The final salary or hourly wage, as applicable, paid to each candidate/applicant for this position is ultimately dependent on a variety of factors, including, but not limited to, the candidate’s/applicant’s qualifications, skills, and level of experience as well as the geographical location of the position.

Applicants must be legally authorized to work in the United States. Visa sponsorship not available.

Our client is seeking a Senior Project Manager in Rockville, MD.

Role Description

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 (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
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

Skills & Requirements

• Master or PhD 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.
• Research or industry experience in neurodegenerative diseases is highly desirable.
• IND-enabling project management experience in the field of neurodegenerative disease

Benefits/Other Compensation:

Medical, Dental, Life Insurance, 401K.

Why Hays?

You will be working with a professional recruiter who has intimate knowledge of the industry and market trends. Your Hays recruiter will lead you through a thorough screening process in order to understand your skills, experience, needs, and drivers. You will also get support on resume writing, interview tips, and career planning, so when there’s a position you really want, you’re fully prepared to get it.

Nervous about an upcoming interview? Unsure how to write a new resume?

Visit the Hays Career Advice section to learn top tips to help you stand out from the crowd when job hunting.

Hays is committed to building a thriving culture of diversity that embraces people with different backgrounds, perspectives, and experiences. We believe that the more inclusive we are, the better we serve our candidates, clients, and employees. We are an equal employment opportunity employer, and we comply with all applicable laws prohibiting discrimination based on race, color, creed, sex (including pregnancy, sexual orientation, or gender identity), age, national origin or ancestry, physical or mental disability, veteran status, marital status, genetic information, HIV-positive status, as well as any other characteristic protected by federal, state, or local law. One of Hays’ guiding principles is ‘do the right thing’.
We also believe that actions speak louder than words.
In that regard, we train our staff on ensuring inclusivity throughout the entire recruitment process and counsel our clients on these principles. If you have any questions about Hays or any of our processes, please contact us.

In accordance with applicable federal, state, and local law protecting qualified individuals with known disabilities, Hays will attempt to reasonably accommodate those individuals unless doing so would create an undue hardship on the company. Any qualified applicant or consultant with a disability who requires an accommodation in order to perform the essential functions of the job should call or text 813.336.5570.

Drug testing may be required; please contact a recruiter for more information.

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