Senior Medical Director, Clinical Research (Ophthalmology)

Overview

Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the U.S. (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma Canada, Inc.) and Europe (Sumitomo Pharma Switzerland GmbH) 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. For more information on SMPA, visit our website ( or follow us on (

Job Overview

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

Compensation and Benefits

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.

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.

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.

Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the U.S. (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma Canada, Inc.) and Europe (Sumitomo Pharma Switzerland GmbH) 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, a diverse pipeline of early- to late-stage assets, and in-house advanced technology capabilities, 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 (

Sumitomo Pharma America (SMPA) endeavors to make its application process accessible to all. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact SMPA at reasonableaccomodations@us.sumitomo-pharma.com

This contact information is for accommodation requests only and cannot be used to inquire about the status of applications.

At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company’s cultural pillars.

Our Mission

To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people worldwide

Our Vision

For Longer and Healthier Lives, we unlock the future with cutting edge technology and ideas

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