Kailera Therapeutics, Inc.
Senior Clinical Trial Manager
Waltham, Massachusetts · Senior · Full-time
Sponsorship not specified$143k-$175kDetected 8 days ago
GCPComplianceProject ManagementClinical TrialsCommunicationProblem SolvingPublic SpeakingMicrosoft Office
About the role
- As we expand, we seek the most talented individuals with diverse backgrounds, cultures, perspectives, and experiences to join our team.
- CTM will be responsible for ensuring trial milestones are met on time, within budget, and in alignment with regulatory and quality standards.
- CTM will also play a critical role in process improvements and the continued development of Clinical Operations at Kailera.
Responsibilities
- 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.
- This role requires a proactive, solution-oriented professional who can collaborate cross-functionally and manage external partners with minimal oversight.
- 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
- Lead development and review of study plans and vendor SOPs
- Maintain high-quality Trial Master Files and ensure inspection readiness throughout the study lifecycle
- Lead development and review of study plans and vendor SOPs; ensure appropriate documentation and risk mitigation strategies are in place
Requirements
- 8+ years of clinical trial experience, including direct management of CROs and vendors
- Proficient in Microsoft Office Suite, and working knowledge of project management tools (e.g., MS Project, Smartsheet)
- Must be able to travel as needed
- Bachelor's degree in life sciences or a related field with 8+ years of work experience; or an advanced degree with 2+ years of experience
Nice to have
- Biotech experience preferred
- Bachelor's degree in life sciences or a related field with 8+ years of work experience
- or an advanced degree with 2+ years of experience
- Kailera Therapeutics, Inc. uses E-Verify to confirm the identity and employment eligibility of all new hires.
Compensation
- $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.
- 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.
- This range represents the company's good-faith estimate of the salary at the time of posting.
Benefits
- 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 also offer comprehensive health coverage, flexible time off, paid holidays, and a year-end shutdown.
- Actual pay may vary based on experience, skills, qualifications, location, and internal equity.
Company info
- We are passionate about creating an inclusive workplace that promotes collaboration, integrity, and excellence.
Equal opportunity
- 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.
Visa & Work Authorization
- tive 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-rel
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