Lead Pharmacologist/Toxicologist

Here's how this role creates impact:

• Applies scientific methodology and propose solutions to pharmacology and toxicology hurdles based on interpretation of previous results, studies and/or information gathered from external sources. Provides scientific feedback to other departments as needed.
• Serves as Global Pharmacology and Toxicology Lead for developmental programs for Complex drug products, assisting in design, completion, and defense of development programs under direction of supervisor. Leads the research and construction of regulatory study documents for a developmental program, technical scientific analyses, and positional papers (i.e., IND/NDA documents, Applications for Marketing Authorizations, etc.)
• Assists in the selection and approval of contract testing facilities used for nonclinical studies, oversight to ensure appropriate timely initiation, progression, and completion of studies per projects timelines. Ensuring data quality and integrity from preclinical sites.
• Reviews for comprehension relevant Standard Operating Procedures (SOPs).
• May manage other scientists, chemists, and assistants towards completion of project goals under direction of supervisor. May serve as direct line manager for small number of employees.
• Represents the department in meetings with global regulatory health authorities and attending internal meetings.

Key responsibilities for this role include:

• Candidates must possess an earned doctoral degree in Toxicology, Pharmacology or related field and 5 + years of experience in toxicology and pharmacology, or an earned master’s degree in an appropriate field with at least 8+ years of full-time professional post-baccalaureate experience (or part-time equivalent thereof) in toxicology and pharmacology, or must possess an earned bachelor’s degree in an appropriate field and have at least 10+ years professional post-baccalaureate experience (or part-time equivalent thereof) in toxicology/pharmacology. 
• Must possess knowledge of the biological impact of drug product materials (APIs, excipients, impurities, etc.) in the human body. Knowledge of applicable world health authorities’ regulations, standards and guidelines covering drug development is essential. The knowledge and application of GLP and ISO regulations is required.  Previous experience in ophthalmology products development is a plus.
• Must possess effective oral and written communication, organizational and computer skills.  Must be able to interact with a diverse workgroup in a team-oriented environment with the ability to communicate performance expectations in a clear and concise manner. Proactive team player and flexibility to work on multiple projects as the programs evolve over time.
• Position functions semi-autonomously. The position may directly supervise employees.  Must carry out supervisory responsibilities in accordance with the organization's policies and applicable laws.  Responsibilities may include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
• Ability to read and interpret comprehensive and intricate research documents.  Ability to write scientific reports and technical correspondence.  Ability to work with executives and communicate abstract concepts.   Ability to present to a high level of the organization and groups outside of the organization.
• Ability to solve equations, apply technical mathematical concepts, and perform complex computations.
• Ability to solve problems with complex variables through non-standardized solutions that require independent judgment and analysis. Ability to draw inferences and use deductive reasoning with no prescribed procedures to solve complex problems.
• Normal office situation.
• Proficiency in speaking, comprehending, reading and writing English is required.