Senior Medical Director, Clinical Research

Senior Medical Director, Clinical Research (Ophthalmology) Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the U.S., Canada, and Europe focused on addressing patient needs in oncology, urology, women's health, rare diseases, psychiatry & neurology, and cell & gene therapies. With several marketed products in the U.S., Canada, and Europe, and a diverse pipeline of early- to late-stage assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. We are currently seeking a dynamic, highly motivated, and experienced individual for the position of Senior Medical Director, Clinical Research (Ophthalmology) 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 stem cell program within the Ophthalmology therapeutic area. Job Duties and Responsibilities: Responsible for and lead all activities related to clinical study design from clinical study concept to clinical study protocol for both early- and late-stage programs Leads or joins multi-disciplinary, multi-regional, matrix team through highly complex decisions Leads and drives strategy for clinical studies for assigned asset(s) within the Ophthalmology therapeutic area Provides oversight of clinical trial conduct, interacting with CROs, medical monitors, and vendors as required, and working with the safety group to ensure adequacy of safety monitoring and reporting 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 monitoring for clinical trials Review and provide input for the design of the 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 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 Serve as the subject matter expert for ophthalmology, 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 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 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: MD (or international equivalent) Board certified or board eligible in ophthalmology Fellowship training in vitreoretinal surgery (preferred) or retina A minimum of 5 years' experience in the pharmaceutical industry, with experience as Clinical Research Lead in Ophthalmology therapeutic area Experience in regenerative cell medicine or gene therapy preferred Prior experience working with Japan organizations is preferred The base salary range for this role is $284,320 to $355,400. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes 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. Total compensation, including base salary to be offered, will depend on elements unique to each 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 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. 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.