Senior Director, Pharmacovigilance (Safety Science & Surveillance)

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

• 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.

• 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.

The base range for a Senior Director is $274,000 - $330,000 per year. Individual pay may vary based on additional factors, including, and without limitation, job-related skills, experience, work location, and relevant education or training. Kura's compensation package also includes generous benefits, equity, and participation in an annual target bonus.

#LI-RM1

• We work as one for patients
• We are goal-focused and deliver with excellence
• We are science-driven courageous innovators
• We strive to bring out the best in each other and ourselves

• 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!

Kura Oncology is a commercial-stage biopharmaceutical company committed to discovering and developing innovative precision medicines to help patients with cancer lead better, longer lives.

Through our deep understanding of cancer biology and decades of experience in precision oncology, we are studying the underlying causes of treatment resistance. This enables us to design smart combination regimens with other cancer therapies to target tumors from multiple directions, with the goal of improving long-term clinical benefit.

Kura developed and is commercializing KOMZIFTI™ (ziftomenib), the FDA-approved once-daily, oral menin inhibitor for the treatment of adults with relapsed or refractory NPM1-mutated acute myeloid leukemia, and continues to pioneer advancements in menin inhibition and farnesyl transferase inhibition. For additional information, please visit Kura’s website at www.kuraoncology.com and follow us on X and LinkedIn.

Kura Oncology is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. 

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