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Senior Director, Pharmacovigilance

Kriya Therapeutics

Morrisville, North Carolina

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JOB DETAILS
SKILLS
Adverse Events, Analysis Skills, Biology, Biotech and Pharmaceutical, Clinical Assessment, Clinical Data, Clinical Practices/Protocols, Clinical Trial, Communication Skills, Continuous Improvement, Corrective Action, Cross-Functional, Database Administration, Database Management Software/Systems (DBMS), Detail Oriented, Disease, Drug Development, FDA (Food and Drug Administration), Gene Therapy, ICH Regulations, Interpersonal Skills, Leadership, Maintain Compliance, Management Strategy, Manufacturing, Marketing, Medical Writing, Metabolic Disorders, Neurology, Ophthalmology, Organizational Skills, Patient Safety, Pharmacovigilance, Problem Solving Skills, Product Marketing, Program Evaluation, Quality Assurance, Regulations, Regulatory Compliance, Regulatory Requirements, Risk Management, Safety Compliance, Safety/Work Safety, Startup, Surveillance, Team Player
LOCATION
Morrisville, North Carolina
POSTED
30+ days ago

Description


Kriya is a biopharmaceutical company whose mission is to develop life-changing gene therapies for diseases affecting millions of patients around the world.

We leverage our proprietary computational engine, in-house manufacturing infrastructure, and integrated design platform to engineer technologies and therapeutics with the potential to transform the treatment of a broad universe of diseases of high unmet need, with a focus on metabolic disorders, neurology, and ophthalmology.

We are proud to have been named Triangle Business Journal’s Life Sciences 2024 “Best Private Company to Work For,” recognized by Forbes as one of “America’s Best Startup Employers of 2024,” and honored as one of BioSpace’s “2025 Best Places to Work.”

Role Overview


The Senior Director, Pharmacovigilance is responsible for leading Kriya's pharmacovigilance function and ensuring the safety of investigational and/or marketed gene therapy products. This role oversees the design and execution of safety surveillance programs, clinical evaluation of adverse events, and ensures regulatory compliance. The Senior Director integrates safety considerations into program strategy.

Key Responsibilities
  • Design and execute pharmacovigilance and safety strategies across Kriya’s asset portfolio, ensuring alignment with regulatory requirements and corporate objectives.
  • Establish and oversee processes for clinical evaluation of adverse event (AE) reports, including causality assessment, severity classification, and maintenance of the PV database.
  • Ensure quality and compliance of safety narratives, case reports, and aggregate reports; develop and oversee implementation of risk management and mitigation plans.
  • Lead interactions with regulatory authorities on safety-related matters; oversee preparation and submission of periodic safety update reports (PSURs) and other required regulatory documents in compliance with FDA, EMA, ICH, and other applicable regulations.
  • Monitor safety profiles of products through post-marketing surveillance and clinical trials; track external safety data from regulators and comparable programs to inform Kriya’s decisions.
  • Collaborate with cross-functional teams, including clinical, regulatory, CMC and quality assurance to integrate safety into program strategy and ensure completion of corrective and preventative actions (CAPAs).
  • Contribute to risk management strategies at all stages of development and commercialization.

Experience & Skills and Work Environment


Experience & Skills
  • MD or PhD in a relevant discipline; or an equivalent combination of education & experience.
  • 12+ years of experience in pharmacovigilance or a related field.
  • Gene therapy experience in a biotech/pharmaceutical company preferred.
  • In-depth knowledge of pharmacovigilance regulations and guidelines.
  •  Foster a culture of accountability, scientific rigor, and continuous improvement.
  • Strong analytical and problem-solving skills.
  • Excellent communication and interpersonal skills.
  • Proficiency in pharmacovigilance databases and software. 
  • Ability to critically evaluate clinical data.
  •  Strong understanding of drug development and lifecycle management.
  • Detail-oriented with strong organizational skills.
  • Ability to work independently and as part of a team.
  •  Proficiency in medical writing and documentation.
  • Strong ethical standards and commitment to patient safety. 

Work Environment
  • Primarily desk-based, generally in an office or home office setting.
  • Involves extended periods of sitting and computer use.

Life at Kriya


Discover True Collaborative Teamwork
We have an ambitious set of goals, but our confidence – and our inspiration – stems from our people. From California to North Carolina, our teammates bring a spirit of Collaboration, Leadership, and Innovation to their work every day.

We’re always looking for teammates with the drive and energy to help us grow. If you want to be a part of a company with an entrepreneurial culture, a bold vision, and a meaningful purpose, join us.

Rewards & Benefits
  • Time Off & Work-Life Balance: Flexible Time Off Paid Parental & Medical Leave Paid Company Holidays
  • Health & Wellness:  Fertility & Family Building Benefits Medical, Dental, and Vision Insurance Employee Assistance Program (EAP) Life Insurance Short- and Long-Term Disability Coverage
  • Financial Security:Equity 401(k) with Company Match Identity Theft Protection
  • And More!

About the Company

K

Kriya Therapeutics

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