Director, PV Scientist

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 Gianakakos, Jay Edelberg, M.D., Ph.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.
About the Job
Job Title: Director, PV Scientist
Department: Pharmacovigilance
Reports to: VP, Head of Pharmacovigilance
Location: Princeton, NJ
Classification: Hybrid – On-site 4 days per week (Mon to Thurs)
Travel: Up to 5% travel required
About the Team
The Kardigan Pharmacovigilance Department is dedicated to ensuring the safe and effective use of the Company’s products by systematically monitoring, identifying, and evaluating adverse drug reactions and other medication-related risks. Through rigorous data collection, analysis, and collaboration with healthcare professionals and regulatory authorities, the department plays a vital role in safeguarding patient health and supporting the Company's commitment to the highest standards of drug safety and regulatory compliance. Working closely with colleagues across Clinical Development, Regulatory Affairs, Medical Affairs, Quality, Clinical Operations and Commercial functions, the team turns safety data into clear, evidence-based judgments about benefit and risk that shape how our programs are designed, communicated, and approved.
We are building a team where scientific rigor, sound judgment, and a practical, solutions-oriented mindset matter more than hierarchy. Team members have the opportunity to build the standards, systems, and technology-enabled ways of working that will support Kardigan's portfolio as it grows, and to see that work reflected directly in how patients living with cardiovascular disease are protected.
Main Responsibilities
Product Safety Leadership: Serve as the safety lead for one or more of Kardigan's cardiovascular assets, from first-in-human studies through commercialization, supporting product safety, risk management, and benefit-risk assessment across the product lifecycle.
Risk Management and Minimization: For assigned assets, supports risk management activities, including strategy planning and risk management plan execution. Author the Company core risk management plan, the EU Risk Management Plan (RMP), and the Risk Evaluation and Mitigation Strategy (REMS), as required.
Signal Detection and Management: Support signal detection, validation, analysis, prioritization, assessment, and recommendation of actions for assigned assets, using data from clinical trials, post-marketing experience, scientific literature, and real-world evidence to support continuous benefit-risk evaluation throughout the product lifecycle. Prepare escalations to Company safety governance committees.
Safety Analysis and Reporting: Author aggregate safety reports and support the preparation of safety analyses and data visualizations that make complex findings clear to safety governance committees, regulators, and cross-functional partners.
Safety Documentation Management: For one or more assets, coordinate with pharmacovigilance physicians and other stakeholders to create and maintain the safety and 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.