Kriya Therapeutics, Inc.
Senior Director, Pharmacovigilance
The Senior Director, Pharmacovigilance leads the pharmacovigilance function to ensure the safety of investigational and marketed gene therapy products. This role involves designing and executing safety surveillance programs, clinical evaluation of adverse events, regulatory compliance, and integrating safety 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.
Required
- • MD or PhD in a relevant discipline; or an equivalent combination of education & experience.
- • 12+ years of experience in pharmacovigilance or a related field.
- • In-depth knowledge of pharmacovigilance regulations and guidelines.
- • 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.
Preferred
- • Gene therapy experience in a biotech/pharmaceutical company preferred.
- • Foster a culture of accountability, scientific rigor, and continuous improvement.
Benefits & Perks
- • Flexible Time Off
- • Paid Parental & Medical Leave
- • Paid Company Holidays
- • Fertility & Family Building Benefits
- • Medical, Dental, and Vision Insurance
- • Employee Assistance Program (EAP)
- • Life Insurance
- • Short- and Long-Term Disability Coverage
- • Equity
- • 401(k) with Company Match
- • Identity Theft Protection
- • And More!
Department: Clinical
Employment Type: Full Time
Location: Research Triangle Park, NC
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
Experience & Skills and Work Environment
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
Employment Type: Full Time
Location: Research Triangle Park, NC
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
- 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.
- Primarily desk-based, generally in an office or home office setting.
- Involves extended periods of sitting and computer use.
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!
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