Associate Director, Clinical Scientist

About 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’ll Do:

The Associate Director, Clinical Scientist is a unique opportunity to play a key role in the research and development organization. This role allows for hands-on scientific responsibility of clinical trial execution and delivery. For this role, we are seeking a resourceful and matrixed individual who excels in operating at both the study team and leadership levels to lead in day-to-day execution, data review, and data analysis of the program in support of a Phase 3 pivotal study slated for NDA submission.

This opportunity requires a creative thinker who takes independent initiative to identify and address challenges, while working cross-functionally to drive the development and refinement of clinical and scientific processes and procedures in support of program deliverables.

This individual will assume increasing strategic and leadership responsibilities with broad external scientific communication from study start-up through reporting in support of a growing development portfolio.

Required location: Waltham, MA (hub-based, onsite 3-4 days per week)

Responsibilities:

In cooperation with the Clinical Science Asset Lead and key R&D stakeholders this individual will contribute to clinical strategy with the following expectations:

- Support the Medical Directors for one or more Phase I–III clinical studies

- Lead studies across the full trial lifecycle, from start-up through database lock and reporting

- Provide scientific input to the efficacy and safety endpoint objectives of clinical trials

- Identify and provide solutions to data trends, inconsistencies, and potential issues; partnering with Data Management, Biostatistics, and Safety

- Collaborate effectively with cross-functional teams including Clinical Operations, Data Management, Biostatistics, Programming, Safety, and Regulatory

- Provide clinical oversight of study execution in collaboration with cross-functional teams and ensure alignment with overall clinical strategy in partnership with the Clinical Science Lead for the program

- Author, review, and contribute to trial documents, such as protocols, amendments, Investigator’s Brochures, and Clinical Study Reports

- Develop and deliver clear, well-structured presentations to study teams

- Understand and communicate the disease and treatment landscape to ensure scientific innovations are considered and/or incorporated into clinical trial development strategy