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 commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases.
The Director of the Preclinical Pharmacokinetics and Pharmacodynamics group will be responsible for leading a group of scientists responsible for the design, pharmacokinetic analysis, and reporting of non-clinical animal pharmacokinetic, toxicokinetic, and ADME studies. The Director will be responsible for the oversight of external pharmacokinetic studies, establish deliverables, maintain timelines, and foster open communication with and between the Project Teams, Preclinical Operations, members of the Preclinical PK/PD group, Pharmacometrics, Toxicology and Functional Heads. Responsibilities will also 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 Senior Director of Preclinical PK/PD, 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 their staff.
• Functions as study director or principal investigator responsible for externally conducted PK, TK and ADME (as needed) studies as appropriate.
• Interact with the Scientific Writing Team 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 other managers and contributing scientists tasked with bioanalytical assay development, and/or sample analysis to ensure seamless and timely transfer of bioanalytical and ADA data to the Preclinical PK/PD team.
• Comply with all pertinent SOPs and GLP regulations.
• Effectively communicate project team queries, requests and expectations (i.e. timing and deliverables) from the Project Functional 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 Senior Director, Preclinical PK
• PhD, in pharmacokinetics or a biological or related discipline (e.g. pharmacology, toxicology, biology. biochemistry, pharmaceutical science).
• 12+ Years of Post-Doctoral experience, including significant experience in biotech/ pharmaceutical industry
• Good understanding of both theoretical pharmacokinetics theory and practical application of those principles
• Experience in contributing to pharmacokinetic summaries for regulatory documents successfully submitted to regulatory agencies.
• Advanced scientific writing skills
• Experience in animal PK/TK studies, including protocol design & study conduct
• Experience with PK software and have an understanding of non-compartment & multi-compartment modeling
• Staying current with latest industry development by reading scientific journals and attending national meetings
• Maintains a compliant work environment by staying current with SOPs and being up-to-date with existing GLP guidelines
Employer will assist with relocation costs.
Additional Salary Information: Competitive
Internal Number: 14230BR
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 commercializes medicines for cancer, eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain and infectious diseases.