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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

The **Senior Director, Clinical Operations** is a member of the Clinical Operations leadership team, responsible for Risk-Based Quality Management, Operational Data & Analytics, Records Management and Inspection Readiness Strategies across all clinical studies in Phase 1-4. This individual provides strategic direction on all aspects of study monitoring and oversight for clinical studies within Clinical Operations which also includes implementing fit-for-purpose solutions, systems and processes. The ideal candidate will be knowledgeable for all aspects of clinical trials operations, Good Clinical Practice (GCP), and relevant regulatory guidelines.

Job Duties and Responsibilities

+ Ensure monitoring across all studies is conducted in alignment with regulatory requirements, leverages risk-based quality management methods and SMPA best practices

+ In collaboration with relevant functions, define and implement risk-based monitoring strategies including risk assessment methods, fit for purpose monitoring models, data analytics and centralized monitoring methods

+ Define and implement targeted strategies for oversight of CRO monitoring practices and serve as an escalation resource for study teams to ensure effective strategies/methods are in place

+ Maintain expert proficiency in systems and technology as applicable to central monitoring analytics, operational data collection, reporting, and access. Where possible, advise, implement and contribute to the design of novel systems in alignment with department and company data strategy/objectives.

+ Lead or contribute as the subject matter expert on department and cross-functional initiatives, workstreams, and process improvement efforts; contributing to the continuous enhancement to the clinical operations processes and ensuring clinical operations considerations are integrated effectively

+ Lead and/or oversee development and maintenance of relevant department SOPs, best practices, tools, and templates

+ Assist stakeholder teams with development and maintenance of relevant inspection-readiness processes and materials. May serve as a Clinical Operations representative for audits and regulatory inspections.

+ Lead and provide oversight of the Clinical Records Management (Trial Master File) team

+ Develop and/or review budgets for clinical operations department and assigned vendor budgets

+ Manage direct line reports, providing guidance, mentorship, and performance feedback to ensure their professional growth and the successful execution of their responsibilities

Key Core Competencies

+ Extensive knowledge of clinical development principles, theories and concepts and knowledge of pharmaceutical industry practices and standards, including GCP and ICH-Guidelines

+ Advanced proficiency in clinical operations monitoring and oversight, CRO-specific monitoring processes and working with leading CROs

+ Visionary in risk-based quality management, analytics and graphical visualizations as it pertains to clinical trial operational performance and/or clinical trial critical data compliance and quality

+ Experienced in systems/technology implementation and maintenance as it supports Clinical Operations, in particular, eTMF and Operational Data Modeling systems

+ Strong cross-functional communication with global partnerships, executive leadership, business/operational and technical colleagues with a solid awareness of key R&D functions

+ Innovative mindset capable of creating and implementing fit-for-purpose solutions and processes

+ Experience in clinical compliance and development of inspection readiness processes

+ Must have demonstrated working in a team environment and provide leadership in a management role

+ Must be tactful, mature, flexible, and have well-developed interpersonal skills. Ability to get along well with different personalities and to work well in teams.

+ High degree of organizational awareness and ability to understand interdependence and big picture

Education and Experience

+ Bachelor's or advanced degree, preferably in life sciences, pharmacy, or a related field.

+ Minimum 15 – 20 years (w/o Master’s) or 10 – 15 years (with Master’s) of relevant experience in biotech or pharmaceutical industry

The base salary range for this role is $222,320 to $277,900. 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 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 https://www.us.sumitomo-pharma.com 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 [email protected]

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_