Sumitomo Pharma America, Inc. is hiring a Senior Medical Director, Clinical Research Neurology to contribute to the design and execution of clinical development plans for assigned assets. You will serve as the Clinical Research Lead for stem cell and additional neurology programs.
What You'll Do
- Lead and drive strategy for clinical development programs for assigned asset(s) within the neurology therapeutic area.
- Lead or join multi-disciplinary, multi-regional, matrix teams through highly complex decisions.
- Be 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 oversight of clinical trial conduct, interacting with CROs, medical monitors, and vendors.
- Provide clinical input for and participate in study set up and design including data collection tools, data analysis, eCRF design, edit checks, and vendor database design plans.
- Conduct 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.
- Collaborate with the Pharmacovigilance department to ensure adequacy of safety monitoring and reporting.
- Review and provide input for the design of the statistical analysis plans, TLFs, and the clinical data output.
- Contribute to interpretation of clinical trial results and the writing of clinical study reports.
- Contribute to the preparation of Investigator Brochures, annual reports, data collection systems and final reports in compliance with appropriate scientific, regulatory, and medical standards.
- Contribute to developing clinical components of BLA/NDAs, sNDAs, MAAs and other regulatory filing documents.
- Contribute to company responses to health authorities and ethics committees for ongoing clinical development programs.
- Contribute to the development of presentation materials for investigator meetings, health authority meetings, scientific advisory board meetings, and scientific meetings.
- Serve as the subject matter expert for neurology, representing Clinical Research to both internal and external customers.
What We're Looking For
- MD (or international equivalent).
- Board certified or board eligible in neurology.
- A minimum of 5 years' experience in the pharmaceutical industry, with experience as Clinical Research Lead in neurology therapeutic area.
Nice to Have
- Fellowship training in epilepsy.
- Experience in pediatrics.
- Experience in regenerative cell medicine or gene therapy.
- Prior experience working with Japan organizations.
- Experience in regulatory submissions in US; preferred experience in Europe and Japan.
Team & Environment
You will work in a multi-disciplinary, multi-regional, matrix team.
Benefits & Compensation
- Compensation range: $284,320 to $355,400.
- Merit-based salary increases.
- Short incentive plan participation.
- 401(k) plan.
- Medical, dental, vision, life and disability insurances.
- Leaves provided in line with your work state.
- Flexible paid time off.
- 11 paid holidays plus additional time off for a shut-down period during the last week of December.
- 80 hours of paid sick time upon hire and each year thereafter.
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.
