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Kura Oncology, Inc. logo
Kura Oncology, Inc.

Our mission is to realize the promise of precision medicines to help patients with cancer lead better, longer lives.

Senior Director, Pharmacovigilance – Safety Science, Surveillance

DirectorDirectorFull TimeRemoteSeniorTeam 51-200Since 2014H1B No SponsorCompany SiteLinkedIn

Location

Massachusetts

Posted

77 days ago

Salary

$274K - $330K / year

Seniority

Senior

Postgraduate Degree12 yrs expEnglish

Job Description

Senior Director, Pharmacovigilance – Safety Science, Surveillance

Kura Oncology, Inc.

• Provide strategic and operational leadership for global safety surveillance activities across Kura’s clinical and post-marketing programs. • Responsible for signal detection and evaluation, benefit-risk assessment, and safety surveillance strategies. • Ensure compliance with global pharmacovigilance regulations and drive proactive risk management to protect patients and support product development. • Partner cross-functionally with Clinical Development, Nonclinical, Regulatory Affairs, Biostatistics, and Quality to ensure robust safety oversight throughout the product lifecycle. • Lead the Safety Sciences/Surveillance function, setting strategies for signal detection, risk management, and aggregate safety reporting. • Drive the development and continuous evolution of safety signal detection methodologies and product-specific signaling strategies. • Oversee preparation and review of aggregate safety reports (DSURs, PSURs/PBRERs, aggregate reports for anticipated events).

Job Requirements

  • PharmD or PhD in life sciences preferred.
  • Advanced clinical or regulatory training highly desirable.
  • 12+ years of experience in pharmacovigilance or drug safety.
  • 5+ years in leadership roles within Safety Sciences, Signal Detection, or Safety Surveillance.
  • Experience supporting global regulatory submissions and health authority interactions preferred.
  • Strong background in oncology required.
  • Experience in both clinical development and post-marketing safety preferred.
  • Strong knowledge of signal detection methodologies and benefit-risk assessment.
  • Experience in the principles and techniques of data analysis, proficient in the use of data analysis/visualization software.
  • Working knowledge of industry standard safety databases, Regulatory databases, and other electronic data capture systems; working knowledge of MedDRA and WHODrug dictionaries.
  • Proven experience authoring and reviewing aggregate safety reports.
  • Demonstrate a deep understanding of and ensure compliance with current global PV regulations (FDA, EMA, CIOMS, ICH E2 guidelines).
  • Strategic thinker, a self-starter with strong scientific judgment.
  • Executive presence and ability to influence cross-functional stakeholders.
  • Excellent written and verbal communication skills.

Benefits

  • Career advancement/ development opportunities
  • Competitive comp package
  • Bonus
  • 401K + Employer contributions
  • Generous stock options
  • ESPP Plan
  • 20 days of PTO to start
  • 18 Holidays (Including Summer & Winter Break)
  • Generous Benefits Package with a variety of plans available with a substantial employer match
  • Paid Paternity/Maternity Leave
  • In-Office Catered lunches
  • Home Office Setup
  • Lifestyle Spending Stipend
  • Commuter Stipend (Boston Office)
  • Regular employee social activities, including happy hours, monthly birthday celebrations, Kura Koffee Talks, and much more!

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