Manager, Nonclinical Operations

At Kailera, we are bold, authentic and committed to our mission of developing therapies that give people the power to transform their lives and elevate their overall health. Rooted in an entrepreneurial spirit and a team-oriented culture, we are working together to advance Kailera’s mission to advance novel therapies for obesity and related conditions.
 
We are passionate about creating an inclusive workplace that promotes collaboration, integrity, and excellence. As we expand, we seek the most talented individuals with diverse backgrounds, cultures, perspectives, and experiences to join our team.

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

EQUAL EMPLOYMENT OPPORTUNITY INFORMATION: 

Kailera Therapeutics, Inc. is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race (including traits historically associated with race, such as hair texture and protective hairstyles), color, creed, religion (including religious dress and grooming practices), national origin, ancestry, citizenship status, age (40 and over), sex or gender (including pregnancy, childbirth, pregnancy-related conditions, and lactation), gender identity or expression (including transgender status), sexual orientation, marital status, military service and veteran status, physical or mental disability, genetic information, reproductive health decisions, domestic victim status, political affiliation, or any other characteristic protected by applicable federal, state, or local laws and ordinances.

E-Verify:

Kailera Therapeutics, Inc. uses E-Verify to confirm the identity and employment eligibility of all new hires.

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