We are seeking a highly motivated and scientifically rigorous individual to join our team as Director of Drug Metabolism, Pharmacokinetics, and Bioanalysis (DMPK/BA). The successful candidate will report to Head of Translational Development and be an integral part of the Research and Development team.
- Responsible for providing DMPK/BA strategy, expertise, representation and resources to all discovery and development teams and TBio management across all therapeutic areas and stages of development.
- Provide strong management skills and demonstrate ability to manage and lead an experienced team
- Provide scientific leadership and oversight of the DMPK/BA group; working closely with Discovery, Chemistry, Regulatory and Clinical colleagues to generate and integrate PK, ADME and BA data leading to the estimation of safe and efficacious first in human clinical dose and regimen for novel therapeutics, as well as predicted clinical PK and PK/PD profiles and optimal posology.
- Responsible for scientific leadership, design, analysis and reporting for all phase-appropriate and registration-enabling DMPK and BA studies (eg, bioavailability, ADME, bioequivalence, DDI, food-effect). In addition, the DMPK/BA organization will be responsible for development and validation of bioanalytical methods for mRNA, lipids, protein and biomarkers for nonclinical and clinical development programs.
- The Head of DMPK/BA is expected to maintain a flat, consensus-driven team and to balance big picture, long-term and strategic considerations with tactical, detailed technical aspects in approaching and dealing with program-related DMPK/BA issues
- Highly analytical, decisive, goal-oriented, and timeline sensitive while maintaining the highest of scientific and ethical standards.
- The Head of DMPK/BA develops and implements strategic plans for preclinical and clinical pharmacokinetics and actively participates in program teams, providing expert representation to global regulatory agencies as well as collaborating with R&D leadership and assisting in the identification of new business initiatives and in-licensing opportunities.
- The Head of DMPK/BA will establish and maintain appropriate quality systems and procedures for outsourcing, managing and reporting for DMPK/BA studies and other activities in support of TBio portfolio programs, and provide submission-ready documentation for the DMPK/BA components of regulatory submissions
- PhD in a related subject.
- 10+ years industry-related experience in discovery and regulatory DMPK/BA working within the biotechnology or pharmaceutical industry, including previous work with nucleic acid therapeutics.
- Extensive training in bioanalytical methods and approaches, pharmacokinetic analysis and biostatistics, including construction of PK and PK/PD models, simulation, and prediction of first-in-human and human equivalent doses is required.
- Hands-on experience in all aspects of DMPK study conduct, including: study design, execution, interpretation and reporting, in vitro/in vivo PK & PD and ADME, methods, animal models, inter-species scaling, advanced data analysis, modeling and simulation, reporting and compliance.
- Experience authoring relevant sections of regulatory documents and providing expert representation to global regulatory agencies in support of submissions at all stages of development, ie, IND/CTA, CTD, IMPD, MAA/NDA/BLA/JNDA.
- Extensive experience in the outsourcing and external oversight of DMPK/BA studies conducted by qualified suppliers.
- Experience in setting up / establishing appropriate analytical and BA methods that are fit for purpose to support discovery and development.
- Experience in providing formal scientific/technical due diligence support for Business Development activities is required.
- Evidence of leadership within the industry, eg such as through peer-reviewed publications or as a participant on expert panels or working groups, is preferred.
- Must be motivated, creative, energetic, resourceful and adaptable, responding constructively to challenge, new ideas, information, situations or criticism.
- Must be able to balance big picture thinking with fine detail level analysis and have demonstrated ability in problem solving as applied to drug development and program/functional management.
- Fluency in written and spoken English is required.
- Domestic and occasional international travel required.
Translate Bio is committed to equal employment opportunity. All applicants must have authorization to work in the U.S.