Director, Pharmacovigilance Scientist

The posting, as Kardigan wrote it

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 sta
[…]
iodic Adverse Drug Experience Report (PADER).

• Working knowledge of global pharmacovigilance regulations and guidance, including FDA and EMA requirements, International Council for Harmonisation (ICH) guidelines, and Good Pharmacovigilance Practice (GVP).

Preferred Qualifications

• Advanced degree in a life sciences discipline (MS, PharmD, PhD), or an MBA.
• Experience in biopharmaceuticals or a clinical-stage biotechnology environment.
• Managerial experience in drug safety, or experience overseeing outsourced pharmacovigilance resources and vendors.
• Experience authoring an EU Risk Management Plan (RMP) or a Risk Evaluation and Mitigation Strategy (REMS).
• Experience supporting health authority inspections or pharmacovigilance audits.
• Cardiovascular therapeutic area experience.
• Excellent oral and written communication and collaboration skills with demonstrated ability to communicate complex safety issues simply and to influence cross-functional partners and governance committees who are not direct reports.
• Knowledge of statistical modeling and machine learning algorithms.
• Knowledge of advanced analytics, digital health technologies, artificial intelligence, machine learning, real world evidence analysis, or automation technologies applicable to signal detection, aggregate reporting, safety surveillance, and benefit-risk assessment.
• Hands-on experience using a drug safety database systems, electronic data capture, document management systems, and quality control tools, including the Medical Dictionary for Regulatory Activities (MedDRA).
• Attention to detail and a strong analytical mindset, with demonstrated ability to translate strategy into action and to communicate complex issues in a simple way.
• Ability to thrive in a fast-growing, evolving, innovative environment while remaining flexible, proactive, resourceful, and efficient.

Exact Compensation may vary based on skills, experience and location.

Pay range
$204,000 — $250,000 USD