Job Title: Associate Director/Director, DMPK
Job Number: 21521
Location: Lexington, MA
We are seeking a highly motivated and scientifically rigorous individual to join our team as Associate Director/Director in Drug Metabolism and Pharmacokinetics. 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 analyses, modeling, expertise, representation and resources to all discovery and development teams and TBio management across all therapeutic areas and stages of development.
- Expertise in small and large molecules; RNA experience preferred.
- Provide scientific ownership of the DMPK function; 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 studies (eg, bioavailability, ADME, bioequivalence, DDI, food-effect).
- Highly analytical, decisive, goal-oriented, and timeline sensitive while maintaining the highest of scientific and ethical standards.
- The DMPK lead 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 DMPK lead will establish and maintain appropriate quality systems and procedures for outsourcing, managing and reporting for DMPK studies and other activities in support of TBio portfolio programs, and provide submission-ready documentation for the DMPK components of regulatory submissions
- PhD in a related subject.
- 6-10 years industry-related experience in discovery and regulatory DMPK working within the biotechnology or pharmaceutical industry, including previous work with nucleic acid therapeutics. Bioanalytical expertise would be preferred.
- Extensive training and experience in 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 studies conducted by qualified suppliers.
- 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.