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Director, Clinical Research Scientist

Posted on March 4, 2026

Remote, United States of America
196700.0 - 245900.0 USD (yearly)

Full Time

Director, Clinical Research Scientist job opportunity

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

https://www.us.sumitomo-pharma.com

Job Overview

The Director, Clinical Research Scientist role is an exciting opportunity for a highly motivated individual to be a key contributor to the development and execution of the clinical strategy across the oncology portfolio. This individual will manage a Clinical Development Clinical Research Scientist team to support early and late-stage clinical development to have a strategic and scientific impact on current and future clinical programs. This highly visible key role offers outstanding career and personal development opportunities for motivated candidates.

Job Duties and Responsibilities

Train Clinical Research Scientists to execute clinical trials in collaboration with clinical operations and medical directors to support study start up, present at SIV, develop deep relationships with Principal Investigators, review eligibility forms, support trials with intensive monitoring support, data review, and data cleaning.
Lead, recruit and train a team of Clinical Research Scientists with diverse backgrounds and experience to meet the needs of the evolving business.
Train Clinical Research Scientists to support NDA submissions and all regulatory responses.
Support corporate goals by working closely with Senior Management.
Provide strategic support and direction for clinical drug development programs through close interactions in a cross-functional environment by offering scientific and clinical guidance and expertise.
Provide support for advisory boards, consultant, and investigator meetings, including the preparation and/or delivery of presentations.
Understand the competitive landscape and provide insights on strategic development pathways.
Keep abreast of oncology treatment modalities, drug mechanism of action, approaches to drug development, and regulatory requirements.
Proactively seek out and recommend process improvements.
Provide development, coaching, and mentorship to direct reports in support of building a high-performing team.
As necessary, perform medical review of data for safety and efficacy evaluation.
Collaborate with the project team on the review, analysis, and interpretation of study results, including exploratory endpoints and assuring appropriate data review and accurate data reporting.
Contribute to drafting manuscripts and other publications and presentations.

Key Core Competencies

People leadership: Demonstrate coaching skills to develop team.
Cross-Functional Leadership in a matrix environment: Build alignment and drive outcomes through collaboration with Clinical Operations, Medical Directors, Biometrics, Clinical Pharmacology, Regulatory, Pharmacovigilance/Safety, Medical Writing, and other stakeholders without relying on direct authority.
Agility, Resilience, and Change Leadership: Remain effective in a fast-paced environment; adapts to priorities quickly, manages ambiguity, and guides the team through an evolving program while maintaining delivery excellence.
Global and Cross-Cultural Effectiveness: Must work effectively across different cultures and regions and maintain diverse and effective teams.
Scientific Rigor and Clinical Judgment: Apply a deep knowledge of oncology and strong clinical reasoning to guide study design, endpoint selection, safety and efficacy evaluation, and interpretation of complex data.
High degree of organizational awareness, ability to connect the dots to understand all the interdependency and big picture.

Education and Experience

BS/MS/PhD in a related life science discipline or PharmD; RN, BSN or MSN preferred.
Minimum of 10 years of clinical development experience in the pharmaceutical/biotech industry (clinical science, medical writing, etc.)
Prior oncology drug development experience required.
Prior experience leading a Clinical Research Scientist team through study design and startup, as well as NDA submission and approval process.
The candidate will have clinical experience in an oncology clinic, and leading a team through NDA, establish data visualization tools, deliver high touch support of sites in multiple regions.
Experience in the analysis and interpretation of clinical data (safety and efficacy) and a working knowledge of biostatistics, GCP, and regulatory requirements for clinical studies.
Patient profile and data listing review experience.
Must possess strong analytical, problem-solving, and scientific writing skills.
Excellent oral and written communication skills and solid PowerPoint, Word, and Excel.
High level of organizational and project management skills.
Demonstrated ability to work independently in a matrix environment with the ability to prioritize and manage multiple tasks simultaneously.
Demonstrated ability to influence through collaboration.
Flexibility to accommodate changes in priorities and project needs.
Prior experience performing Medical Review and writing/updating core development documents (e.g., protocols, CSRs, IBs, and ICFs) are required.
Willing to serve as a mentor/advisor or support person for junior colleagues; leads by example with a strong work ethic and respect for colleagues.
Willingness to be very “hands-on” in a fast-paced work environment and ability to reprioritize as needed.

The base salary range for this role is $196,700 to $245,900. 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

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.

Our Vision and Culture

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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