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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 experience
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
This position will require the individual to pass a physical before beginning employment.
This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business.
To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.
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