Talent.com
Senior Director, Clinical Operations
Senior Director, Clinical OperationsSumitomo Pharma • Marlborough, MA, US
Senior Director, Clinical Operations

Senior Director, Clinical Operations

Sumitomo Pharma • Marlborough, MA, US
job_description.job_card.variable_hours_ago
serp_jobs.job_preview.job_type
  • serp_jobs.job_card.full_time
job_description.job_card.job_description

Senior Director, Clinical Operations

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.

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 1520 years (w / o Master's) or 1015 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.

    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.

    serp_jobs.job_alerts.create_a_job

    Director Clinical • Marlborough, MA, US

    Job_description.internal_linking.related_jobs
    Director, Clinical Operations

    Director, Clinical Operations

    Deciphera Pharmaceuticals • Waltham, MA, US
    serp_jobs.job_card.full_time
    The Director, Clinical Operations will ensure that clinical stage programs achieve program objectives within established timelines, budget, and quality standards. This role involves contributing to ...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Director, Clinical Operations

    Director, Clinical Operations

    Central Mass Health LLC • Worcester, MA, US
    serp_jobs.job_card.full_time
    Mass Advantage is a Medicare Advantage health plan, located in the heart of Worcester County, headquartered in Worcester MA. Mass Advantage is owned and designed by UMass Memorial Health providers w...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Interim Clinical Director

    Interim Clinical Director

    Promises Behavioral Health, LLC • Worcester, MA, US
    serp_jobs.job_card.temporary
    The purpose of this position is to oversee the clinical operation, program development and direct supervision of staff.The Interim Clinical Director of Residential Rehabilitation Services will be o...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_hours • serp_jobs.job_card.promoted • serp_jobs.job_card.new
    Arizona Licensed Clinical Systems Director

    Arizona Licensed Clinical Systems Director

    VirtualVocations • Worcester, Massachusetts, United States
    serp_jobs.job_card.full_time
    A company is looking for a Director, Clinical Systems.Key Responsibilities Lead and direct a team supporting clinical systems and oversee the system development lifecycle (SDLC) Manage the creat...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Director / Senior Director, Clinical Sciences

    Director / Senior Director, Clinical Sciences

    Cogent Biosciences • Waltham, MA, US
    serp_jobs.job_card.full_time
    Director / Senior Director, Clinical Sciences.Cogent Biosciences is a publicly traded biotechnology company focused on developing precision therapies for genetically defined diseases.The most advan...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Director of Clinical Information Systems

    Director of Clinical Information Systems

    Mangrove Management Partners • Burlington, MA, US
    serp_jobs.job_card.full_time
    Mangrove Management Partners and The Vascular Care Group is seeking an accomplished and strategic Senior Director, Clinical Information Systems, to lead the planning, governance, and optimization o...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    State Licensed Director of Clinical Excellence

    State Licensed Director of Clinical Excellence

    VirtualVocations • Lowell, Massachusetts, United States
    serp_jobs.job_card.full_time
    A company is looking for a Director, Clinical Excellence (Post Acute, VBC).Key Responsibilities Lead the operational delivery of the post-acute care program to ensure coordinated patient transiti...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_1_day • serp_jobs.job_card.promoted
    Director of Enhanced Care Management

    Director of Enhanced Care Management

    VirtualVocations • Worcester, Massachusetts, United States
    serp_jobs.job_card.full_time
    A company is looking for a Director of Enhanced Care Management.Key Responsibilities Direct and oversee operations of the enhanced care management program Supervise Clinical Managers, Clinical C...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_hours • serp_jobs.job_card.promoted • serp_jobs.job_card.new
    Director of Clinical Services

    Director of Clinical Services

    Advocates • Framingham, MA, US
    serp_jobs.job_card.full_time
    Advocates promotes a healthy work-life balance and offers many generous perks of employment and room for advancement.We are a strong-knit community that values the ideas and contributions of our st...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Clinical Trial Manager

    Clinical Trial Manager

    Apellis Pharmaceuticals, Inc. • Waltham, MA, United States
    serp_jobs.job_card.full_time
    The Clinical Trial Manager is responsible for the overall management, planning, implementation, and execution of clinical trial(s) in a fast-paced environment with moderate oversight from the Senio...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Director of Clinical Operations

    Director of Clinical Operations

    Promises Behavioral Health, LLC • Worcester, MA, US
    serp_jobs.job_card.full_time
    The Director of Clinical Operations will be responsible for championing the Clinical Vision for the assigned facility.This role will ensure compliance with all state and federal laws and regulation...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_hours • serp_jobs.job_card.promoted • serp_jobs.job_card.new
    Clinical Director, TSS, 37.5 Hrs, Day Shift

    Clinical Director, TSS, 37.5 Hrs, Day Shift

    UMass Memorial Health • Worcester, MA, US
    serp_jobs.job_card.full_time
    Umass Memorial Health Caregiver.Schedule Details : Monday through Friday, On Call - Required.Hours (United States of America). This position may have a signing bonus available a member of the Recruit...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Clinic Director (BCS-Lowell)

    Clinic Director (BCS-Lowell)

    Bridgewell • Lowell, MA, US
    serp_jobs.job_card.full_time
    Bridgewell delivers support through community housing, day programs, outpatient treatment, recovery services, education, and employment training. We're committed to helping people in need, from ...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Senior Director of Clinical Operations

    Senior Director of Clinical Operations

    VirtualVocations • Worcester, Massachusetts, United States
    serp_jobs.job_card.full_time
    A company is looking for a Senior Director, Clinical Operations.Key Responsibilities Ensure compliance with regulatory requirements and implement risk-based quality management across clinical stu...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Senior Director, Enterprise Projects and Initiatives Center

    Senior Director, Enterprise Projects and Initiatives Center

    Lantheus Brand • Bedford, MA, US
    serp_jobs.job_card.full_time
    Senior Director, Enterprise Projects And Initiatives Center.Lantheus is headquartered in Bedford, Massachusetts with offices in Canada, and Sweden. For more than 60 years, Lantheus has been instrume...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Assistant Director, Clinical Services

    Assistant Director, Clinical Services

    HFLW Brand • Walpole, MA, US
    serp_jobs.job_card.full_time +1
    Assistant Director, Clinical Services.Assist the Director of Clinical Services by providing clinical supervision for Clinicians, Clinical Coordinators at The Home in Walpole.Collaborate with fellow...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Senior Director / Executive Medical Director, Global Clinical Lead

    Senior Director / Executive Medical Director, Global Clinical Lead

    Wave Life Sciences • Lexington, MA, US
    serp_jobs.job_card.full_time
    Focus on the core content of the job post, removing any extra metadata, navigation mentions, and redundant headers.Keep the formatting beautiful and clean, ensuring high signal to noise ratio.serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Senior Manager, Clinical Operations

    Senior Manager, Clinical Operations

    ConvaTec • Lexington, MA, US
    serp_jobs.job_card.full_time
    Manager, Clinical Operations plays a key role to the success of Convatec's clinical trials.Manager, Clinical Operations oversees the management of the day-to-day operations of clinical trials, ensu...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted