Senior Director, Pharmacovigilance (Safety Science & Surveillance)
Kura Oncology, Boston, MA, United States
Senior Director, Pharmacovigilance (Safety Science & Surveillance)
Boston, Massachusetts or Remote
Join a team committed to making a meaningful impact on cancer treatment through the discovery and development of precision medicines. A leading biopharmaceutical organization focused on patient‑centric, precision‑medicine therapeutics seeks an innovative, passionate professional to join our vision.
ESSENTIAL JOB FUNCTIONS The Senior Director of Pharmacovigilance provides strategic and operational leadership for global safety surveillance across Kura’s clinical and post‑marketing programs. Responsibilities include signal detection and evaluation, benefit‑risk assessment, safety surveillance strategies, and compliance with global pharmacovigilance regulations.
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 such as Safety Monitoring Committees.
Safety Surveillance & Signal Management
Develop and evolve safety signal detection methodologies and product‑specific signaling strategies.
Lead signal validation, prioritization, and assessment processes in line with global regulations; interpret safety signals and trends and communicate safety assessments (written and verbal) with stakeholders.
Provide strategic oversight for Risk Management Plans (RMPs), REMS (where 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, etc.).
Ensure alignment of safety messaging across clinical, regulatory, and medical communications.
Provide strategic direction of safety content for key regulatory documents 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.
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.
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
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.
Proficient data‑analysis/visualization skills and familiarity with MedDRA/WHODrug dictionaries.
Proven experience authoring and reviewing aggregate safety reports.
Deep understanding of current global PV regulations (FDA, EMA, CIOMS, ICH E2 guidelines).
Strategic thinker, self‑starter with strong scientific judgment.
Executive presence and ability to influence cross‑functional stakeholders.
Excellent written and verbal communication skills.
BENEFITS
Competitive compensation package with base salary $274,000–$330,000/year.
Annual performance bonus and equity.
401(k) with employer contributions.
Generous stock options and ESPP.
20 days of paid time off at hire, additional holidays.
Health, dental, vision, and life insurance with substantial employer match.
Paid parental leave.
In‑office catered lunches, Home Office Setup, lifestyle stipend, commuter stipend (Boston).
Team social activities and wellness events.
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 identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.
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Join a team committed to making a meaningful impact on cancer treatment through the discovery and development of precision medicines. A leading biopharmaceutical organization focused on patient‑centric, precision‑medicine therapeutics seeks an innovative, passionate professional to join our vision.
ESSENTIAL JOB FUNCTIONS The Senior Director of Pharmacovigilance provides strategic and operational leadership for global safety surveillance across Kura’s clinical and post‑marketing programs. Responsibilities include signal detection and evaluation, benefit‑risk assessment, safety surveillance strategies, and compliance with global pharmacovigilance regulations.
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 such as Safety Monitoring Committees.
Safety Surveillance & Signal Management
Develop and evolve safety signal detection methodologies and product‑specific signaling strategies.
Lead signal validation, prioritization, and assessment processes in line with global regulations; interpret safety signals and trends and communicate safety assessments (written and verbal) with stakeholders.
Provide strategic oversight for Risk Management Plans (RMPs), REMS (where 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, etc.).
Ensure alignment of safety messaging across clinical, regulatory, and medical communications.
Provide strategic direction of safety content for key regulatory documents 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.
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.
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
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.
Proficient data‑analysis/visualization skills and familiarity with MedDRA/WHODrug dictionaries.
Proven experience authoring and reviewing aggregate safety reports.
Deep understanding of current global PV regulations (FDA, EMA, CIOMS, ICH E2 guidelines).
Strategic thinker, self‑starter with strong scientific judgment.
Executive presence and ability to influence cross‑functional stakeholders.
Excellent written and verbal communication skills.
BENEFITS
Competitive compensation package with base salary $274,000–$330,000/year.
Annual performance bonus and equity.
401(k) with employer contributions.
Generous stock options and ESPP.
20 days of paid time off at hire, additional holidays.
Health, dental, vision, and life insurance with substantial employer match.
Paid parental leave.
In‑office catered lunches, Home Office Setup, lifestyle stipend, commuter stipend (Boston).
Team social activities and wellness events.
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 identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.
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