Director/Senior Director, Preclinical Program Leadership

Evozyne; United States; Sur place; USD 180 000 - 240 000; Plein temps

Résumé du poste

Scorpion Therapeutics is seeking a Lead for preclinical program operations, driving candidate nomination through IND clearance for biologics and protein therapeutics in an AI-driven biotech setting. The role demands overseeing cross-functional workflows, budgets, and external collaborations in a remote setup.

The ideal leader will possess an advanced degree (PhD preferred) with 8+ years (or 12+ years for MS) of industry experience, a proven track record managing IND programs with CRO/CDMO

Qualifications

• Advanced degree in biochemistry, pharmacology, toxicology, or related field.
• 8+ years (Ph.D.) or 12+ years (Master's) industry experience.
• Proven success managing multiple IND programs with CRO/CDMO vendors.
• Deep understanding of drug development, GxP, ICH, and FDA preclinical guidelines.
• Strong stakeholder influence skills.

Responsabilités

• Manage cross-functional workflows, timelines, budgets, and dependencies;
• Oversee external CRO/CDMO collaborations;
• Develop and maintain integrated development plans;
• Design and review study protocols;
• Establish scalable operational processes.

Connaissances

IND program management

CRO/CDMO management

GxP/ICH/FDA preclinical knowledge

Stakeholder influence

Cross-functional collaboration

Formation

PhD in Biochemistry/Pharmacology/Toxicology

MS in related field

Description du poste

Role

Lead preclinical program operations from candidate nomination through IND clearance for biologics, including protein therapeutics, in an AI-driven biotech setting.

Responsibilities

• manage cross-functional workflows, timelines, budgets, and dependencies;
• oversee external CRO/CDMO collaborations;
• develop and maintain integrated development plans;
• design and review study protocols;
• and establish scalable operational processes.

Requirements

• advanced degree in biochemistry, pharmacology, toxicology, or related field;
• 8+ years (Ph.D.) or 12+ years (Master's) industry experience;
• proven success managing multiple IND programs with CRO/CDMO vendors;
• deep understanding of drug development, GxP, ICH, and FDA preclinical guidelines;
• strong stakeholder influence skills.

Preferred

• experience in biologics and protein therapeutics;
• strategic and operational judgment;
• excellent communication and organizational skills;
• comfort in fast-paced, evolving environments.

High-Value

• biologics
• protein therapeutics
• IND enabling
• CRO/CDMO management
• GxP
• ICH
• FDA preclinical requirements

WorkSetup

remote.