What You’ll Do:

We are seeking a highly organized and detail-oriented professional to join our Non-Clinical Development team. This individual will provide operational and administrative support across all aspects of non-clinical development, ensuring smooth execution of studies and team deliverables. The role is cross-functional, requiring close collaboration with internal stakeholders (finance, legal, program management, research teams) and external vendors/CROs. The successful candidate will be proactive, resourceful, and comfortable managing multiple priorities in a fast-paced environment.

Required location: Waltham, MA (hub-based, onsite 3-4 days per week)

 

Responsibilities: 

• Maintain and monitor non-clinical study timelines, proactively flagging risks or delays to relevant stakeholders
• Provide operational support for DMPK and bioanalytical studies
• Manage inventory of critical reagents, internal standards, and other materials for DMPK and bioanalytical needs
• Coordinate ordering of necessary study materials in collaboration with procurement
• Liaise with study directors and CROs to support project execution
• Track study milestones and deliverables for internal reporting and management
• Support the drafting, review, and execution of contracts, work orders, and amendments with CROs and external partners
• Act as the primary liaison between the non-clinical team, legal, and procurement to facilitate timely contract execution
• Maintain vendor relationship tracking and ensure CRO compliance with company policies
• Work with US and internationally based CROs in the conduct of nonclinical studies
• Prepare and submit purchase order (PO) requests for non-clinical activities
• Track invoices and ensure timely payment in coordination with the finance department
• Support budget tracking and forecasting for all non-clinical studies
• Effectively engage with the Finance department to maintain alignment with Non-Clinical Development budget forecasting and maintenance
• Serve as a central point of contact for operational needs of the non-clinical development team
• Support the preparation of team presentations, reports, and trackers
• Organize team meetings, take minutes, and ensure timely follow-up on action items
• Assist with regulatory and submission readiness activities as needed

 

Required Qualifications: 

• 6+ years of experience in pharmaceutical/biotech operations, nonclinical development, or project coordination
• Demonstrated strong organizational skills with the ability to effectively manage multiple tasks and competing priorities simultaneously
• Excellent verbal and written communication and interpersonal skills, with the ability to work effectively with cross-functional teams and external vendors
• Familiarity with contracts, budgets, and financial systems (e.g., invoice tracking, purchase orders, etc.)
• Proficiency in Microsoft Office Suite (Excel, PowerPoint, Word)

 

Preferred Qualifications: 

• Experience with project management tools is a plus
• Knowledge of GLP and the overall drug development process is strongly preferred

 

Education:

• Bachelor’s degree with 6+ years of relevant experience, or an advanced degree (MS) with experience in Toxicology, Pharmacology, or a related discipline