Leading Bioscience company is expanding and looking for a strong Director of Toxicology to join their team. 

This role requires on-site presence in the San Diego office .FULL RELOCATION is offered.

Robust compensation package including base salary, bonus and other Long Term incentives.

Director, Toxicology

Responsible for overseeing the design, conduct, interpretation and reporting of Safety Pharmacology and Toxicology studies for assigned Discovery and Development programs. Liaise with Research and Development colleagues to develop overall Safety Pharmacology and Toxicology Development Strategies for assigned programs. Represent Preclinical Development on Discovery and Development teams and regularly interface with internal and external colleagues to ensure timely and accurate dissemination of Safety Pharmacology and Toxicology findings._Your Contributions (include, But Are Not Limited To)

• Drives the strategic scientific direction for area of responsibility
• Lead the design, conduct, interpretation and reporting of Safety Pharmacology and Toxicology studies/data for assigned programs
• Manage preclinical Contract Research Organizations (CROs) for assigned programs
• Ensure timely completion of priority activities for assigned programs
• Critically evaluate toxicology results and provide strategic advice to project teams and senior management on the potential impact of toxicology results on Program and Clinical/Regulatory strategy
• Responsible for the preparation of Safety Pharmacology and Toxicology sections of regulatory documents (IND, CTA, NDA, briefing books, Investigator Brochures, periodic safety reports, etc.)
• Represent Preclinical Development on discovery and development-stage program teams
• Responsible for the preparation of pharmacology and toxicology summaries and presentations of results to peers, colleagues and Company Management.
• Contribute to the preparation of SOPs as needed to guide functional activities
• Be knowledgeable of current regulatory guidance (eg ICH, EMA, FDA) related to preclinical development
• May manage junior members of department
• Other tasks as assigned

Requirements

• PhD in Toxicology, Pathology or closely related discipline and 10+ years of pharmaceutical/biotech experience, including managing clinical Contract Research Organizations. Experience in toxicologic pathology is beneficial OR
• D.V.M. and 7+ years of similar experience noted above
• Previous managerial experience beneficial
• Excellent working knowledge of Good Laboratory Practices (GLP) regulations
• Extensive experience managing preclinical Contract Research Organizations (CROs)
• Experience with preparation of INDs, CTAs, NDAs, and MAAs
• Knowledge of toxicologic pathology is beneficial
• Experience with development of peptides and biologics including antibody based therapeutics and gene therapy
• Maintains broad knowledge of scientific principles and theories and possesses intellectual mastery of multiple scientific areas
• Recognized as an internal thought leader with extensive technical and business expertise within a strategic organization
• Applies in-depth knowledge of own function, business / commercial / scientific expertise to solve critical issues successfully and innovatively
• Evaluates key business / scientific challenges and completes complex, ambiguous initiatives having cross-functional impact
• Must be self-motivated, detail-oriented, decisive
• Ability to quickly learn and think independently
• Excellent interpersonal & communication skills with the ability to interact professionally and effectively with peers, management, and leadership both within and outside the Company
• Excellent managerial skills and experience fostering career development of direct and indirect reports

Demonstrated ability to influence and lead others