Senior Clinical Project Manager

Deciphera Pharmaceuticals Inc
  • Waltham, MA
    6 days ago

    Job Description

    Deciphera, a member of Ono Pharmaceutical Co., Ltd., is a biopharmaceutical company focused on discovering, developing, and commercializing important new medicines and providing hope to people living with cancer, neurologic and autoimmune disease. The spirit of collaboration that has brought medications to life continues to guide how we operate, grow, and discover new breakthroughs. We cultivate an inclusive culture that values curiosity, creativity, and shared accountability-empowering individuals to challenge the unknown together. Learn more about Deciphera, a member of Ono Pharmaceutical Co., Ltd., by visiting our website: https://deciphera.com

    The Senior Clinical Project Manager leads the execution of complex global clinical studies, providing hands-on operational leadership across study teams and external partners. This role is responsible for driving study execution, managing timelines and budgets, and ensuring trials are delivered with quality and in compliance with applicable requirements.

    The ideal candidate brings strong later-stage clinical trial experience, ideally including Phase III, and is comfortable taking ownership, working through challenges, and knowing when to engage others for support.

    Key Responsibilities:

    Clinical Trial Leadership & Execution

    • Lead the planning, execution, and delivery of assigned global clinical studies, with responsibility for timelines, budgets, quality, and overall operational execution.
    • Identify and address operational risks and challenges to keep studies on track.

    Cross-Functional Leadership

    • Lead cross-functional study teams, driving collaboration, accountability, decision-making, and problem-solving.
    • Partner across Clinical Operations, Data Management, Regulatory, Clinical Supply, and other functions to support global study execution.

    CRO & Vendor Management

    • Oversee CROs and external vendors, monitoring performance and ensuring alignment with study timelines, budgets, quality expectations, and contractual obligations.

    Stakeholder Communication & Operational Excellence

    • Communicate study progress, risks, and key decisions clearly to internal stakeholders and Clinical Operations leadership.
    • Contribute to Clinical Operations processes and ways of working that support efficient, high-quality study execution.

    Other duties and responsibilities as assigned

    • Bachelor's degree in health science or a related field and 8+ years of clinical research experience, including meaningful responsibility for managing complex clinical trials.
    • Strong global clinical trial and later-stage development experience, ideally including Phase III. Candidates with substantial experience leading large, complex Phase II studies will also be considered.
    • Demonstrated ability to lead and influence cross-functional study teams.
    • Hands-on experience managing CROs and vendors and proactively addressing operational risks.
    • Strong working knowledge of GCP, ICH, FDA, and applicable global clinical trial requirements.
    • Strong communication and problem-solving skills, with the ability to work independently, advocate for what is needed, and recognize when to engage others for support.

    Preferred Capabilities:

    • Phase III global study experience.
    • Oncology or rare disease clinical development experience.
    • Experience with eTMF, EDC, IWRS, and RBQM platforms.
    • Experience managing clinical study budgets and contracts.
    • Experience within a fast-paced biotechnology environment.
    • PMP certification or equivalent project management training.

    Role Specific Additional Information

    Due to the global nature of the role, there may occasionally be a need for early-morning or evening meetings to accommodate teams and partners across time zones.

    Travel of approximately 25% may be required, including travel to Boston approximately twice per year, as well as attendance at relevant conferences or study-related meetings.

    Deciphera believes in providing a fair, equitable, and competitive compensation and benefits package to all employees. Our base salary is just one component of Deciphera's competitive total rewards strategy that also includes annual performance bonus, a long-term incentive plan, full range of benefits and other incentive compensation plans (if applicable)

    Benefits:

    • Competitive salary and annual bonus.
    • Comprehensive benefits package including medical, dental, vision insurance, 401(k) retirement plan with company match, and more.
    • Generous parental leave and family planning benefits.
    • Outstanding culture and opportunities for personal and professional growth.

    EQUAL EMPLOYMENT OPPORTUNITY INFORMATION

    Deciphera is committed to equal employment opportunity and values diversity. To ensure that we comply with reporting requirements, we invite you complete the confidential survey at the end of this application. Providing this information is optional. It will not be accessible or used in the hiring process, and has no effect on your opportunity for employment. This information will also be treated confidentially. We are committed to make all hiring decisions and other employment decisions on a non-discriminatory basis.

    Numbers & Facts

    LocationWaltham, MA

    Skills

    • Autoimmune Diseaseunmatched
    • Biotech and Pharmaceuticalunmatched
    • Budget Managementunmatched
    • Budgetingunmatched
    • Cancerunmatched
    • Clinical Data Managementunmatched
    • Clinical Researchunmatched
    • Clinical Trialunmatched
    • Clinical Trial Managementunmatched
    • Communication Skillsunmatched
    • Conferencesunmatched
    • Contract Requirementsunmatched
    • Contract Research Organization (CRO)unmatched
    • Cross-Functionalunmatched
    • Diseaseunmatched
    • Drug Developmentunmatched
    • Electronic Data Capture (EDC)unmatched
    • FDA (Food and Drug Administration)unmatched
    • GCP (Good Clinical Practices)unmatched
    • Health Scienceunmatched
    • ICH Regulationsunmatched
    • Leadershipunmatched
    • Medical Productsunmatched
    • Medicationsunmatched
    • Neurologyunmatched
    • Oncologyunmatched
    • Operational Communicationsunmatched
    • Operations Managementunmatched
    • Operations Processesunmatched
    • Performance Analysisunmatched
    • Phase II Clinical Trialsunmatched
    • Problem Solving Skillsunmatched
    • Project Management Certificationunmatched
    • Project Management Professional (PMP)unmatched
    • Regulationsunmatched
    • Regulatory Complianceunmatched
    • Team Lead/Managerunmatched
    • Time Managementunmatched
    • Vendor/Supplier Evaluationunmatched
    • Vendor/Supplier Managementunmatched
    • Willing to Travelunmatched

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