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Associate Medical Director, Clinical Science, Gi Tau - Rheumatology

5+ years
185,500.00 - 291,500.00
10 Nov. 27, 2024
Job Description
Job Type: Full Time Education: MSc./M. Pharm/PhD/MD 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

This position at Takeda offers an exciting opportunity as an Associate Medical Director, Clinical Science in the Gastrointestinal & Inflammation Therapeutic Area Unit – Rheumatology, based in Cambridge, MA. The role focuses on leading clinical development strategies for pipeline compounds, with responsibilities spanning strategy development, execution, and external collaboration.


Key Role Highlights

Position Objectives:

  • Drive clinical development strategies for assigned compounds, ensuring alignment with Takeda's global objectives.
  • Lead multi-disciplinary, matrix teams to make impactful global decisions.
  • Act as a clinical/medical decision-maker, influencing R&D leadership and regulatory outcomes.

Primary Responsibilities

Clinical Leadership:

  • Team Leadership: Serve as Global Clinical Lead; guide clinical scientists and medical directors.
  • Strategic Alignment: Collaborate with Global Project Teams to create and execute Clinical Development Plans (CDPs) and protocols.
  • Impactful Decision-Making: Evaluate ongoing study data, assess implications, and make recommendations on go/no-go decisions.

Protocol and Study Management:

  • Oversee the development and approval of study synopses, protocols, and execution plans.
  • Provide leadership in the interpretation of study results and assess their impact on overall compound strategy.

Medical Monitoring:

  • Lead or oversee trial-related medical monitoring activities, ensuring subject safety and study integrity.
  • Collaborate with Pharmacovigilance teams to assess compound safety profiles.

External Engagements:

  • Lead interactions with key opinion leaders and regulatory authorities to support compound strategies.
  • Incorporate external advice into clinical plans and oversee the development of regulatory documents.

Business Development:

  • Conduct due diligence evaluations for business opportunities and alliances.
  • Lead clinical development negotiations for in-licensing or partnership projects.

Organizational Leadership:

  • Represent clinical science in cross-functional task forces and therapeutic area teams.
  • Mentor and develop staff, ensuring alignment with Takeda’s values and goals.

Qualifications

Education and Experience:

  • MD or internationally recognized equivalent.
  • Minimum 5 years of clinical research experience within pharmaceuticals, CROs, or academia.
  • Proven ability to lead matrix teams effectively.

Skills and Knowledge:

  • Expertise in GCP/ICH and global regulatory requirements.
  • Strong communication, strategic thinking, and problem-solving skills.
  • Proficiency in managing cross-functional, global teams.
  • Ability to predict challenges and develop contingency plans proactively.

Compensation and Benefits

  • Salary Range: $185,500 – $291,500 (dependent on experience and location).
  • Benefits:
    • Medical, dental, and vision insurance.
    • 401(k) match, paid vacation, and sick time.
    • Tuition reimbursement, life insurance, and wellness benefits.
    • Opportunities for short- and long-term incentives.

Work Environment

  • Hybrid work model (Cambridge, MA office).
  • Travel requirement of approximately 15–25%.

Diversity and Inclusion

Takeda is committed to fostering a diverse and inclusive workplace, ensuring equal opportunities for all employees regardless of background or characteristics.

If you're looking to contribute to transformative healthcare advancements in a dynamic, patient-focused environment, this role offers a perfect platform. Would you like assistance preparing for an application or discussing qualifications further?

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