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Executive Medical Director, Pharmacovigilance, Gastrointestinal And Inflammation (Hybrid)

10+ years
282,100.00 - 443,300.00
10 Nov. 27, 2024
Job Description
Job Type: Full Time Education: MD/DO 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

Executive Medical Director, Pharmacovigilance – Gastrointestinal and Inflammation (GI²)

Location: Boston, MA
Company: Takeda Pharmaceuticals

This executive-level role centers on providing strategic leadership for Takeda’s Patient Safety and Pharmacovigilance (PSPV) function, focusing on the Gastrointestinal and Inflammation (GI²) therapeutic area. As a senior leader, you will manage medical safety activities for investigational and marketed compounds, oversee signal detection and risk management strategies, and directly influence cross-functional development and governance efforts.

You will play a pivotal role in advancing Takeda’s patient-focused vision by ensuring the highest standards in medical safety capabilities, mentoring physicians and healthcare professionals, and representing PSPV at company-wide and external committees.


Key Responsibilities

Leadership and Oversight

  • Lead safety management efforts, including oversight of Global Safety Leaders (GSLs) and PV Scientists for GI compounds in development and marketed.
  • Direct cross-functional Safety Management Teams (SMTs) and ensure comprehensive benefit-risk assessments for all products in the GI² therapeutic area.
  • Act as a deputy to the VP, Therapeutic Area Head, and provide senior leadership across PSPV functions.

Safety Strategy and Operations

  • Develop and implement innovative, patient-focused safety strategies.
  • Ensure effective medical safety evaluation processes, especially in preparation for regulatory submissions and safety update reports.
  • Anticipate regulatory trends, manage emerging safety signals, and develop contingency plans to address safety challenges.
  • Oversee safety activities involving external partners, including CROs and vendors.

Cross-Functional Influence and Communication

  • Represent GI² safety interests to internal governance bodies, such as the Takeda Safety Board, and external stakeholders, including regulatory authorities.
  • Provide safety expertise to cross-functional teams, including Development Operations, Regulatory Affairs, and Medical Affairs.
  • Ensure safety considerations are central to strategic decisions, including “go/no-go” milestones and product development plans.

Mentorship and Capacity Building

  • Mentor PSPV physicians and HCPs to strengthen safety monitoring, signal detection, and risk management capabilities.
  • Foster a culture of innovation and continuous learning within the PSPV function.
  • Contribute to global capacity planning and resource allocation for safety-related activities.

Qualifications and Skills

Education and Experience

  • Medical Degree (MD) required; advanced degrees preferred.
  • 10+ years of experience in pharmacovigilance, clinical research, or clinical development, with significant leadership in a global PV organization.
  • 5+ years in a senior management role, with demonstrated experience in mentoring and team-building.

Skills and Expertise

  • Expertise in international PV regulatory requirements (FDA, EMA, PMDA) and safety methodologies.
  • Proficiency in synthesizing complex data for benefit-risk analysis and safety decision-making.
  • Strong leadership and organizational skills, with the ability to inspire and manage global, cross-functional teams.
  • Experience managing partnerships with external vendors and CROs.
  • Advanced presentation and communication skills, with the ability to engage senior leadership and external stakeholders effectively.

Work Environment and Benefits

Position Type

  • Onsite or hybrid role based in Boston, MA.

Compensation

  • Base Salary Range: $282,100 - $443,300 (commensurate with experience, skills, and location).
  • Eligible for short-term and long-term incentives, along with a comprehensive benefits package.

Additional Benefits

  • Medical, dental, and vision insurance.
  • 401(k) plan with company match, tuition reimbursement, and paid volunteer time off.
  • Vacation and sick time accrual, company holidays, and well-being programs.

Why Join Takeda?

Takeda is a global pharmaceutical leader committed to transforming patient care through innovative therapies and best-in-class support programs. As a Global Top Employer, Takeda fosters an inclusive workplace that values diversity and collaboration while empowering employees to make a meaningful impact.

This role is an opportunity to lead at the forefront of patient safety and contribute to life-changing advancements in the GI therapeutic area.

For assistance with your application or interview preparation, feel free to ask!