Senior Subject Matter Expert, DMPK, Sr/Exe Director
Page Executive, Boston, MA, United States
Role Overview
This is a Global leading CRDMO for life science industry.
This DMPK expert will make tremendous contribution to R&D project
About Our Client This company operates within the life science industry, delivering cutting-edge solutions and services to clients worldwide. As a large organization, it is recognized for its commitment to scientific innovation and excellence in research.
Job Description Key Responsibilities:
Serve as the global DMPK regulatory strategy lead for complex drug development programs, ensuring alignment with international regulatory requirements (e.g., FDA, EMA, NMPA).
Provide expert advice and oversight on DMPK-related sections of IND, NDA, and other regulatory dossiers, with a focus on supporting teams in China.
Lead interactions and negotiations with regulatory authorities (FDA, EMA, etc.) on DMPK-related matters, including pre-IND/NDA meetings, written responses, and advisory committee meetings.
Mentor and train junior scientists and project teams on DMPK regulatory strategies, submission best practices, and emerging global trends.
Collaborate with business development and project management teams to support client engagements, proposal development, and market expansion initiatives, particularly in the U.S. and Europe.
Maintain and enhance the company's scientific reputation through publications, conference presentations, and active participation in industry working groups.
Stay abreast of evolving regulatory guidelines and industry standards to ensure cutting-edge, compliant strategies.
MPI does not discriminate on the basis of race, religion, sex, sexual orientation, gender identity or expression, age, disability, marital status, or based on an individual's status in any group or class otherwise protected under applicable human rights legislation. MPI encourages applications from minorities, women, the disabled and all other qualified applicants.
The Successful Applicant Key Requirements:
PhD in Pharmaceutical Sciences, Pharmacology, Biochemistry, or a related field, with 20+ years of direct DMPK experience in the pharmaceutical industry.
Proven track record of leading DMPK strategies and contributions to successful IND/NDA submissions for small molecules and/or biologics, preferably within a top-tier multinational pharmaceutical company.
Extensive hands‑on experience interacting with major regulatory agencies (FDA, EMA, etc.), including direct communication and negotiation on DMPK topics.
Strong reputation and visibility in the DMPK field, particularly in the U.S. market, with a network of industry and regulatory contacts.
Demonstrated ability to provide strategic guidance to cross‑functional and geographically dispersed teams, with experience supporting China/Asia‑Pacific projects being a significant advantage.
Excellent communication and presentation skills.
Willingness to travel internationally as needed.
What's on Offer
Competitive salary ranging from $250000 to $300000 USD annually.
Access to local standard benefits to support your well‑being.
Opportunity to work in a large organization at the forefront of the life science industry.
Collaborative and innovative work environment.
Potential to contribute to groundbreaking research and development projects.
If you are an experienced professional eager to make a significant impact in the field of Drug Metabolism and Pharmacokinetics (DMPK), apply today to join this exciting opportunity in Boston!
#J-18808-Ljbffr
This is a Global leading CRDMO for life science industry.
This DMPK expert will make tremendous contribution to R&D project
About Our Client This company operates within the life science industry, delivering cutting-edge solutions and services to clients worldwide. As a large organization, it is recognized for its commitment to scientific innovation and excellence in research.
Job Description Key Responsibilities:
Serve as the global DMPK regulatory strategy lead for complex drug development programs, ensuring alignment with international regulatory requirements (e.g., FDA, EMA, NMPA).
Provide expert advice and oversight on DMPK-related sections of IND, NDA, and other regulatory dossiers, with a focus on supporting teams in China.
Lead interactions and negotiations with regulatory authorities (FDA, EMA, etc.) on DMPK-related matters, including pre-IND/NDA meetings, written responses, and advisory committee meetings.
Mentor and train junior scientists and project teams on DMPK regulatory strategies, submission best practices, and emerging global trends.
Collaborate with business development and project management teams to support client engagements, proposal development, and market expansion initiatives, particularly in the U.S. and Europe.
Maintain and enhance the company's scientific reputation through publications, conference presentations, and active participation in industry working groups.
Stay abreast of evolving regulatory guidelines and industry standards to ensure cutting-edge, compliant strategies.
MPI does not discriminate on the basis of race, religion, sex, sexual orientation, gender identity or expression, age, disability, marital status, or based on an individual's status in any group or class otherwise protected under applicable human rights legislation. MPI encourages applications from minorities, women, the disabled and all other qualified applicants.
The Successful Applicant Key Requirements:
PhD in Pharmaceutical Sciences, Pharmacology, Biochemistry, or a related field, with 20+ years of direct DMPK experience in the pharmaceutical industry.
Proven track record of leading DMPK strategies and contributions to successful IND/NDA submissions for small molecules and/or biologics, preferably within a top-tier multinational pharmaceutical company.
Extensive hands‑on experience interacting with major regulatory agencies (FDA, EMA, etc.), including direct communication and negotiation on DMPK topics.
Strong reputation and visibility in the DMPK field, particularly in the U.S. market, with a network of industry and regulatory contacts.
Demonstrated ability to provide strategic guidance to cross‑functional and geographically dispersed teams, with experience supporting China/Asia‑Pacific projects being a significant advantage.
Excellent communication and presentation skills.
Willingness to travel internationally as needed.
What's on Offer
Competitive salary ranging from $250000 to $300000 USD annually.
Access to local standard benefits to support your well‑being.
Opportunity to work in a large organization at the forefront of the life science industry.
Collaborative and innovative work environment.
Potential to contribute to groundbreaking research and development projects.
If you are an experienced professional eager to make a significant impact in the field of Drug Metabolism and Pharmacokinetics (DMPK), apply today to join this exciting opportunity in Boston!
#J-18808-Ljbffr