Head of Toxicology -- Direct Hire (Richmond, VA / Fort Collins, CO / Remote)
SRG is looking for a Head of Toxicology for a global pharmaceutical company that is working to change patients' lives by pioneering life-transforming treatment for serious mental illnesses. With a global portfolio in over 40 countries, they remain committed to discovering and developing new and effective treatments to help patients with a variety of diseases.
Serves as the company expert for the design and execution of pre-clinical toxicology assessments; sets the strategy and leads to its execution. Designs and conducts of preclinical (in vitro, PK/TK and toxicity in animals) studies, and responsible for interpretation and presentation of findings to support investigational new drug (IND), and new drug application (NDA) programs. Consistently brings preclinical projects to completion by efficiently managing preclinical toxicology function, recommending next steps as well as supporting the business objective of the company. Directly interacts with health authorities with regards to pre-clinical safety assessments of small molecules and biologics.
ESSENTIAL FUNCTIONS: The responsibilities of this job include, but are not limited to, the following:
- Clearly identifies and communicates drug product safety priorities, compliance strategy and contingency plans in collaboration with the management and project teams
- Responsible for preparation and ensures regulatory compliance of IND/NDA or MAA pre-clinical parts of submissions to the FDA and EMA
- Defends pre-clinical sections of submissions with regulatory authorities
- Designs, conducts and/or monitors (with assistance of the pre-clinical toxicologist) in-house and/or contracted in vitro or pharmacokinetic and toxicity animal studies to meet specific project team goals and regulatory requirements for IND and NDA submissions
- Accountable for all aspects of the conduct of pre-clinical studies, including protocol development, GLP and SOP compliance, interpretation of results, and writing and issuance of final reports
- Responsible for interdepartmental and interdisciplinary collaboration in acquisition and evaluation of study materials, coordination of all study activities, and interpretation and reporting of pre-clinical results
- Works as part of a multidisciplinary team to support the safety testing and compliance strategy
- Responsible for quality control checks on pre-clinical pharmacology, DMPK, and toxicology documents for regulatory submissions
- Responsible for the preparation and ensures regulatory compliance of annual investigational new drug and new drug application reports
- Builds and maintains technical databases, archives and department procedures manual
- Efficiently manages preclinical function by monitoring and evaluating completion of tasks and projects
- Manages and collaborates with external preclinical vendors, consultants, and partners
- Tracks and anticipates industry trends and maintains cutting edge understanding of best pre-clinical practices
- Actively participates in the development of best practices across the organization
Education: Ph.D. in a relevant field of study (e.g., toxicology, pharmacology) and Board Certification in toxicology (DABT) plus or minus DVM degree.
- 8+ years of pharmaceutical industry experience (including contract research organization work experience)
- Experience in preclinical support of small molecules and biologics programs
- Experience in direct interaction with heath authorities
- Excellent interpersonal and communication skills
- Demonstrated experience in technical writing
- Ability to lead projects and organize and guide the work of interdisciplinary team members
- Effective line and /or matrix management experience required
Travel: Study site monitoring and meeting with regulatory authorities as needed, professional conferences.
SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.