Hays · 2 days ago
Senior Project Manager (Non-Clinical Studies)
DC-Baltimore Area
Full-time
Onsite
Senior Level
$140K/yr - $160K/yr
5+ years expHays is a fast-growing clinical-stage company seeking a Senior Project Manager to oversee non-clinical research projects. This role involves planning, executing, and managing preclinical studies, ensuring compliance with regulatory standards, and serving as the primary liaison between internal teams and external partners.
Information ServicesRecruitingStaffing Agency
Responsibilities
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
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 (primarily US and China)
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
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
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
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
Qualification
Required
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 FDA interactions
Preferred
Research or industry experience in neurodegenerative diseases is highly desirable
IND-enabling project management experience in the field of neurodegenerative disease
Company
Hays
Hays is a leading global professional recruiting group, they are expert at recruiting qualified, professional and skilled people worldwide. It is a sub-organization of Hays plc.
5001-10000 employees
Funding
Current Stage
Late StageLeadership Team
Manu Saigal
Country Manager - India
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