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Associate Director, Pharmacovigilance Planning and Innovations

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Kailera Therapeutics

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Location:
United States , Waltham

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Category:
Research and Development

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Contract Type:
Not provided

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Salary:

160000.00 - 200000.00 USD / Year
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Job Description:

Reporting to the Senior Vice President, Patient Safety and Pharmacovigilance, this individual will play a critical role in ensuring the operational effectiveness, project planning, and cross-functional alignment of global patient safety and pharmacovigilance activities. Lead and support the integration of innovative technologies, drive process optimization, and other cross-functional initiatives from concept to adoption. Combine knowledge of pharmacovigilance practices with strong project management, stakeholder leadership, and business acumen.

Job Responsibility:

  • Coordinate and lead departmental planning activities for the PSPV organization including, e.g., headcount modeling, organizational design, and pharmacovigilance projects
  • Lead end-to-end project management for PV initiatives, including system implementations, process improvements, compliance programs, and organizational change efforts
  • Develop and maintain project plans, metrics, and dashboards to support PSPV strategies
  • Support resource forecasting, alliance management, and vendor oversight
  • Facilitate cross functional meetings, track actions, and ensure on-time execution of project deliverables
  • Communicate project updates to internal and external stakeholders through clear status reports, presentations, and dashboards
  • Ensure project outcomes align with PV strategy and broader corporate objectives
  • Build strong working relationships with cross functional leaders to support a proactive and collaborative safety culture
  • Manage and coordinate cross functional alignment for operational effectiveness and PV system/process evolution
  • Develop and maintain the pharmacovigilance innovation roadmap aligned with cross functional initiatives and compliance requirements
  • Assist with the development and implementation of innovative technical or procedural solutions to improve PSPV operational capabilities
  • Facilitate the maintenance of governance structures (e.g., Medical Safety Board)
  • Support in GCP and GVP inspection readiness and support audits

Requirements:

  • 10+ years of experience in biotech, pharma or CRO with a demonstrated focus on pharmacovigilance, drug safety, or related field
  • 3+ years of project or program management experience in a regulated environment
  • Demonstrated project management skills with strong analytical and problem-solving capabilities
  • Exceptional communication, stakeholder engagement, and change management skills
  • Strong interpersonal, organizational, and strategic planning skills
  • Experience working with outsourced vendors or Contract Research Organizations (CROs)
  • Experience leading or supporting process improvement
  • Adaptable to changing priorities and across multiple clinical trials and deliverables
  • Adept at communicating departmental vision, effectively aligning activities and performance to achieve functional area goals in alignment with corporate objectives
  • Proficient computer skills, including Word, PowerPoint, Excel, Visio, Power BI or similar
  • Proven experience working independently with minimal supervision
  • Knowledge of global safety and PV regulations, guidelines, and industry standards (FDA, EMA, ICH, GVP)
  • Bachelor’s degree or equivalent in Life Sciences, Public Health, Business or other related fields is required

Nice to have:

  • Experience in other areas of drug development such as regulatory affairs, quality assurance or alliance management
  • Hands-on experience with safety databases (e.g., Argus), PV quality systems, and regulatory inspections
  • Familiarity with AI/ML and NLP in regulated settings
  • MBA, PhD, PharmD, RN or Master’s degree are preferred
What we offer:
  • comprehensive health coverage
  • flexible time off
  • paid holidays
  • year-end shutdown
  • monthly wellness stipend
  • generous 401(k) match
  • tuition reimbursement
  • commuter benefits
  • disability and life insurance
  • annual bonus opportunities
  • equity grants

Additional Information:

Job Posted:
January 03, 2026

Employment Type:
Fulltime
Work Type:
Hybrid work
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