Job Summary and Essential Functions:
Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron markets medicines for eye diseases, colorectal cancer, and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including hypercholesterolemia, oncology, rheumatoid arthritis, allergic asthma, and atopic dermatitis.
The Associate Director of the Preclinical Pharmacokinetics group will be responsible for leading a small group of scientists responsible for the design, pharmacokinetic analysis, and reporting of non-clinical animal pharmacokinetic, toxicokinetic, and ADME studies, as needed. The Associate Director of Preclinical Pharmacokinetics will also provide assistance to the Director of Preclinical PK in the oversight of external pharmacokinetic studies, establishing deliverables, maintaining timelines, and fostering open communication with and between the Project Teams, Preclinical Operations, members of the Preclinical PK group, and various Functional areas. Responsibilities will further include reviewing and providing content and subject matter expertise relating to preclinical pharmacokinetics, toxicokinetics and ADME sections of regulatory documents to include: INDs, BLAs and other regulatory submissions and responses, as needed.
• In concert with the Director of Preclinical PK, manage a team of PK scientists tasked with multiple programs with competing and aggressive time lines, prioritizing activities, and working independently.
• Effectively manage the preclinical PK team tasked with study design, protocol development and study execution of GLP and non-GLP pharmacokinetic, toxicokinetic, and ADME (as needed) studies.
• Provide input to the toxicokinetic design in animal toxicology studies.
• Supervise, assist, and mentor contributing scientists on pharmacokinetic analysis, data interpretation, and report writing.
• Empower subordinates and provide for the professional development of staff.
• Function as principal investigator responsible for externally conducted PK, TK and ADME (as needed) studies as appropriate.
• Interact with the Scientific Writing Group in the creation of preclinical PK/TK written and tabulated summaries for IND and BLA applications, as well as IBs, annual updates and other regulatory activities.
• Interact closely with the bioanalytical assay development and sample analysis groups to ensure seamless and timely transfer of bioanalytical and ADA data to the Preclinical PK group.
• Comply with all pertinent SOPs and GLP regulations.
• Serve on project teams as subject matter expert for Preclinical pharmacokinetics
• Effectively communicate project team queries, requests and expectations (i.e. timing and deliverables) from the Project Teams to subordinates and management.
• Represent Regeneron in a professional manner, foster a cooperative and team relationship with partner organizations.
• Represent Preclinical PK in the absence of the Director, Preclinical PK