Kardigan
Kardigan is a heart health company working to make cardiovascular disease preventable, curable and no longer the leading cause of death in the world. It is Kardigan’s mission to develop multiple targeted treatments in parallel that bring people with cardiovascular diseases to the cures they deserve. Led by Tassos Giannakakos, Jay Edelberg, M.D. and Bob McDowell, Ph.D., Kardigan’s co‑founders have reunited after leading MyoKardia to discover and develop mavacamten, the first cardiac myosin inhibitor, resulting in an acquisition by Bristol Myers Squibb in 2020. We have a cutting‑edge discovery and translational research platform, a pipeline of late‑stage candidates, and an industry‑leading team that is driven to improve the lives of patients.
Position Title Director, PV Scientist
Reports To Head of Pharmacovigilance
Location Princeton, NJ – On‑site 4 days per week (Mon to Thurs)
Job Overview The Director, PV Scientist will be part of the Kardigan PV department, responsible for the development, management, execution, and oversight of all aspects of the patient safety benefit‑risk program for one or more company asset(s) throughout the product(s’) life cycle from development through marketing. This individual plays a key role in leading the process that supports identifying and managing potential safety concerns related to the Company’s products, identifying and implementing safety surveillance and analytical tools, monitoring and analyzing data from various sources to detect signals that indicate possible adverse reactions, and supporting risk management strategy development.
Essential Duties and Responsibilities
Risk Management and Minimization : Lead the development of risk management activities, including strategy planning and risk management plan execution. Write company core risk management plan and REMS, as required.
Signal Detection/Management : Lead signal detection, validation, analysis and prioritization, assessment and recommendation of action activities for assigned asset(s); contribute/leads preparation for escalation to company safety governance committees.
Safety Analysis Reporting : Collaborate with or lead the preparation of safety analysis reports and visualizations to communicate key insights.
Safety Documentation Management : Coordinate with PV Physicians and stakeholders for the creation and management of safety/benefit‑risk management strategy sections of clinical trial protocols, Investigator’s Brochure (IB), informed consent form (ICF), safety management plan (SMP), clinical study reports (CSR), Aggregate Safety Reports, risk management plan (RMP), Company Core Safety Information, and other labeling, as necessary.
ICSR Safety Review : Coordinate individual case safety review of adverse event reports within or external to the safety database; perform aggregate data safety review and review of relevant scientific literature articles for assigned asset(s).
Ongoing Safety Oversight : Serve as a member of the PV safety governance teams for evaluating benefit‑risk changes and their impact on company safety strategy.
Regulatory Documentation Support : Support implementation of safety risk management, risk communication and signal management decisions into regulatory filings (NDAs) and responses to safety queries from regulatory agencies.
Audit and Inspection Support : Function as the PV representative for Health Authority inspections, third‑party audits and internal process audits.
SOP and Quality Documentation Management : Lead drafting, reviewing and maintaining PV department SOPs, work instructions and related materials such as training documentation.
Third‑Party Oversight : Support oversight of vendors supporting company PV operations, including due diligence, pharmacovigilance agreements, ongoing monitoring and issue escalation.
Process Improvements : Serve as SME for PV QMS enhancements; ensure supporting IT applications and analytical tools are configured and maintained to support business needs.
Stakeholder Support : Work closely with PV Physicians to maintain relationships across the company, ensuring compliance with PV risk management measures.
Staff/Team Management : Initially an individual contributor; may develop into managing direct reports and other operational PV staff.
Champion excellence in drug safety and PV practices throughout the company; stay up‑to‑date with signal processing and data analysis techniques.
Provide expert guidance and leadership based on in‑depth knowledge of development and post‑marketing safety requirements, per ICH, US and international regulations and guidelines, and Good Pharmacovigilance Practice (GVP).
Represent PV on project teams, other departments, and committees as needed.
Qualifications and Preferred Skills
Bachelor’s degree in life sciences, pharmacy, nursing or equivalent health experience; advanced life sciences degree or MBA preferred.
Minimum of 8‑10 years of experience in drug safety / pharmacovigilance; managerial role preferred; biopharmaceutical experience preferred.
Proven experience in signal detection and data analysis of data from various sources.
Proficiency in data analysis tools.
Experience in scientific writing.
Thorough understanding of pharmacovigilance regulations.
Strong knowledge of statistical modeling and machine learning algorithms preferred.
Excellent communication and collaboration skills.
Attention to detail and strong analytical mindset.
Strong knowledge and experience with drug safety database systems, document management systems and QC tools; includes MedDRA and linked technologies.
Operational expertise with safety database preferred.
Excellent oral and written communication skills.
Strong interpersonal and leadership skills; demonstrated ability to manage, motivate, and influence work behaviors of individuals who are not direct reports.
Thrives in a fast‑growing, innovative environment while remaining flexible, proactive, resourceful, and efficient.
Excellent interpersonal skills; ability to develop relationships with key stakeholders and manage conflict and negotiation.
Demonstrated ability to translate strategy into action and communicate complex issues simply.
Compensation Exact compensation may vary based on skills, experience and location.
Pay range: $209,000 – $272,000 USD
Equal Employment Opportunity Statement As set forth in Kardigan’s Equal Employment Opportunity policy, we do not discriminate on the basis of any protected group status under any applicable law. If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA.
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Position Title Director, PV Scientist
Reports To Head of Pharmacovigilance
Location Princeton, NJ – On‑site 4 days per week (Mon to Thurs)
Job Overview The Director, PV Scientist will be part of the Kardigan PV department, responsible for the development, management, execution, and oversight of all aspects of the patient safety benefit‑risk program for one or more company asset(s) throughout the product(s’) life cycle from development through marketing. This individual plays a key role in leading the process that supports identifying and managing potential safety concerns related to the Company’s products, identifying and implementing safety surveillance and analytical tools, monitoring and analyzing data from various sources to detect signals that indicate possible adverse reactions, and supporting risk management strategy development.
Essential Duties and Responsibilities
Risk Management and Minimization : Lead the development of risk management activities, including strategy planning and risk management plan execution. Write company core risk management plan and REMS, as required.
Signal Detection/Management : Lead signal detection, validation, analysis and prioritization, assessment and recommendation of action activities for assigned asset(s); contribute/leads preparation for escalation to company safety governance committees.
Safety Analysis Reporting : Collaborate with or lead the preparation of safety analysis reports and visualizations to communicate key insights.
Safety Documentation Management : Coordinate with PV Physicians and stakeholders for the creation and management of safety/benefit‑risk management strategy sections of clinical trial protocols, Investigator’s Brochure (IB), informed consent form (ICF), safety management plan (SMP), clinical study reports (CSR), Aggregate Safety Reports, risk management plan (RMP), Company Core Safety Information, and other labeling, as necessary.
ICSR Safety Review : Coordinate individual case safety review of adverse event reports within or external to the safety database; perform aggregate data safety review and review of relevant scientific literature articles for assigned asset(s).
Ongoing Safety Oversight : Serve as a member of the PV safety governance teams for evaluating benefit‑risk changes and their impact on company safety strategy.
Regulatory Documentation Support : Support implementation of safety risk management, risk communication and signal management decisions into regulatory filings (NDAs) and responses to safety queries from regulatory agencies.
Audit and Inspection Support : Function as the PV representative for Health Authority inspections, third‑party audits and internal process audits.
SOP and Quality Documentation Management : Lead drafting, reviewing and maintaining PV department SOPs, work instructions and related materials such as training documentation.
Third‑Party Oversight : Support oversight of vendors supporting company PV operations, including due diligence, pharmacovigilance agreements, ongoing monitoring and issue escalation.
Process Improvements : Serve as SME for PV QMS enhancements; ensure supporting IT applications and analytical tools are configured and maintained to support business needs.
Stakeholder Support : Work closely with PV Physicians to maintain relationships across the company, ensuring compliance with PV risk management measures.
Staff/Team Management : Initially an individual contributor; may develop into managing direct reports and other operational PV staff.
Champion excellence in drug safety and PV practices throughout the company; stay up‑to‑date with signal processing and data analysis techniques.
Provide expert guidance and leadership based on in‑depth knowledge of development and post‑marketing safety requirements, per ICH, US and international regulations and guidelines, and Good Pharmacovigilance Practice (GVP).
Represent PV on project teams, other departments, and committees as needed.
Qualifications and Preferred Skills
Bachelor’s degree in life sciences, pharmacy, nursing or equivalent health experience; advanced life sciences degree or MBA preferred.
Minimum of 8‑10 years of experience in drug safety / pharmacovigilance; managerial role preferred; biopharmaceutical experience preferred.
Proven experience in signal detection and data analysis of data from various sources.
Proficiency in data analysis tools.
Experience in scientific writing.
Thorough understanding of pharmacovigilance regulations.
Strong knowledge of statistical modeling and machine learning algorithms preferred.
Excellent communication and collaboration skills.
Attention to detail and strong analytical mindset.
Strong knowledge and experience with drug safety database systems, document management systems and QC tools; includes MedDRA and linked technologies.
Operational expertise with safety database preferred.
Excellent oral and written communication skills.
Strong interpersonal and leadership skills; demonstrated ability to manage, motivate, and influence work behaviors of individuals who are not direct reports.
Thrives in a fast‑growing, innovative environment while remaining flexible, proactive, resourceful, and efficient.
Excellent interpersonal skills; ability to develop relationships with key stakeholders and manage conflict and negotiation.
Demonstrated ability to translate strategy into action and communicate complex issues simply.
Compensation Exact compensation may vary based on skills, experience and location.
Pay range: $209,000 – $272,000 USD
Equal Employment Opportunity Statement As set forth in Kardigan’s Equal Employment Opportunity policy, we do not discriminate on the basis of any protected group status under any applicable law. If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA.
#J-18808-Ljbffr