What are the responsibilities and job description for the Senior Director, Clinical Operations position at Kailera Therapeutics, Inc.?
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 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 Senior 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 :
- Lead clinical trial management, budgeting, and resourcing strategy at the clinical program level as the Clinical Operations Program Lead.
- Partner with the SVP, Clinical Development Operations to align resources and budgets across clinical programs, evaluating timelines and prioritizing tasks effectively.
- Provide strategic leadership to clinical project teams, ensuring alignment with program and corporate objectives.
- Deliver clinical program updates (e.g., trial status, key metrics, budget, accomplishments, and risks) to SVP Development Operations, Program Leaders, and Senior Management.
- Drive continuous improvement initiatives, contributing to the development of SOPs, Work Instructions (WIs), training programs, and compliance tools to ensure adherence to FDA regulations.
- Oversee and support trial management activities, including budget oversight, study execution, CRO / vendor management, risk mitigation, and compliance with GCP.
- Develop and implement clinical trial monitoring strategies, ensuring quality and compliance across studies.
- Lead the selection and oversight of external strategic partners, ensuring alignment with clinical program needs.
- Develop, implement, and manage innovative clinical trial monitoring approaches to enhance operational efficiency and data integrity.
- Oversee the development and maintenance of clinical monitoring SOPs, tools, and templates (e.g., monitoring plans, visit report templates).
- Collaborate with Quality Assurance to address systemic issues identified in audits of external service providers and clinical sites.
Required Qualifications :
Education :
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.
At Kailera, we are committed to fostering an inclusive culture. How we treat our people is reflective of this commitment. We share the pay range for this particular role with the actual base salary depending upon factors such as job-related knowledge, skills, market factors, and experience.
Salary Range
210,000-$270,000 USD
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
Salary : $210,000 - $270,000
