Sumitomo Pharma

Title: Senior Clinical Data Associate Location: Remote US Full time Job Description: This position reports to the Associate Director, Clinical Data Management, Oncology and is part of the Oncology Data Management organization, which supports Sumitomo Pharma America’s clinical development programs by ensuring accurate, complete, and compliant clinical trial data. The Senior Clinical Data Associate (Sr. CDA) works in close partnership with Lead/Clinical Data Managers (LDM/CDM) and supports multiple oncology studies with increased independence and accountability. The role contributes directly to data quality, timeline adherence, and inspection readiness while collaborating closely with Clinical Operations, Safety, Biostatistics, and external vendors. Job Duties and Responsibilities - Perform end to end clinical data review activities, including query generation, review, follow up, and closure, in accordance with study specific guidelines and timelines. - Conduct in house data review and provide detailed feedback to the Lead/Clinical Data Manager or CRO Data Management team. - Support eCRF design, system validation activities, and ongoing EDC updates in collaboration with external vendors. - Assist in the development, review, and maintenance of Data Management documentation, including: - Data Management Plans (DMPs) - CRF Completion Guidelines - Data Validation Specifications / edit checks - Data Cleaning and Reconciliation Plans - Perform reconciliation activities (e.g., SAE reconciliation), raise and track associated queries, and escalate potential issues to Safety and Data Management leadership. - Support interim analysis and database lock activities, including focused data cleaning and reconciliation deliverables. - Support management of Lab Normal Ranges for studies with Local Labs. - Provide data management status updates to internal study teams in the absence of the Lead/Clinical Data Manager. - Take ownership of defined data management tasks or act as the primary Data Management contact for selected projects or study components. - Train and mentor junior Clinical Data Associates on assigned tasks and Data Management procedures. - Ensure strict adherence to Data Management standards, SOPs, and applicable regulatory requirements. - Perform other assigned duties in support of departmental objectives. Key Core Competencies - Solid understanding of clinical data management processes and clinical trial conduct under ICH/GCP. - Hands‑on experience with EDC systems, query management, data cleaning, and reconciliation workflows. - Strong attention to detail and ability to manage competing priorities across multiple studies. - Ability to work independently with minimal supervision while knowing when to escalate issues. - Effective written and verbal communication skills. - Strong collaboration skills in a matrixed, cross‑functional environment. - Demonstrated ability to mentor junior team members and share best practices. Education and Experience - Bachelor’s degree in life sciences or a related field required. - Minimum 3 years of clinical data management experience in the pharmaceutical or biotech industry. - Oncology experience preferred. - Ability to travel. The base salary range for this role is $84,900.00 - $106,100.00 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, in accordance with applicable law. 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 is involved. 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. Travel Requirements: Primarily remote role with periodic on-site meetings in office. Must be able to travel domestically and internationally as needed. Drug Screening Requirements Applicants for sales/field, manufacturing, or other designated roles will be required to submit to a pre-employment drug test. 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.

Title: Director, Clinical Research Location: TN, Nashville 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 or follow us on LinkedIn. Scope: Key role in leading, planning, executing clinical research activities in various indications through all stages of development, including post-marketing commitments. Key responsibilities: - Ownership of the key elements in planning and implementation of a clinical development program or programs in support of the overall product development plan, based on strong medical and scientific principles, knowledge of compliance and regulatory requirements, and emerging issues. - Support end-to-end clinical development planning; manage CDP, LRP, internal governance interactions. - Responsibility for project-related budget. - Oversee education of investigators, study site personnel, and study staff. - Responsible for participating in and leading clinical study teams, monitoring overall study integrity, and participate in review, interpretation, and communication of safety and efficacy data. - Responsible for SAB and DSMB relationships and interactions. - Present at program-related scientific, medical, and regulatory meetings. - Develop and maintain relationships with academic investigators, pharmaceutical partners/sponsors, KOL’s, and patient advocacy groups. - Contribute to planned regulatory filings including authoring clinical sections for IND, NDA, MAA, PIP, and other related documents. - Partner with Drug Safety & Pharmacovigilance to monitor the safety profile of compounds. - Maintain a high level of clinical and scientific awareness in the disease area(s) by reviewing the literature, attending medical/scientific meetings, and through personal interchanges with consultants, thought leaders, investigators, and internal stakeholders. - Co-author manuscripts and collaborate with cross-functional colleagues and thought leaders to meet publication plan objectives. - Maintain ethical standards of the highest level and have the knowledge and ability to comply with all relevant ethical, regulatory, and legal standards. - May participate in contributions to due diligence or other business development activity. - Participate in meetings and committees of parent company or other affiliates. - Establish collaborative and productive relationships with parent company colleagues, internal/external partners, and relevant affiliates. - Perform other duties as requested. Professional experience and qualifications: - 10+ years of pharmaceutical clinical research experience, additional experience in an academic setting advantageous. - Experience successfully executing global, multi-center, complex clinical research programs with minimal direction. - Deep knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials, and experience in implementation of clinical strategy and the design of study protocols. - Proven leadership skills and ability to bring out the best in others on a cross-functional team; highly collaborative, team oriented and decisive. - Experience authoring and reviewing global regulatory submissions required. - Experience with multiple therapeutic modalities (ex. small molecules, biologics, ATMPs). - Experience with Phase 4 clinical studies and various study modalities. - Experience and strength in data management an advantage. - Experience in Women’s Health preferred; CNS, Rare Disease experience beneficial. - Excellent communication and presentation skills are essential. - Advanced degree in life sciences, clinical pharmacology, or related discipline. - Clinical research certification or regulatory knowledge is beneficial - Professional English proficiency required, additional languages beneficial. The base salary range for this role is $192,320.00 - $240,400.00 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, in accordance with applicable law. 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 is involved. 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. Travel Requirements: Primarily remote role with periodic on-site meetings in office. Must be able to travel domestically and internationally as needed. Drug Screening Requirements Applicants for sales/field, manufacturing, or other designated roles will be required to submit to a pre-employment drug test. 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. 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

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 or follow us on LinkedIn. Job Overview We are currently seeking a dynamic, highly motivated, and experienced individual for the position of Territory Sales Manager – Specialty. As our Territory Sales Manager - Specialty, you will have a unique opportunity to be the face of Sumitomo Pharma America (SMPA) to our customers.  We reinforce a performance-based environment of ownership and accountability for our sales professionals by assigning each territory to one Territory Sales Manager. Job Duties and Responsibilities You will primarily be responsible for achieving and exceeding sales objectives and growing market share.  Specifically, you’ll: Manage the assigned territory. Establish deep and meaningful business relationships based on your clinical and market dynamic expertise. Increase market share base by closing new business in both new and existing accounts prioritized on market potential. Support your sales results with an exceptional level of clinical expertise and understanding of the evolving healthcare landscape, thoughtful planning, purposeful action, and utilization of your available resources in a compliant manner. Assess and analyze product/competitor trends and market dynamics. Collaborate and provide candid, constructive communication with team members. Travel is required throughout the territory. Overnight stays may be required, including meetings which may extend over several days (on occasion may include weekends) and require work during evening hours and/or overnight stays. Key Core Competencies Demonstrated success applying clinical expertise (product/competition/disease state), understanding of the healthcare landscape, and critical thinking. Demonstrated success analyzing trends and market dynamics to provide sales strategy recommendations and insights based on data. Demonstrated history of a strong work ethic and professional presence. Demonstrated ability to ensure all administrative tasks (including call reporting, sample management, expense reports, training modules, business plans, etc.) are completed in a timely, accurate and compliant manner. Demonstrated ability to consistently operate in a manner which demonstrates and instills trust and integrity. Ability to effectively work in a fast-paced start up environment. Ability to comply with customer institution access requirements. Preferred Qualifications: Experience working within Urology. Experience with a pharmaceutical launch. Knowledge of market access formulary positioning, including pull-through and push-through. Preferred Qualifications: Experience working within Urology. Experience with a pharmaceutical launch. Knowledge of market access formulary positioning, including pull-through and push-through. General Skills: Desire to be part of a rapidly evolving organization where you will showcase your decision-making, leadership, collaboration, and problem-solving skills. Passion to prove yourself as you develop, learn, and grow your knowledge, techniques, and skills. Superior written and oral communication skills. Proficiency with Microsoft Word, Excel, PowerPoint. Excellent interpersonal and collaborative skills, and the ability to work independently and effectively in a highly dynamic environment. Enthusiastic, driven, and able to adjust workload based on changing priorities. Demonstrated planning and flexibility skills to work across a variety of projects to meet goals and complete work on time. Value Competencies: Integrity and Compassion – Empathy, trustworthiness Bold Innovation – Inclusive mindset Achievement through Collaboration – Courageous communication The base salary range for this role is $113,600 to $142,000. 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.