Associate Director / Director, Clinical Safety & Pharmacovigilance

Sironax; Waltham (MA); Hybrid; USD 180,000 - 240,000; Full time

Job summary

Sironax is seeking an experienced Associate Director / Director, Clinical Safety & Pharmacovigilance to shape safety across our global biotech pipeline. In this hands-on role you will lead clinical safety oversight across multiple programs, including first-in-human and early-phase trials, partnering with physicians and scientists to inform risk assessment and decision-making.

The ideal candidate has RN, NP, or PharmD credentials with 8–12+ years in clinical/pharma, plus 3+ years in

Qualifications

• RN, NP, or PharmD with 8+ years in clinical/pharma and 3+ years in trial pharmacovigilance.
• Strong clinical judgment with experience evaluating adverse events and laboratory findings.
• Experience overseeing CROs or outsourced pharmacovigilance providers.
• Knowledge of global safety reporting and regulatory expectations.
• Ability to work independently and influence cross-functional teams.

Responsibilities

• Lead clinical safety oversight across multiple investigational programs, including first-in-human, dose-escalation, and Phase 1/2 trials.
• Evaluate emerging safety data, identify potential safety signals, and inform clinical decisions with Development physicians.
• Collaborate with Translational Biology and Preclinical/Toxicology teams to align nonclinical findings with clinical safety monitoring.
• Contribute to protocols, safety monitoring plans, Investigator's Brochures, and dose-escalation reviews.
• Oversee global pharmacovigilance partners to ensure high-quality safety case management and regulatory compliance.
• Build scalable safety processes and governance for an expanding portfolio.
• Collaborate across regions (US, China, Australia) to support One Sironax culture.

Skills

Clinical judgment

Communication with physicians

Influencing decisions

Education

RN, NP, or PharmD qualification

Job description

Location: Waltham, MA (Hybrid) or remote

Help Shape Clinical Safety Across an Innovative Global Biotech Pipeline

At Sironax, we're advancing innovative therapies for patients with serious diseases and significant unmet medical needs. Our global team brings together scientific discovery, translational research, and clinical development to advance novel therapeutic programs.

We're looking for an experienced Associate Director / Director, Clinical Safety & Pharmacovigilance who brings strong clinical judgment, scientific curiosity, and a passion for patient safety.

This is not a traditional pharmacovigilance operations role. You'll have the opportunity to influence clinical development decisions, evaluate emerging safety findings, collaborate with scientists working on novel therapeutic mechanisms, and help shape how we approach clinical safety across our growing portfolio.

If you're an experienced RN, NP, or PharmD who enjoys connecting clinical science with practical drug development, we'd like to hear from you.

What You’ll Do

In this highly collaborative, hands-on role, you’ll:

• Lead clinical safety oversight across multiple investigational programs, including first-in-human, dose-escalation, and Phase 1/2 clinical trials.
• Evaluate emerging safety data, identify potential safety signals, and work with Clinical Development physicians to assess risks and inform clinical decisions.
• Connect clinical and translational science by partnering with Translational Biology and Preclinical/Toxicology teams to understand how nonclinical findings and emerging biomarkers may inform clinical safety monitoring.
• Help shape clinical development strategies through contributions to protocols, safety monitoring plans, Investigator's Brochures, dose-escalation reviews, and benefit-risk assessments.
• Oversee global pharmacovigilance partners, ensuring high-quality safety case management, reporting, and regulatory compliance.
• Build and strengthen our safety capabilities, helping develop scalable processes, governance practices, and effective cross-functional collaboration as our clinical portfolio advances.
• Collaborate globally with colleagues across the United States, China, Australia, and other regions, supporting our One Sironax culture.

What You’ll Bring

We're seeking a clinically grounded professional who can see beyond individual adverse event reports to understand the broader safety profile of an investigational therapy.

Required qualifications:

• RN, NP, or PharmD qualification with substantial clinical and pharmaceutical industry experience (~8+ years of relevant experience for Associate Director candidates or 10-12+ years for Director candidates, including at least 3 years of significant clinical trial pharmacovigilance experience).
• Strong clinical judgment and demonstrated experience evaluating adverse events, laboratory findings, and emerging safety signals.
• Experience supporting early-stage clinical development, preferably including first-in-human or dose-escalation studies.
• Experience overseeing CROs or outsourced pharmacovigilance providers.
• Working knowledge of global clinical safety reporting requirements and regulatory expectations.
• Ability to work independently, communicate effectively with physicians and scientists, and influence cross-functional decisions.

About Sironax

Sironax is a global clinical-stage biotechnology company focused on developing innovative therapies for neurodegenerative, inflammatory, immunologic, and rare diseases. Driven by scientific excellence and a patient-centered mission, Sironax is expanding its global presence to transform treatment paradigms and improve outcomes for patients worldwide.

Equal Opportunity Employer

Sironax is an equal opportunity employer committed to diversity, equity, and inclusion. We welcome applicants from all backgrounds and are dedicated to creating a work environment where everyone feels valued and empowered.