Associate Director Preclinical Pharmacokinetics

Organization
Regeneron
Job Location
Tarrytown, NY
Salary
NA
Benefits

NA

Job Description

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.
Summary:
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.

Responsibilities:
• 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

Requirements

Experience and Required Skills:
Requirements:
• 10+ years
• 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 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, disability status, protected veteran status, or any other characteristic protected by law.

Apply online at:
http://careers.regeneron.com/united-states/regulatory-science/jobid58512...

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