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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 LinkedIn ( .
**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
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.
**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.
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.
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
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_

Bausch + Lomb (NYSE/TSX: BLCO) is a leading global eye health company dedicated to protecting and enhancing the gift of sight for millions of people around the worldfrom the moment of birth through every phase of life. Our mission is simple, yet powerful: helping you see better, to live better.
Our comprehensive portfolio of over 400 products is fully integrated and built to serve our customers across the full spectrum of their eye health needs throughout their lives. Our iconic brand is built on the deep trust and loyalty of our customers established over our 170-year history. We have a significant global research, development, manufacturing and commercial footprint of approximately 13,000 employees and a presence in approximately 100 countries, extending our reach to billions of potential customers across the globe. We have long been associated with many of the most significant advances in eye health, and we believe we are well positioned to continue leading the advancement of eye health in the future.
**Objective:**
Under the supervision of the Director or designee of Clinical Operations, responsible for overseeing the implementation of clinical studies to ensure that they are conducted according to the Investigational Plan and all applicable regulations. Provide clinical and technical expertise for Clinical Programs and Marketing Investigations, including on-site support.
**Key Activities:**
+ Leads or collaborates on required tasks prior to commencement of clinical trials that include, but are not limited to: clinical planning, protocol development, case report form (CRF) development, IRB submissions, investigator agreements, informed consent form (ICF) development, site selection and communication with senior clinical trial sites regarding all logistics including contract agreements, support materials and training.
+ Provides clinical oversight and management for clinical trials to facilitate compliance with FDA and other applicable international regulatory requirements and company standard operating procedures (SOPs) during all company clinical investigations and post-market studies.
+ Communicates with vendors and clinical trial sites regarding study conduct, data monitoring, logistical management of follow-up, and close out study visits to ensure compliance with protocols and GCP requirements.
+ Collaborates on clinical data processing in accordance with departmental SOPs and guidelines.
+ Verifies, reviews, and tracks CRFs and generates Data Clarification Forms (DCFs) for all missing or inaccurate data; ensures that data changes are correctly implemented and captured in the database or data system.
+ Assists in the evaluation and analysis of clinical trial data to facilitate the completion of clinical trial reporting requirements, including report writing, clinical photo-documentation, FDA and manuscript submissions.
+ Assists in tracking study-specific payments.
+ Provides operational or workflow support to ensure that departmental and cross-functional systems and procedures are efficiently and correctly completed.
+ Collaborates on project teams, primarily with Clinical Operations, Research and Development, Safety, Clinical Trial Materials, Marketing, Regulatory, and Quality/Compliance.
+ Liaising between internal and external stakeholders to facilitate cooperation of others.
+ Conducts presentations of clinical information concerning specific projects.
**Requirements:**
+ Bachelors degree in a health profession or science. Advanced degree preferred.
+ 5 years of on-going clinical trials experience.
+ Demonstrated proficiency in knowledge of GCPs and knowledge of FDA regulatory requirements.
+ Knowledge of medical terminology.
+ Ability to effectively work independently.
+ Excellent verbal and written communication skills, computer proficiency (Word, Excel, Outlook), and data management experience.
**We offer competitive salary & excellent benefits including:**
+ Medical, Dental, Eye Health, Disability and Life Insurance begins on your hire date
+ 401K Plan with company match and ongoing company contribution
+ Paid time off vacation (3 weeks - prorated upon hire), floating holidays and sick time
+ Employee Stock Purchase Plan with company match
+ Employee Incentive Bonus
+ Tuition Reimbursement (select degrees)
+ Ongoing performance feedback and annual compensation review
This position may be available in the following location(s): ((location_obj))
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
For U.S. locations that require disclosure of compensation, the starting pay for this role is between $100,000.00 and $150,000.00. The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors.
U.S. based employees may be eligible for short-term and/or long-term incentives. They may also be eligible to participate in medical, dental, vision insurance, disability and life insurance, a 401(k) plan and company match, a tuition reimbursement program (select degrees), company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive sick time, floating holidays and paid vacation.
Job Applicants should be aware of job offer scams perpetrated through the use of the Internet and social media platforms.
To learn more please read Bausch + Lomb's Job Offer Fraud Statement ( .
Our Benefit Programs:Employee Benefits: Bausch + Lomb ( must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.