New · posted Nov 10
Kailera · Biotechnology
Senior Clinical Trial Manager
- Remote, US
- Remote
- Full-time
- Manager
The role
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 need
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
Education
Bachelor’s degree in life sciences or a related field with 8+ years of work experience
Preferred Qualificationsnice to have
- Biotech experience preferred
- Obesity experience preferred
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.
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).
- 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 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
Pay and benefits
$143,000 – $175,000 a year
Employer provided$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.
Comprehensive health coverage
Flexible time off and paid holidays
Monthly wellness stipend
401(k) match
Annual bonus and equity grants
Tuition reimbursement
Equal opportunity, accessibility and legal noticesKailera's statements, word for word
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.
Job intelligence
The context around this role
Live data · November 10, 2026
Salary intelligence
How the pay compares
This role's midpoint is 1% below the US median for Clinical Trial Management roles at this level.
This roleEmployer provided
Manager roles in the US46 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $143,000 | — | $175,000 |
| All US (middle half) | $143,375 | $161,250 | $169,500 |
This role: Kailera's own published range. Comparisons: the base pay employers published on open Clinical Trial Management roles at the same level on Regulatory Jobs, November 10, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Clinical Trial Management
The general path across 76 open Clinical Trial Management roles on Regulatory Jobs, with the titles they carry most. Not Kailera's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 24 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership10
- Clinical trial conduct8
- GMP and compliance4
- Documentation and SOPs3
- Investigations and CAPA2
- Quality systems and risk2
- Lab testing and methods1
- Data and digital systems1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Clinical Trial Management work in biotechnology, led by the one this posting names, each linked to the agency or standards body that publishes it.
- ICHICH E6(R3) good clinical practice(official source, opens in a new tab)The international standard for the design, conduct and reporting of clinical trialsNamed in the posting
- FDA21 CFR Part 312(official source, opens in a new tab)Investigational New Drug applications and sponsor duties in drug trials
- FDA21 CFR Part 50(official source, opens in a new tab)Protection of human subjects: informed consent in FDA-regulated trials
- FDA21 CFR Part 56(official source, opens in a new tab)Institutional review boards for FDA-regulated clinical investigations
- ICHICH E8(R1)(official source, opens in a new tab)General considerations for clinical studies and quality by design in trials
- FDAFDA Investigations Operations Manual(official source, opens in a new tab)How FDA investigators plan and conduct inspections
- EUEU Clinical Trials Regulation 536/2014(official source, opens in a new tab)How clinical trials of medicines are authorized and run in the EU, through CTIS
- HHS45 CFR Part 46 (Common Rule)(official source, opens in a new tab)The federal policy for the protection of human research subjects
- NIH42 CFR Part 11(official source, opens in a new tab)Clinical trial registration and results reporting on ClinicalTrials.gov
- FDAFDA Bioresearch Monitoring (BIMO)(official source, opens in a new tab)FDA inspections of clinical investigators, sponsors, IRBs and GLP labs
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signatures
- HHSHIPAA Privacy Rule(official source, opens in a new tab)Federal protections for individually identifiable health information
- EUGDPR (Regulation 2016/679)(official source, opens in a new tab)The EU General Data Protection Regulation for personal data, including health data
- ICHICH E9 and E9(R1)(official source, opens in a new tab)Statistical principles for clinical trials and estimands
- FDA21 CFR 314.80 and 600.80(official source, opens in a new tab)Postmarketing reporting of adverse drug and biologic experiences
- ICHICH E2A to E2F(official source, opens in a new tab)Clinical safety data management, expedited reporting and periodic safety reports
Company hiring pulse
Kailera on Regulatory Jobs
- 13
- Open roles
- 13
- Distinct roles
- 3
- Locations
By discipline
- Regulatory6 46%
- Clinical6 46%
- Quality1 8%
By level
- Director9 69%
- VP & Executive2 15%
- Manager1 8%
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Senior Clinical Trial Manager at Kailera
Open until filled. $143K–$175K a year, employer provided.