Senior Director, Pharmacovigilance (Safety Science & Surveillance)
About The Position
Are you ready to join a team committed to making a meaningful impact on cancer treatment through the discovery and development of precision medicines? At Kura Oncology, you have an opportunity to be a part of something bigger, with a lasting impact that you can be proud of. At Kura Oncology, we are working to change the paradigm and improve the science of cancer treatment. As an organization, we strive to cultivate a diverse and talented professional culture driven to develop precision medicine therapeutics. As we continue to build a leading biotech organization with a strong culture, a patient-focused mindset and a team focused on relentless execution, we are looking for innovative, passionate professionals to join us and make our vision a reality. To succeed at Kura, you will need to have a demonstrated ability for excellence in drug discovery and development and a roll-up your sleeves attitude. The ideal candidate will possess a values-driven work style where integrity and grit drive all behaviors, decisions, and actions. The Senior Director of Pharmacovigilance (PV), Safety Sciences & Surveillance, provides strategic and operational leadership for global safety surveillance activities across Kura’s clinical and post-marketing programs. This individual is responsible for signal detection and evaluation, benefit-risk assessment, and safety surveillance strategies, for the company’s products. This role ensures compliance with global pharmacovigilance regulations and drives proactive risk management to protect patients and support product development. This position partners cross-functionally with Clinical Development, Nonclinical, Regulatory Affairs, Biostatistics, and Quality to ensure robust safety oversight throughout the product lifecycle
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.
Responsibilities
- Lead the Safety Sciences/Surveillance function, setting strategies for signal detection, risk management, and aggregate safety reporting.
- Lead safety strategy contributions to regulatory submissions, and lifecycle management strategies.
- Serve as safety lead on cross-functional governance committees (e.g., Safety Monitoring Committees).
- Drive the development and continuous evolution of safety signal detection methodologies and product-specific signaling strategies.
- Lead signal validation, prioritization, and assessment processes in alignment with global regulations; interpretation of safety signals and trends; communication of safety assessments (written and verbal) of safety risks in collaboration with other functional stakeholders.
- Provide strategic oversight for Risk Management Plans (RMPs), REMS (if applicable), and other risk minimization activities.
- Serve as safety representative in interactions with global regulatory authorities.
- Ensure inspection readiness and support health authority audits/inspections.
- Oversee preparation and review of aggregate safety reports (DSURs, PSURs/PBRERs, aggregate reports for anticipated events).
- Ensure alignment of safety messaging across clinical, regulatory, and medical communications.
- Provide strategic direction of safety content for key regulatory documents (e.g., DSURs, PSURs, IBs, protocols, RMPs) ensuring consistency and scientific rigor.
- Partner with Clinical Development on safety monitoring strategies and DMC interactions.
- Collaborate with Biostatistics on integrated safety analyses.
- Provide safety expertise to Medical Affairs and Commercial teams for post-marketing surveillance, as needed.
- Maintain oversight of safety vendors and CROs supporting surveillance activities.
- Contribute to SOP development and continuous improvement of PV systems and processes.
- Support inspection readiness activities, internal audits and external inspections.
- Mentor and develop a high-performing Safety Sciences team.
- Foster a culture of scientific rigor, accountability, and patient focus.
- Manage departmental budget and resource planning.
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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What This Job Offers
Job Type
Full-time
Career Level
Director
Education Level
Ph.D. or professional degree
