Oversees and directs the activities of the Toxicology group. Provides strategic and operational direction ensuring that toxicology studies are conducted in line with the appropriate guidelines and regulatory test standards (FDA, WHO, GLP, and ISO). Oversees and evaluates protocol preparation for toxicology studies. Ensures that all safety testing plans, registration activities, government submissions, and design control activities are addressed in accordance with Research and Development requirements. Responsible for in-life resource planning, maintaining current testing procedures, program development, performance monitoring, budget planning and resource management.

Essential Functions

·         Provides leadership, mentorship, and oversight to the Toxicology function in their conduct of all nonclinical safety assessments for Company’s discovery and development compounds

·         Drives the strategic vision and direction of the Toxicology function at Company to enable development of world-class capabilities in support of numerous small molecule and biologic modalities

·         Works in collaboration with other Research and Development Team members and with Company leadership to ensure safety pharmacology and toxicology support is provided to ensure provision of requisite data in a timely manner to meet development goals.

·         Critically evaluate toxicology results and provides timely strategic advice to project teams and senior management on the potential impact of toxicology results on Program and Clinical/Regulatory strategy

·         Oversee and provide direction in the preparation of Safety Pharmacology and Toxicology sections of regulatory documents (IND, CTA, NDA, briefing books, Investigator Brochures, etc.)

·         Represent Preclinical Development on discovery and development-stage program teams

·         Develops critical insights from data summaries and shapes presentations of results to peers, colleagues and Company Management.

·         Oversees the adherence to all SOPs for Toxicology.

·         Proactively research and stay current on all applicable regulatory guidances

·         Other duties as assigned

Knowledge and Qualifications

·         Common Knowledge & Skills:

·         Acts as a "trusted advisor" across the company and may be recognized as an external expert

·         Provides strategy, vision and direction regarding issues that may have company-wide impact

·         Requires in-depth knowledge of the functional area, business strategies, and the company’s goals

·         Possesses industry-leading knowledge of Toxicology assessment of small molecules and biologics

·         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.

·         Job Specific Knowledge & Qualifications:

·         Extensive knowledge of toxicologic pathology is beneficial

·         Extensive knowledge of managing clinical Contract Research Organizations (CRO's)

·         Demonstrated involvement in the of preparation of INDs, CTAs, NDAs, and MAAs

·         Maintains broad knowledge of scientific principles and theories and possesses intellectual mastery of multiple scientific areas

Typical Experience or Education

Education

and

Experience

OR

PhD in Toxicology, Pathology or closely related discipline

and

12+ years of pharmaceutical/biotech experience, including managing clinical Contract Research Organizations. Experience in toxicologic pathology is beneficial

OR

D.V.M

and

8+ years of similar experience noted above

Extensive previous leadership experiences also required