Remote Executive Director of Safety & Pharmacovigilance
About the Role
We are seeking a Remote Executive Director of Safety & Pharmacovigilance to join Kyverna Therapeutics, a pioneering biopharmaceutical company dedicated to transforming treatment for autoimmune diseases. As the Executive Director of Safety & Pharmacovigilance, you will be instrumental in shaping the global safety strategy for our innovative cell therapy pipeline. This role offers the unique opportunity to work remotely while leading a critical function within our organization.
What You'll Do
- Define and lead the global safety and pharmacovigilance strategy across all development stages.
- Serve as the safety subject-matter expert for cell therapy programs, addressing novel and emerging safety risks.
- Provide strategic safety input to clinical development plans, protocols, investigator brochures, and regulatory submissions.
- Act as a key member of cross-functional governance and program teams.
- Oversee all pharmacovigilance activities including case processing, signal detection, risk management, and aggregate reporting.
- Ensure compliant execution of ICSR reporting, DSURs, PBRERs/PSURs, SUSARs, and safety narratives.
- Lead safety surveillance activities and ongoing benefit-risk assessments.
- Review and approve safety data, medical assessments, and regulatory safety documents.
Requirements
- MD degree with 12+ years of experience in pharmacovigilance and drug safety, including at least 5 years in a leadership role.
- Direct experience supporting cell therapy, gene therapy, or other advanced modalities is strongly preferred.
- Experience in clinical-stage biotech; prior BLA/MAA and/or launch experience is a plus.
- Demonstrated success interacting with global regulatory agencies on safety matters.
- Strong knowledge of global pharmacovigilance regulations and safety standards.
- Excellent cross-functional leadership and communication skills.
- Proven ability to balance compliance, scientific rigor, and business priorities.
Nice to Have
- Experience in a lean, fast-moving biotech environment.
- Strategic thinker with hands-on operational capabilities.
- Prior experience in managing external vendors and CROs.
What We Offer
- Competitive salary range of $365K-$390K annually.
- Bonus eligibility and comprehensive benefits package.
- Participation in the company’s stock plan.
- Flexible remote work environment.
- Opportunity to lead and innovate in the field of cell therapy.
This role offers a unique opportunity to lead safety and pharmacovigilance in a cutting-edge biotech company. With a competitive salary and remote work flexibility, it's an attractive position for experienced professionals.
Who Will Succeed Here
Deep expertise in pharmacovigilance processes and regulations, particularly in cell therapy, ensuring compliance with FDA and EMA guidelines.
Proven ability to lead cross-functional teams in a remote environment, utilizing tools like Slack and Asana to coordinate efforts between clinical, regulatory, and safety departments.
Strong analytical mindset with experience in risk management frameworks and clinical development strategies, capable of making data-driven decisions to enhance patient safety.
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