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Medical Director, Clinical Sciences

Takeda Pharmaceutical
Takeda Pharmaceutical
3-5 years
222,600.00 - 349,800.00
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.

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