Director of Toxicology

Position Summary

The Director of Toxicology is responsible for the design, analysis, interpretation and reporting of in-vitro and in-vivo safety pharmacology and toxicology studies for AnaptyBio’s discovery and development programs. This will include exploratory and GLP studies to support regulatory filings. In addition, the Director will liaise with discovery and development colleagues to develop overall safety pharmacology and toxicology development strategies and regularly interface with internal and external colleagues to ensure timely and accurate dissemination of safety pharmacology and toxicology findings. The Director will also work collaboratively with the executive management to develop key program strategies and strengthen the capabilities AnaptysBio, which focuses on early and late clinical drug development activities evaluating the pharmacology and toxicology  of antibody therapeutics focused primarily, but not exclusively, on immune-inflammatory diseases. 

Essential Functions

•  Crafts the pre-clinical and clinical pharmacological strategies, including dose escalation, contributing to stopping rules, and risk-benefit to ascertain that compounds are entered into man safely, efficiently and with scientific validity. Establishes collaboration with CROs and/or academic institutions to develop in vivo pharmacology models to permit progression of therapeutic antibodies into the clinic Manages and works with external service provides to identify, qualify, engage and design in vitro and in vivo toxicology and safety pharmacology studies conducted under GLP- and non-GLP conditions and analyze and interpret resulting data.
• Provides input to strategic and tactical direction for multiple project teams as they advance molecules from target discovery through lead optimization to clinical development. Prepares study reports for regulatory submission on development candidates. Write toxicology and safety pharmacology sections of regulatory documents, including but not limited to the IND, IB and BLA.
• Contributes to new project ideas and in vivo proof-of-concept studies to enable the initiation of new antibody projects. Collaborate with the development project team and provide support for the transition from discovery to clinical development of new antibodies.

Supervisory Responsibilities

Hire, lead, and develop Toxicology staff

Knowledge

• Direct experience and broad knowledge of all the requirements (pharmacokinetics, toxicology, formulation etc.) needed to progress to first-in-human studies and different stage of clinical development.  
• Skilled at statistical data collection, editing, validation and analysis techniques.
• Strong knowledge of preparation of INDs, CTAs, BLAs, and MAAs.

Personal Competencies

• Extensive leadership skills and proven ability to work within multi-disciplinary teams to influence the overall direction of projects.
• Excellent communication and interpersonal skills, with the ability to effectively influence opinion and actions, and communicate strategies, plans, results and analysis, at all levels within an organization, including third parties such as CRO’s and collaborative partners. Strong publication record in reputed pharmacology or toxicology journals.
• Ability to think strategically and to provide clear direction and expectation to other team members in a highly dynamic environment.
• Strong ability to prioritize daily work based on changing business requirements.
• Self-motivated, independent, and results-oriented. 
• Team player, intensely committed to success and getting the job done well in a highly dynamic environment.
• Ability to work productively in a matrix environment, as both a team contributor and team leader, taking ownership of multiple projects. 

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to use hands to finger, handle, or feel. The employee is occasionally required to stand, walk, and reach with hands and arms. The employee must occasionally lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision and ability to adjust focus in order to read.

Work Environment

The work environment characteristics are representative of those an employee encounters while performing the essential functions of this job, typically in an open office environment or laboratory. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• The noise level in the work environment is usually quiet to moderate.
• This position requires working with biological and/or chemical hazards
• May be required to travel by plane about 20% of the time (post Covid-19)

Education & Experience

•  PhD in Toxicology/Pharmacology or related science with a minimum of 10 years’ experience in a drug-discovery and development settings of a biopharmaceutical company, accompanied by at least 5 years of proven leadership experience.
• Significant experience in all aspects of toxicology including general, developmental and reproductive toxicology, carcinogenicity, toxicokinetics, and safety pharmacology.
• Experience authoring regulatory documents and interacting with global regulatory agencies.
• Proven track record of making major contributions to the discovery or development of one or more marketed or in-development medicines.
• Prior experience of working across diverse therapeutic areas is highly desirable.
• Proven managerial competence with previous experience in directly managing teams .

All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.