Director, Pharmacovigilance Scientist

About Us 

Position Title: Director, PV Scientist

Department: Pharmacovigilance

Reports To: Head of Pharmacovigilance

Location: Princeton, NJ – On-site 4 days per week (Mon to Thurs)

About Us

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.

At Kardigan, we are motivated by our values which guide how we work, interact, and achieve our goals. Driven by patients and their families, we are deeply committed to improving the lives of patients and prioritizing their needs above all else. We believe in being authentic—leading with truth to bring out the best in others by creating an environment where every person knows they will be fully accepted. With an eagerness to learn, we encourage the highest levels of curiosity and are open to changing our minds. We are committed to winning as a team with urgency, excellence, and intention, and support each other no matter what role we play or where we sit. Lastly, we strive to enable the impossible because patients are counting on us. We are not afraid to take risks to unlock innovation and advance scientific discoveries.  

These values are the foundation of our work, empowering us to make a real difference, every day. 

Job Overview

The Director, PV Scientist, will be part of the Kardigan PV department, where they will be 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. Monitors and analyzes data from various sources, including clinical trials, post-marketing experience, medical and scientific literature and real-world evidence, to detect signals that indicate possible adverse reactions. Supports risk management strategy development for potential and identified risks associated with a Company product; creates risk management plan and supports risk management activities.  Writes aggregate safety reports. In addition, this position is responsible for building and maintaining relationships with key strategic internal and external stakeholders including PV Business Partners/Vendors and adverse event reporting/PV training of company personnel and their partners.

Essential Duties and Responsibilities

• Risk Management and Minimization: For assigned asset(s), lead the development of risk management activities, including strategy planning, risk management plan execution. Writes the company core risk management plan and REMS, as required.
• Signal Detection/Management: Leads signal detection, validation, analysis and prioritization, assessment and recommendation of action activities for assigned asset(s) for the continuous benefit-risk evaluation throughout the product lifecycle. Contributes/leads preparation for escalation to company safety governance committees.
• Safety Analysis Reporting: Collaborates with/Leads the preparation of safety analysis reports and visualizations to communicate key insights.
• Safety Documentation Management: For one or more assets, coordinates with PV Physicians and other stakeholders the creation and management of relevant safety/benefit-risk management strategy sections of clinical trial protocols, Investigator's Brochure (IB) (including the reference safety information section), 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 labelling, as necessary.
• ICSR Safety Review: Coordinate the individual case safety review of Adverse Event reports for Kardigan products either within or external to the safety database throughout the lifecycle of the product for impact to the benefit-risk profile. Additionally, performs aggregate data safety review and the review of relevant scientific literature articles for assigned asset(s).
• Ongoing Safety Oversight: For assigned asset(s), serve as a member of the PV safety governance teams for the evaluating of benefit-risk changes and the impact to company safety strategy and risk management activities.
• Regulatory Documentation Support: Supports the implementation of safety risk management, risk communication and signal management decisions into key regulatory document sections regulatory filings, New Drug Applications (NDAs), and responses to safety queries from third-parties, such as regulatory agencies.
• Audit and Inspection Support: Function as the PV representative for Health Authority Inspections, third-party audits and Internal Process Audits within the remit of role and responsibility.
• SOP and Quality Documentation Management: Leads the drafting, reviewing and maintaining PV department SOPs, work instructions and related materials such as training documentation within the remit of role and responsibility.
• Third-party Oversight: Support the oversight of vendors supporting company PV operations throughout the engagement including contributing to due diligence, pharmacovigilance agreements, ongoing monitoring and issue escalation.
• Support PV and IT Process Improvements: Function as the SME for PV QMS enhancements.  Additionally, serve as the PV SME to ensure supporting IT applications and analytical tools are configured and maintained to support the business needs and facilitates accurate reporting and analytics.
• Stakeholder support: Works closely with PV Physicians to develop and maintain relationships across the company particularly in functions such as clinical development/operations, clinical data management, clinical supply, manufacturing, commercial, regulatory affairs, quality, vendor/external contracts/finance, medical affairs, and other functions as appropriate to ensure compliance with PV risk management measures and ensure an integrated PV system.
• Staff/Team Management: Initially functioning as an individual contributor, role may develop into managing of direct reports. May be responsible for managing internal and external staff allocated to operational PV activities, creating a highly efficient team across insourced and outsourced resources.
• You will champion excellence in drug safety and PV practices throughout the company. Responsible for staying up-to-date with the latest advancements in signal processing and data analysis techniques.
• Provides expert guidance and leadership both internally and externally 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).
• Represents 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 role in pharmaceutical industry; managerial role in drug safety preferred; experience in biopharmaceuticals 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 a strong analytical mindset.
• Strong knowledge and experience with currently available drug safety database systems, document management systems and QC tools. This also includes MedDRA and linked technologies.
• Operational expertise with Safety database is preferred.
• Excellent oral and written communication skills
• Strong interpersonal and leadership skills and demonstrated ability to manage, motivate and influence work behaviors of individuals who are not direct reports
• Must thrive working in a fast growing/evolving, innovative environment while remaining flexible, proactive, resourceful and efficient.
• Excellent interpersonal skills, ability to develop important relationships with key stakeholders, good conflict management and negotiation skills, ability to analyze complex issues to develop relevant and realistic plans, programs and recommendations. 
• Demonstrated ability to translate strategy into action; excellent analytical skills and an ability to communicate complex issues in a simple way and to orchestrate plans to resolve issues and mitigate risks.