𝐒𝐞𝐧𝐢𝐨𝐫 𝐃𝐢𝐫𝐞𝐜𝐭𝐨𝐫, 𝐃𝐫𝐮𝐠 𝐃𝐢𝐬𝐩𝐨𝐬𝐢𝐭𝐢𝐨𝐧, 𝐀𝐃𝐌𝐄
This is an on-site role in the USA.
World-leading global pharmaceutical company searching for a passionate leader for a dynamic position, guiding and leading a multifaceted group of ADME scientists focused on the ADME/PK support of biologics and hybrid modalities.
The successful candidate must have not only an established history of people management and scientific leadership but also a collaborative and innovative approach to challenge historical workflows and drive a new standard of excellence
This Pharma is committed to incorporating novel modalities in drug discovery and delivery, and arguably the most exciting pipeline in industry right now with 4/5 launches (including blockbusters) expected soon.
- Lead a group of scientists with ADME/PK responsibilities across therapeutic areas from discovery through the late stages of drug development.
- Provide scientific and administrative leadership. Allocate and prioritize resources, collaborate on scientific and business issues
- Review and approve Drug Disposition study designs, regulatory reports, methods, standard operating procedures, and other documents sent externally
- Review Drug Disposition global regulatory submission documents and responses, Tox/Drug Disposition plans, data packages prepared for internal governance committees and in-license / out-license data packages for content and quality
- Represent ADME on cross-functional critical initiatives
- Evaluate new technologies, techniques, study designs or equipment and assess the applicability to current or future functional area needs
- PhD in a scientific field preferably related to drug metabolism and pharmacokinetics (DMPK) or pharmaceutical sciences
- 5+ years of job experience in a DMPK-related field
- Prior group leadership/people management experience
- Experience with drug discovery and/or development and knowledge of regulatory processes
- Experience with PK/drug disposition of one or more of the following: biologics, peptides, siRNA, gene therapies
- Experience with small molecule ADME/PK