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    Senior Medical Director, Oncology Clinical Science

    Takeda Pharmaceutical
    7+ years
    Not Disclosed
    Boston
    10 Dec. 31, 2024
    Job Description
    Job Type: Full Time Education: MD/PhD Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Job Title: Senior Medical Director, Oncology Clinical Science

    Location: Boston, Massachusetts (Hybrid)
    Company: Takeda
    Job ID: R0137323
    Date Posted: October 22, 2024

    Job Overview:

    Takeda is seeking a Senior Medical Director, Oncology Clinical Science to join their team in Cambridge, MA. This role will lead the global clinical development strategy for multiple Takeda pipeline compounds in oncology, managing both the US/EU and Japan development teams. The Senior Medical Director will be responsible for overseeing clinical protocols, data interpretation, and ensuring regulatory approval of oncology products while guiding multidisciplinary teams through complex development decisions.

    Key Responsibilities:

    1. Clinical Development Leadership:

      • Lead the Global Development Team (US, EU, Japan) for assigned oncology compounds.
      • Direct the development strategy and execution of the Clinical Development Plan and protocols, ensuring alignment with regulatory requirements.
      • Monitor and interpret ongoing internal and external study data, making recommendations for global development decisions, such as “go/no-go” decisions and study design modifications.

    2. Study Execution and Interpretation:

      • Oversee activities related to the preparation, approval, and execution of clinical studies.
      • Provide guidance on clinical trial monitoring, ensuring successful project completion and risk mitigation strategies.

    3. Trial Medical Monitoring:

      • Oversee medical monitoring and ensure patient safety during clinical trials, collaborating with Pharmacovigilance on overall safety assessments.

    4. External Interactions:

      • Lead regulatory and clinical interactions with external authorities and key opinion leaders, advising clinical scientists and senior leadership.
      • Manage due diligence, business development, and alliance projects, evaluating scientific and regulatory feasibility for potential partnerships or acquisitions.

    5. Leadership and Team Development:

      • Mentor and manage a team of clinical scientists, fostering a positive and collaborative environment to achieve development goals.
      • Participate in high-priority task forces and leadership meetings, influencing decision-making across multiple regions.

    Qualifications:

    • Education:

      • MD, combined MD/PhD, or internationally recognized equivalent.

    • Experience:

      • Minimum of 7 years in clinical research within the pharmaceutical industry, CRO, health-related consulting, or biomedical/clinical academia.
      • Proven experience in leading clinical development teams across multiple regions, with a focus on oncology or malignant hematology.
      • Experience with NDA/MAA submissions and knowledge of global regulatory requirements.

    • Skills:

      • Strong leadership, strategic, and interpersonal skills.
      • Ability to influence decision-making in matrix teams and across different regions.
      • Expertise in therapeutic areas relevant to oncology and a deep understanding of the clinical development process.
      • Strong communication, problem-solving, and negotiation abilities.

    Compensation and Benefits:

    • U.S. Base Salary Range:
      The salary range will be based on experience, location, and qualifications.

    • Benefits:

      • Eligible for short-term and long-term incentives.
      • Medical, dental, and vision insurance.
      • 401(k) with company match, disability coverage, life insurance, tuition reimbursement, and paid volunteer time off.
      • Paid vacation and sick time, as well as company holidays and well-being benefits.

    Diversity and Inclusion:

    Takeda is committed to fostering a diverse workforce and ensuring equal employment opportunities for all individuals. We encourage applicants from all backgrounds to apply and provide a supportive environment for employees to thrive.

    Join Takeda’s mission to deliver better health and a brighter future to people around the world through innovation in oncology.

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