Senior Director, Pharmacovigilance (Safety Science & Surveillance)

Essential Job Functions 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. Responsible for signal detection and evaluation, benefit‑risk assessment, and safety surveillance strategies. Ensures compliance with global pharmacovigilance regulations and drives proactive risk management to protect patients and support product development. Partners cross‑functionally with Clinical Development, Nonclinical, Regulatory Affairs, Biostatistics, and Quality for robust safety oversight throughout the product lifecycle. Strategic Leadership 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). Safety Surveillance & Signal Management Drive 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; interpret safety signals and trends; communicate safety assessments (written and verbal) of safety risks. Risk Management & Regulatory Strategy 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. Aggregate Reporting & Safety Communications 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. Cross‑Functional Collaboration 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. Compliance & Quality 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. Team Leadership 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. Job Specifications / Qualifications 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 background in signal detection methodologies and benefit‑risk assessment. Experience with principles/techniques of data analysis; proficient in data analysis/visualization software. Working knowledge of industry standard safety databases, regulatory databases, and electronic data capture systems; working knowledge of MedDRA and WHODrug dictionaries. Proven experience authoring and reviewing aggregate safety reports. Deep understanding of and ensure compliance with current global PV regulations (FDA, EMA, CIOMS, ICH E2 guidelines). Strategic thinker and self‑starter with strong scientific judgment. Executive presence; ability to influence cross‑functional stakeholders. Excellent written and verbal communication skills. Compensation / Benefits (if applicable) Base range for Senior Director: $274,000 - $330,000 per year. Compensation package includes generous benefits, equity, and participation in an annual target bonus. Kura Package includes: 401K + employer contributions, generous stock options, ESPP Plan, 20 days of PTO to start, 18 holidays, benefits package with substantial employer match, paid paternity/maternity leave, in‑office catered lunches, home office setup, lifestyle spending stipend, commuter stipend (Boston Office), and regular employee social activities. #J-18808-Ljbffr