Senior Medical Director, Clinical Development

Kailera Therapeutics•Waltham, MA

5d•Hybrid

About The Position

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. We are seeking an experienced, highly motivated Senior Medical Director, Clinical Development to join our growing team. This individual will play a pivotal role in designing and executing clinical development programs that advance our pipeline of innovative therapeutics. The successful candidate will bring strong clinical insight, a deep understanding of drug development in a biotech setting, and a proven ability to work cross-functionally in a dynamic, fast-paced environment. Required location: Waltham, MA (hub-based, onsite 3-4 days per week)

Requirements

4+ years of industry experience in clinical development, preferably in a biotech or small pharma environment
Hands-on experience designing and executing clinical trials
Understanding of GCP, clinical trial design, regulatory requirements, and safety monitoring
Excellent written and verbal communication skills, including protocol and regulatory document writing
Demonstrated ability to engage with KOLs, investigators, and cross-functional teams
Can work independently; self-starter attitude
Advanced PowerPoint skills; working knowledge of Excel and other commonly used clinical systems/tools
Ability to manage multiple studies and deadlines in a fast-paced environment
Must be exceptionally detail oriented

Nice To Haves

Experience in cardiometabolic therapeutic area is advantageous
Proven track record of contributing to IND submissions and global regulatory filings is a strong plus

Responsibilities

Responsible for medical monitoring/reporting and safety activities
Provide strategic medical leadership in the design, planning, and execution of clinical development strategies across multiple studies
Acts as the medical contact at the company for clinical/medical issues
Interprets, reports, and prepares oral and written results of product research, in concert with senior clinical personnel
Serves as the medical expert for assigned assets studies
Contribute to regulatory interactions and strategy, including IND/CTA submissions and briefing packages
Collaborate and work closely with Clinical Operations to ensure appropriate site selection, patient recruitment strategies, and high-quality trial execution
Oversee and support data interpretation, analysis, and clinical study reports
Work closely with internal stakeholders, including Regulatory, Safety, CMC, Medical Affairs, and Translational Science teams
Drive partnerships with external collaborators, KOLs, CROs, and investigators
Support scientific publications, conference presentations, and other external communications
Participate in safety review meetings and provide clinical input into adverse event evaluation and reporting