Sanior Clinical Trial Manager

Kailera Therapeutics, Inc.; United States; Hybrid; USD 143,000 - 175,000; Full time

Benefits offered by this job

Health coverage

Flexible time off

Paid holidays

Wellness stipend

401(k) match

Tuition reimbursement

Commuter benefits

Equity grants

Job summary

Kailera Therapeutics, Inc. in Waltham, MA (onsite 3-4 days/week) or remote with periodic hub visits is seeking a Senior Clinical Trial Manager to lead planning, execution and oversight of trials across development phases.

You will manage CROs, vendors, study plans, data review, and TMF while mentoring team members and driving process improvements in GCP/ICH compliance. Travel required.

Qualifications

• Bachelor's degree in life sciences or a related field.
• 8+ years of clinical trial experience with CRO/vendor management.
• Strong knowledge of GCP, ICH guidelines, and global regulatory frameworks.
• Excellent written and verbal communication skills and stakeholder management.
• Willingness to travel as needed.

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 ensuring quality and regulatory compliance.
• Monitor CRO performance and resolve issues to meet timelines and budgets.
• Lead development and review of study plans and vendor SOPs with proper documentation and risk mitigation.
• Ensure timely data query resolution and corrective actions; maintain Trial Master Files and inspection readiness.
• Mentor or manage junior team members and contribute to process improvements and knowledge sharing.
• Collaborate with QA, Regulatory, and cross-functional stakeholders to ensure compliance with GCP, ICH, and global regulatory guidelines.

Skills

Clinical trial management

Cross-functional leadership

GCP/ICH knowledge

Vendor negotiations

Communication

Education

Bachelor’s degree in life sciences

Tools

MS Project

Smartsheet

Job description

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:

TheSenior 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.

Required location: Waltham, MA (hub-based, onsite 3-4 days per week) OR Remote (home-based, onsite at a hub 1 week every other month).

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; elevate 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 or manage 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:

• 8+ 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
• Obesity experience preferred

Education:

Bachelor’s degree in life sciences or a related field with 8+ years of work experience

Salary Range

$143,000 - $175,000 USD

For Full Time Roles:

This range represents the company’s good-faith estimate of the salary at the time of posting. Actual pay may vary based on experience, skills, qualifications, location, and internal equity. We also offer comprehensive health coverage, flexible time off, paid holidays, and a year-end shutdown. Enjoy a monthly wellness stipend, generous 401(k) match, tuition reimbursement, commuter benefits, disability and life insurance, plus annual bonus opportunities and equity grants—because your well-being and future matter to us.

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.