Sr Subject Matter Expert, DMPK Regulatory Submission - CRO

Sr DMPK ExpertSeeking Sr DMPK expert to lead/report DMPK studies for Regulatory Submissions for a Global, publicly-traded, integrated CRO in small molecules.Job DescriptionLead global DMPK regulatory strategy for drug development programs. Provide expert oversight for DMPK sections of IND, NDA, and related submissions. Interface directly with regulatory authorities on scientific and strategy matters. Support and guide international teams, including those in Asia-Pacific regions. Contribute to business development through client engagement and proposal input. Mentor scientists and enhance internal knowledge of regulatory best practices. Represent the organization through publications, conferences, and industry forums. Monitor and apply evolving regulatory guidance to program strategy.MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.The Successful ApplicantPhD in a relevant scientific discipline (e.g., Pharmacology, Pharmaceutical Sciences). 20+ years of industry experience in DMPK within pharmaceuticals or biotech. Demonstrated success supporting IND/NDA submissions. Strong experience interacting with global regulatory agencies (e.g., FDA, EMA). Established professional reputation and network within the DMPK field.What's on OfferCompetitive base salary & package. Visibility to senior leadership. Interacts with senior stakeholders internally and externally with Big Pharma customers. Fantastic culture: team made up of science-driven, patient-centric staff who are highly collaborative at all levels. Remote position based anywhere in the US. Strong benefits package. Global CRO which has consistently grown YoY over the last 5+ years.Job SummarySector: Life SciencesSub Sector: BiotechnologyIndustry: Healthcare / PharmaceuticalLocation: CambridgeContract Type: Permanent