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    Medical Director, Clinical Sciences

    Takeda Pharmaceutical
    3-5 years
    222,600.00 - 349,800.00
    Boston
    10 Nov. 27, 2024
    Job Description
    Job Type: Full Time Remote Education: MSc./M. Pharm/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

    Medical Director – Hematology, Neuroimmunology & Specialty Care (HNSC)

    Location: Boston, MA (or as specified in the job description)
    Department: PDT BU R&D

    About the Role

    The Medical Director – Hematology, Neuroimmunology & Specialty Care plays a pivotal role in leading the global clinical development strategy for products in Nephrology and Transplant Medicine. The position combines expertise in clinical research and medicine to drive innovation and patient-focused development of plasma-derived therapies for complex diseases.

    Key Responsibilities

    Clinical Development Leadership:

    • Lead global clinical development for products targeting Nephrology and/or Transplant Medicine, ensuring alignment with the overall global strategy.
    • Develop and maintain a Clinical Development Plan (CDP) and strategies that meet regulatory standards and support commercialization goals.
    • Drive critical evaluations of development strategies and adjust plans proactively to align with regulatory, scientific, and commercial landscapes.
    • Make key decisions regarding go/no-go milestones, study designs, and regulatory submissions that significantly impact product timelines and success.

    Protocol Development and Study Oversight:

    • Design, review, and approve clinical trial protocols and synopses.
    • Guide and support clinical scientists and teams in executing clinical studies.
    • Interpret and present clinical trial results, assessing their medical and scientific significance in the context of product strategy.

    Medical Monitoring:

    • Oversee medical monitoring for clinical trials, addressing protocol adherence and patient safety.
    • Collaborate with Pharmacovigilance to evaluate and manage safety information from ongoing studies.

    External and Regulatory Interactions:

    • Represent Takeda in discussions with regulatory authorities and key opinion leaders in Nephrology and Transplant Medicine.
    • Drive regulatory interactions, including preparation for submissions and responding to agency queries.

    Business Development and Alliances:

    • Evaluate in-licensing and collaboration opportunities, conducting due diligence on potential acquisitions or alliances.
    • Develop and negotiate clinical development plans with external partners, ensuring alignment with Takeda's strategic goals.

    Leadership and Collaboration:

    • Mentor and guide team members, fostering a collaborative and innovative culture.
    • Represent clinical development in high-impact internal and external forums, providing strategic input to research and business initiatives.

    Qualifications

    Education and Experience:

    • M.D. or internationally recognized equivalent degree required. Advanced degrees such as Ph.D. are desirable.
    • Board certification in Nephrology, Transplant Medicine, or a related specialty preferred.
    • 3–5 years of clinical research and drug development experience within the pharmaceutical industry required.
    • Experience leading clinical development teams and managing studies across multiple regions is highly desired.

    Skills and Knowledge:

    • Expertise in Nephrology, Transplant Medicine, or related specialties.
    • Proven understanding of global and regional regulatory requirements, GCP/ICH guidelines, and emerging trends in plasma-derived therapies.
    • Strong strategic, analytical, and interpersonal skills, with the ability to influence across functions and regions.
    • Knowledge of clinical trial design, data interpretation, and medical monitoring.

    Core Competencies

    • Leadership: Ability to drive cross-functional teams and align on global clinical development objectives.
    • Innovation: Identify process improvements and challenge the status quo to optimize development strategies.
    • Decision-Making: Assess complex, ambiguous situations and provide clear, data-driven solutions.
    • Communication: Exceptional verbal and written communication skills to convey ideas effectively to internal and external stakeholders.

    Travel Requirements:

    • Approximately 10–20% travel, including international trips for meetings, site visits, and regulatory interactions.

    Compensation and Benefits

    • U.S. Base Salary Range: $222,600–$349,800 annually.
    • Comprehensive benefits, including medical, dental, vision, 401(k), paid time off, and more.

    Why Takeda?

    Takeda is committed to creating a diverse workforce and driving innovation in the healthcare industry. As a Medical Director in our Plasma-Derived Therapies R&D group, you will play a vital role in transforming the lives of patients with complex diseases while advancing cutting-edge therapies.

    Equal Opportunity Employer: Takeda provides equal employment opportunities to all applicants without discrimination based on race, gender, religion, or other protected characteristics.

    #LI-Hybrid

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