Sr. Project Manager

Rockville, MD - USA

Monthly Salary: Not Disclosed

Posted on: 22 hours ago

Vacancies: 1 Vacancy

Job Summary

Senior Project Manager

Rockville MD Full Time

Nexagen Searchis representing a biotechnology company that is hiring for an Senior Project Manager to join their team in Rockville MD.

Overview

This role will be responsible for planning executing and managingnon-clinical research projects. This pivotal role ensures the successful completion of preclinical studies toxicology programs and regulatory submissions while serving as the primary liaison between internal R&D teams and external partners/ ideal candidate combines strong scientific acumen with proven project management expertise to drive execution in a milestone-driven environment delivering high-quality data on time and within budget.

Key Responsibilities:

Project Planning & Execution

Develop project plans timelines and budgets for non-clinical studies (pharmacologyPK/PD toxicology DMPK) and coordinate studies
Define project scope deliverables and success criteria in alignment with regulatory strategies
Support other projects across different development phases under PMOs assignment

Stakeholder Management

Serve as primary point of contact for internal teams (Discovery CMC Clinical) and external partners
Lead cross-functional project core teams and drive effective communication across geographies
Provide transparent data-driven project updates to senior leadership and governance committees
Be in charge of CRO/CDMO selection contract negotiation and performance management to ensure quality and compliance

Regulatory & Compliance

Ensure all non-clinical activities comply with global GLP GCP and regulatory standards (FDA EMA NMPA)
Support preparation of regulatory submissions (IND CTA NDA BLA) with robust non-clinical data packages
Maintain inspection-ready study documentation and ensure audit preparedness
Monitor and interpret evolving regulatory guidelines from FDA EMA NMPA and ICH proactively advising project teams

Budget & Resource Management

Develop and manage project budgets track expenditures and forecast resource needs
Optimize resource allocation across projects and identify cost-saving opportunities
Manage financial aspects of CRO contracts including invoice approval and milestone payments

Risk & Quality Management

Proactively identify project risks and develop robust mitigation strategies
Implement quality standards throughout study conduct data analysis and reporting
Escalate critical issues with recommended solutions to senior management
Ensure timely deviation management and CAPA implementation

Qualifications and Experience

Master or Ph.D in Life Sciences (Biology Pharmacology Toxicology or related field
5-10 years experiences in biotech/pharma R&D functions with 3 years of non-clinical project management experience.
Proven track record of CRO/CDMO management
Understanding of FDA EMA and ICH guidelines for non-clinical studies
Excellent scientific writing and regulatory documentation skills; experience with pre-IND/IND

Recruiter in Charge:Jeff Caskey

Managing Partner

Required Experience:

Senior IC

Senior Project ManagerRockville MD Full TimeNexagen Searchis representing a biotechnology company that is hiring for an Senior Project Manager to join their team in Rockville MD.OverviewThis role will be responsible for planning executing and managingnon-clinical research projects. This pivotal rol...