Director, PV Scientist

Kardigan•Princeton, NJ

3d•$204,000 - $250,000•Hybrid

About The Position

Kardigan is hiring a Director, PV Scientist for its Pharmacovigilance Department. Based in Princeton, New Jersey, the position is hybrid, with on-site work four days per week (Monday through Thursday), and requires up to 5% travel. The role reports to the VP, Head of Pharmacovigilance. The Director will serve as the safety lead for one or more cardiovascular assets, supporting product safety, risk management, and benefit-risk assessment from first-in-human studies through commercialization. The role includes signal detection and assessment; authoring safety and risk-management documents; reviewing individual case and aggregate safety data; supporting regulatory submissions, audits, and inspections; and overseeing pharmacovigilance vendors and quality processes. The position will also help select and implement safety surveillance and analytical tools and advance technology-enabled, data-driven pharmacovigilance processes. Initially an individual-contributor role, it may develop to include direct reports and responsibility for internal and external staff. The Director will work across functions and represent pharmacovigilance on project teams and committees. Kardigan describes its mission as developing targeted cardiovascular treatments and emphasizes patient focus, authenticity, curiosity, teamwork, urgency, excellence, and innovation. The stated pay range is $204,000–$250,000 USD; exact compensation may vary based on skills, experience, and location.

Requirements

Bachelor’s degree in life sciences, pharmacy, nursing, or an equivalent health-related discipline.
At least 8 years of drug safety or pharmacovigilance experience in the pharmaceutical or biotechnology industry.
Experience performing signal detection and safety surveillance using clinical-trial, post-marketing, and scientific-literature data.
Scientific-writing experience, including authoring or leading aggregate safety reports such as DSURs, PBRERs, or PADERs.
Working knowledge of global pharmacovigilance regulations and guidance, including FDA and EMA requirements, ICH guidelines, and GVP.

Nice To Haves

Advanced degree in a life sciences discipline (MS, PharmD, or 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.
Experience in the cardiovascular therapeutic area.
Excellent oral and written communication and collaboration skills, including the ability to explain complex safety issues simply and 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 applicable to signal detection, aggregate reporting, safety surveillance, and benefit-risk assessment.
Hands-on experience with drug safety database systems, electronic data capture, document management systems, and quality-control tools, including MedDRA.
Attention to detail, a strong analytical mindset, ability to translate strategy into action, and ability to communicate complex issues simply.
Ability to thrive in a fast-growing, evolving, innovative environment while remaining flexible, proactive, resourceful, and efficient.

Responsibilities

Serve as safety lead for one or more cardiovascular assets across the product lifecycle, supporting product safety, risk management, and benefit-risk assessment.
Support risk-management strategy and plan execution; author the Company core risk management plan, EU Risk Management Plan (RMP), and Risk Evaluation and Mitigation Strategy (REMS), as required.
Support signal detection, validation, analysis, prioritization, assessment, and action recommendations using clinical-trial, post-marketing, scientific-literature, and real-world evidence data; prepare escalations to safety governance committees.
Author aggregate safety reports and support safety analyses and data visualizations for governance committees, regulators, and cross-functional partners.
Coordinate creation and maintenance of safety and benefit-risk content for clinical protocols, Investigator’s Brochures, informed consent forms, safety management plans, clinical study reports, aggregate safety reports, risk management plans, Company Core Safety Information, and labeling.
Coordinate individual case safety review of adverse-event reports and conduct aggregate data safety reviews and relevant scientific-literature reviews for assigned assets.
Serve on pharmacovigilance safety governance teams evaluating benefit-risk changes and their impact on safety strategy and risk-management activities.
Translate safety risk-management, risk-communication, and signal-management decisions into regulatory documents and filings, including NDAs and responses to safety queries.
Represent pharmacovigilance during health authority inspections, third-party audits, and internal process audits within the role’s remit.
Draft, review, and maintain pharmacovigilance SOPs, work instructions, training documentation, and related materials.
Oversee pharmacovigilance vendors, including due diligence, pharmacovigilance agreements, ongoing monitoring, and issue escalation.
Serve as a subject matter expert for pharmacovigilance QMS enhancements; select and implement safety surveillance and analytical tools and help implement technology-enabled, data-driven improvements.
Collaborate with pharmacovigilance physicians and cross-functional stakeholders to support compliance with PV risk-management measures and an integrated pharmacovigilance system.
Initially work as an individual contributor, with the role potentially developing to include direct-report management and oversight of internal and external staff supporting operational PV activities.
Serve as an internal and external authority on development and post-marketing safety requirements, including ICH guidelines, US and international regulations, and GVP; keep the company current on advances in signal detection and safety data analysis.
Represent pharmacovigilance on project teams, in other departments, and on committees as needed.