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
Contribute to the development and standardization of templates, processes, infrastructure, and procedures to support clinical development
Be flexible with travel and attend site related clinical development activities; form and maintain relationships with KOL’s
Required Qualifications:
5+ years of extensive hands-on experience supporting clinical trials in a clinical development role
Experience working on study teams representing their technical expertise while working collaboratively with colleagues to achieve milestones and goals
Demonstrates experience reviewing and interpreting clinical trial data listings
Strong understanding of clinical trial conduct and cross-functional trial workflows
Ability to work independently while navigating leadership demands by directing the broader study team in partnership with clinical operations
Exceptional organizational, prioritization, leadership and execution skills
Demonstrates strong ability to communicate cross-functionally
Ability to…