Sr Subject Matter Expert, DMPK Regulatory Submission - CRO

Cambridge, Massachusetts Permanent USD200,000 - USD250,000 per year View Job Description
In conjunction with the global BD team, this senior role provides strategic leadership in DMPK for regulatory submissions, supporting complex programs across global markets. You will collaborate cross-functionally to drive successful IND/NDA outcomes and expand scientific and commercial impact.
  • Seeking Sr DMPK expert to lead/report DMPK studies for Regulatory Submissions
  • Global, publicy-traded, integrated CRO in small molecules

About Our Client

This client is a global CRO which has recently surpassed $2b in annual revenue due to growth and reputation. The business specializes in small molecules & biologics drug discovery and development services and offers a fully integrated program for its biotech & pharma clients.

Job Description

  • Lead 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 Applicant

  • PhD 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 Offer

  • Competitive 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
Contact
Daniel Ferzoco
Quote job ref
JN-062026-7042918

Job summary

Sector
Life Sciences
Sub Sector
Biotechnology
Industry
Healthcare / Pharmaceutical
Location
Cambridge
Contract Type
Permanent
Consultant name
Daniel Ferzoco
Job Reference
JN-062026-7042918