharma America (SMPA) is an Equal Employment Opportunity (EEO) employer
Qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union 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