Director, Clinical 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:

The Director, Clinical Operations will provide strategic leadership and operational oversight for assigned clinical programs, ensuring the successful execution of Phase I-IV clinical trials in alignment with corporate objectives. This role is responsible for managing clinical trial operations to meet program goals, timelines, budgets, and quality expectations, while ensuring full compliance with regulatory requirements (FDA, GCP, ICH, and other applicable guidelines).

The Director will also drive the development and implementation of best practices for clinical trial execution, optimize monitoring and project management strategies, and lead continuous improvement initiatives to enhance operational efficiencies across the clinical development portfolio.

 

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

 

Responsibilities:

• Support clinical trial management, budgeting, and resourcing efforts at the program level, serving as a key Clinical Operations lead on assigned programs.
• Collaborate with the SVP, Clinical Development Operations, to align trial-level resources and budgets with broader program needs and timelines.
• Provide operational leadership to clinical study teams to ensure trial execution is consistent with program objectives and corporate timelines.
• Prepare and communicate clinical trial updates—including status, timelines, budgets, and risk assessments—to Program Leaders and Clinical Operations leadership.
• Contribute to continuous improvement initiatives, including development and refinement of SOPs, Work Instructions, training content, and compliance tools.
• Manage clinical trial activities such as CRO/vendor oversight, study execution, risk management, and GCP compliance across assigned trials.
• Contribute to the development and execution of study-level monitoring strategies to ensure quality and operational excellence.
• Participate in the selection and oversight of external partners to support study needs and ensure high-quality deliverables.
• Implement clinical monitoring approaches and tools that promote efficiency, data integrity, and regulatory compliance.
• Support the creation and maintenance of monitoring SOPs and associated tools, including monitoring plans and visit templates.
• Partner with Quality Assurance to address and resolve issues identified during audits of study sites and vendors.

 

Required Qualifications:

• 10+ years of clinical research experience, with 6-8 years in clinical trial management (e.g., project manager or equivalent role) within a pharmaceutical, biotech, or CRO setting.
• 2-4 years of prior supervisory and leadership experience in clinical operations.
• Strong knowledge of GCP, FDA regulations, and ICH guidelines with a proven ability to ensure compliance across clinical programs.
• Deep organizational and prioritization skills with keen attention to detail in a fast-paced environment.
• Excellent written, verbal, and presentation skills, with the ability to communicate complex clinical strategies effectively.
• Demonstrated leadership and project management expertise, with a track record of driving cross-functional collaboration and delivering results.
• Proven ability to manage multiple projects simultaneously, balancing strategic oversight with hands-on execution.
• Strong interpersonal and stakeholder management skills, with the ability to engage effectively across all levels of an organization and with external partners.

 

Education:

• Bachelor's degree in a scientific or health-related field is required. Advanced degree in a scientific or health-related field is preferred.

Benefits of Working at Kailera

In addition to traditional benefits, we provide enhanced offerings designed to support the well-being and financial security of our team members and their families.

• Comprehensive health benefits and tax-advantaged savings accounts
• Flexible time off, 13 paid holidays, and a companywide year