Senior Director, Preclinical Toxicology

5AM Ventures; Emeryville (CA); Presencial; USD 220.000 - 250.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical, dental & vision

401(k) with match

Equity option

Paid time off

Descripción de la vacante

Prolynx in Emeryville seeks an experienced leader to build and direct nonclinical safety strategy for ultra-long-acting therapeutics. You will lead GLP/non-GLP toxicology, manage a global CRO network, and author regulatory documents while aligning with senior leadership.

As a member of the Preclinical Leadership Team, you will shape program strategy, resourcing, and regulatory interactions with FDA and other authorities. A PhD and 10+ years of toxicology are required.

Formación

• PhD/DVM or equivalent in toxicology, pharmacology or related field.
• 10+ years of toxicology experience in biotech or pharma.
• Leads nonclinical safety strategy for programs through clinic.
• Experience managing international CROs with budgets.
• Regulatory submissions experience (IND/IMPD) and health authority interactions.

Responsabilidades

• Define stage-specific safety data needs and go/no-go recommendations.
• Design, oversee and interpret GLP and non-GLP toxicology studies at CROs.
• Lead safety assessment of the delivery platform and payload toxicology.
• Manage a global CRO network, including selection and budgeting.
• Author nonclinical sections of regulatory submissions and interact with agencies.
• Lead preclinical project teams and contribute to program strategy.

Conocimientos

Toxicology leadership

GLP study design

Regulatory interactions

CRO management

Strategic thinking

Cross-functional leadership

Educación

PhD in toxicology or related

Descripción del empleo

Prolynx in Emeryville seeks an experienced leader to build and direct nonclinical safety strategy for ultra-long-acting therapeutics. You will lead GLP/non-GLP toxicology, manage a global CRO network, and author regulatory documents while aligning with senior leadership.

As a member of the Preclinical Leadership Team, you will shape program strategy, resourcing, and regulatory interactions with FDA and other authorities. A PhD and 10+ years of toxicology are required.