Senior Clinical Trial Manager

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:

The Senior Clinical Trial Manager (Sr. CTM) will manage the planning, execution, and oversight of one or more clinical trials across all phases of development. Acting as a key operational lead, the Sr. CTM will be responsible for ensuring trial milestones are met on time, within budget, and in alignment with regulatory and quality standards. This role requires a proactive, solution-oriented professional who can collaborate cross-functionally and manage external partners with minimal oversight. The Sr. CTM will also play a critical role in process improvements and the continued development of Clinical Operations at Kailera.

Preferred location: Waltham, MA (onsite or hybrid 2-3 days per week).

Responsibilities:

• Serve as the primary operational lead for assigned clinical trials, accountable for end-to-end trial execution, including oversight of CROs and vendors from study start-up through close-out.
• Lead cross-functional trial teams to ensure alignment on timelines, deliverables, risk mitigation, and study objectives.
• Independently manage key trial activities, such as protocol development, site selection, study conduct, monitoring, data review, and database lock.
• Oversee and review key clinical trial documents (e.g., informed consent forms, Investigator Brochures, monitoring plans), ensuring quality and regulatory compliance.
• Monitor CRO performance to ensure adherence to study plans, timelines, budgets, and quality expectations; escalate and resolve issues proactively.
• Lead development and review of study plans and vendor SOPs; ensure appropriate documentation and risk mitigation strategies are in place.
• Ensure timely data query resolution, review of protocol deviations, and follow-through on site-related corrective actions.
• Maintain high-quality Trial Master Files and ensure inspection readiness throughout the study lifecycle.
• Mentor junior team members and contribute to departmental process improvements and knowledge-sharing initiatives.
• Collaborate with QA, Regulatory, and cross-functional stakeholders to ensure continuous compliance with GCP, ICH, and global regulatory guidelines.

Required Qualifications:

• 7+ years of clinical trial experience, including direct management of CROs and vendors.
• Proven ability to lead cross-functional study teams and drive clinical programs forward independently.
• Deep understanding of GCP, ICH guidelines, and regulatory frameworks relevant to global clinical trial management.
• Strong problem-solving, organizational, and analytical skills with the ability to anticipate challenges and implement solutions.
• Excellent written and verbal communication skills, including stakeholder presentations and vendor negotiations.
• Ability to manage multiple priorities in a fast-paced environment and lead initiatives with minimal oversight.
• Proficient in Microsoft Office Suite, and working knowledge of project management tools (e.g., MS Project, Smartsheet).
• Must be able to travel as needed.

Preferred Qualifications:

• Biotech experience preferred.

Education:

• Bachelor’s degree in life sciences or a related field; advanced degree is a plus.

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.

 #LI-Hybrid