Senior Manager/Associate Director, Project Management
Rockville, MD | Full Time
Nexagen Search is representing a biotechnology company that is hiring for an experienced Project Manager to join their team in Rockville, MD.
Overview
This role will be responsible for planning, executing, and managing non-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/CROs. The 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 (pharmacology,PK/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 PMO’s 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 – jeff@nexagensearch.com