Sumitomo Pharma Co., Ltd
Senior Medical Director, Clinical Research Neurology
US-Remote · Director
Sponsorship not specified$284k-$355kDetected 5 days ago
GCPData AnalysisStatisticsRecruitingClinical TrialsClinical ResearchFDA RegulatoryCRISPRPharmacovigilanceResearchExperimental DesignLeadershipCommunicationCollaboration
About the role
- 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.sumitomo-pharma.com or follow us on LinkedIn.
- The base salary range for this role is $284,320 to $355,400.
Responsibilities
- 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.
- Leads and drives strategy for clinical development programs for assigned asset(s) within the neurology therapeutic area.
- Leads or joins multi-disciplinary, multi-regional, matrix team through highly complex decisions.
- Responsible for and lead all activities related to clinical study design from study concept to study protocol for both early- and late-stage programs.
- 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.
- Review and provide input for the design of the statistical analysis plans, TLFs, and the clinical data output.
- Contributes to developing clinical components of BLA/NDAs, sNDAs, MAAs and other regulatory filing documents.
- Demonstrated ability to set clear priorities, lead, influence and build consensus in a multi-disciplined team environment.
Requirements
- Must be able to exercise appropriate judgment as necessary.
- Excellent written and oral communication skills required.
- Requires ability to use a personal computer for extended periods of time.
- 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.
Compensation
- The base salary range for this role is $284,320 to $355,400.
Benefits
- We are currently seeking a dynamic, highly motivated, and experienced individual for the position of Senior Medical Director, Clinical Research (Neurology) to join our R&D Organization.
- Provides oversight of clinical trial conduct, interacting with CROs, medical monitors, and vendors as required.
- Serve as the internal medical monitor for clinical trials.
- 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 company responses to health authorities and ethics committees for ongoing clinical development programs to ensure timely registration and initiation of trials globally.
- Contributes to the development of presentation materials for investigator meetings, health authority meetings, scientific advisory board meetings, and national and international scientific meetings.
- Ability to effectively synthesize, interpret and present scientific information to both internal stakeholders and external medical community.
Company info
- Serve as the subject matter expert for neurology, representing Clinical Research to both internal and external customers.
Equal opportunity
- Sumitomo Pharma America (SMPA) is an Equal Employment Opportunity (EEO) employer
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