Associate Director, Clinical Scientist

Kailera Therapeutics•Waltham, MA

2d•Hybrid

About The Position

The Associate Director, Clinical Scientist will play a key role in Kailera’s research and development organization, with hands-on scientific responsibility for clinical trial execution and delivery. The role supports a Phase 3 pivotal study planned for NDA submission and requires working at both study-team and leadership levels to lead day-to-day execution, data review, and data analysis. The successful candidate will independently identify and address challenges, work cross-functionally to develop and refine clinical and scientific processes, and take on increasing strategic and leadership responsibilities. The role also involves broad external scientific communication from study start-up through reporting in support of Kailera’s growing development portfolio. The position is hub-based in Waltham, Massachusetts, with onsite work required 3–4 days per week. The Associate Director will work with the Clinical Science Asset Lead and key R&D stakeholders, support Medical Directors on one or more Phase I–III studies, and contribute to clinical strategy and study deliverables.

Requirements

At least 5 years of extensive hands-on experience supporting clinical trials in a clinical development role.
Experience representing technical expertise on study teams and collaborating with colleagues to achieve milestones and goals.
Experience reviewing and interpreting clinical trial data listings.
Strong understanding of clinical trial conduct and cross-functional trial workflows.
Ability to work independently and navigate leadership demands while directing the broader study team in partnership with Clinical Operations.
Exceptional organizational, prioritization, leadership, and execution skills.
Strong cross-functional communication skills.
Ability to manage multiple studies and deadlines in a fast-paced environment.
Ability to act as the subject matter expert for a cross-functional study team and contribute to development strategy as part of a broader team.
Thorough understanding of the drug development process from IND/CTA through BLA/NDA submission.
Broad understanding of drug development functions, including preclinical, regulatory, pharmacovigilance, drug supply, data sciences (Data Management, Biostatistics, and Programming), and Clinical Operations (including site selection, study start-up, study conduct, and finalization).
Ability to understand, interpret, and communicate clinical information, including literature reviews, competitive intelligence, and changing treatment paradigms.
RN, MS, PhD, or PharmD, or equivalent, with clinical research experience.

Nice To Haves

Advanced degree and/or professional certification or credentials.

Responsibilities

Support 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 efficacy and safety endpoint objectives of clinical trials.
Identify and provide solutions to data trends, inconsistencies, and potential issues in partnership with Data Management, Biostatistics, and Safety.
Collaborate with cross-functional teams, including Clinical Operations, Data Management, Biostatistics, Programming, Safety, and Regulatory.
Provide clinical oversight of study execution 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 or incorporated into clinical trial development strategy.
Contribute to the development and standardization of templates, processes, infrastructure, and procedures supporting clinical development.
Travel as needed and attend site-related clinical development activities; form and maintain relationships with KOLs.