Introduction of the Company

SciNeuro Pharmaceuticals is a clinical-stage biotechnology company focused on developing disease-modifying therapies for neurodegenerative diseases. Since its founding in 2020, SciNeuro, headquartered in Rockville Maryland, has built a portfolio of pipeline programs staged from discovery to early clinical development by addressing three key disease-driving mechanisms of neurodegeneration – neurovascular inflammation, proteinopathy, and immune response. These interactive mechanisms allow for multiple and exciting treatment options for the various indications the company is developing therapies for including Alzheimer’s disease, Parkinson’s disease, and other devastating CNS diseases. SciNeuro has established itself as a recognized player in neurodegeneration. SciNeuro has formed collaborations with GSK, Eli Lilly, and numerous other innovative partners who provide the company with access to unique and differentiated technologies. SciNeuro is backed by blue-chip investors led by ARCH Venture Partners and Lilly Asia Ventures.

For more information on SciNeuro, please visit scineuro.com.

The Position

The Senior Project Manager is 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.

What You Will Love about This Opportunity

• A fast-growing clinical-stage company with great career advancement potential.
• A multi-asset company with promising and innovative programs.
• Great team and great science. You will be working with CEO who is a world-renowned neuroscientists and senior leaders from large pharma/top CRO with solid industrial experience.
• A company with an emerging market angle representing career expansion and commercial optionality.
• A collaborative organization with functional interdependence and synergy, covering from discovery to development and externally with investors and partners.

Title: Sr. Project Manager

Location: Rockville, Maryland, USA or Shanghai, China

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 (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

Core 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 FDA interactions.

Desired Additional Experience

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

Job Type: Full-time

Pay: $100,000.00 – $150,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Parental leave
• Retirement plan
• Vision insurance

Education:

• Master’s (Required)

Experience:

• Non-clinical project management: 3 years (Required)
• R&D in Biotech or Pharma: 5 years (Required)

Language:

• English (Required)
• Chinese (Preferred)

Location:

• Rockville, MD 20850 (Required)

Ability to Commute:

• Rockville, MD 20850 (Required)

Ability to Relocate:

• Rockville, MD 20850: Relocate before starting work (Required)

Work Location: In person