Lead Clinical Scientist, Phase 3 Trials

Kailera Therapeutics, Inc.; Waltham (MA); On-site; USD 159,000 - 195,000; Full time

Job summary

Kailera Therapeutics, Inc. is seeking an Associate Director, Clinical Scientist to drive day-to-day execution of Phase 3 trials.

You will lead study teams, review data, define efficacy and safety endpoints, and communicate advances to cross-functional partners. The role requires scientific leadership, independent initiative, and strong collaboration across Clinical Operations, Data Management, Biostatistics, and Regulatory.

Qualifications

• 5+ years of hands-on experience supporting clinical trials.
• Experience leading Phase I–III studies.
• Strong ability to interpret clinical trial data listings.
• Excellent cross-functional communication.
• Understanding of IND/CTA through NDA submission.

Responsibilities

• 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.

Skills

Clinical trial experience

Cross-functional collaboration

Data interpretation

Leadership

Project management

Communication skills

Independent work

Time management

Education

RN/MS/PhD/PharmD

Job description

Kailera Therapeutics, Inc. is seeking an Associate Director, Clinical Scientist to drive day-to-day execution of Phase 3 trials.

You will lead study teams, review data, define efficacy and safety endpoints, and communicate advances to cross-functional partners. The role requires scientific leadership, independent initiative, and strong collaboration across Clinical Operations, Data Management, Biostatistics, and Regulatory.