Senior Director, Pharmacovigilance (Safety Science & Surveillance)
Kura Oncology, Inc.
6 months ago
Remote friendly (Boston, MA)
United States
Operations
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 knowledge of 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.
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 knowledge of 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.