Associate Director, Clinical Safety & PV (Hybrid/Remote)

Sironax; Waltham (MA); Hybride; USD 180 000 - 240 000; Plein temps

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

Clinical judgment

Communication with physicians

Influencing decisions

Formation

RN, NP, or PharmD qualification

Description du poste

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