Director, Program Management Regulatory Submissions
Kailera Therapeutics, Inc.
Summary
The Director, Program Management Regulatory Submissions will collaborate with cross-functional teams, including clinical, regulatory, non-clinical, and technical operations, to lead regional and global cross-functional teams in the planning, preparation, and delivery of compliant marketing authorization filings. This individual will oversee the development and execution of project plans from initiation to completion, ensuring the plan is completed on time, in scope, and within budget. Additionally, they will work closely with teams to proactively identify potential risks and implement effective solutions. A successful candidate must have experience managing drug development projects, particularly initial marketing authorization applications, in a fast-paced environment, with a strong willingness to build relationships with cross-functional teams, dive into details, and address gaps as needed to ensure program success.
Job description
Responsibilities
- Contribute to and lead the execution of submission strategies in alignment with corporate objectives and regulatory requirements
- Lead and manage cross-functional submission team meetings and workstreams (Regulatory, Clinical, Quality, CMC, Medical Writing)
- Oversee project team delivery of the marketing authorization applications
- Develop and own detailed integrated marketing authorization plans, including goals, deliverables, timelines, and resource requirements
- Monitor project progress and provide regular updates to Program Leader and other stakeholders, ensuring clear communication and transparency
- Own program reports / dashboards to executive and other governance teams
- Establish best practices and SOPs as needed for marketing application related submission processes
Required Qualifications
- 10+ years of relevant experience of project management experience in the biotech, pharmaceutical, or life sciences industry
- Strong understanding of drug development and how biotech functions integrate
- Experience in managing cross-functional teams and complex projects in late-stage drug development, with experience managing global marketing authorization submissions (NDA, BLA, MAA) preferred
- Demonstrated project management and interpersonal skills
- Excellent problem-solving and organizational skills, attention to detail, and analytical skills
- Ability to manage multiple priorities in a fast-paced, dynamic environment
- Comfortable navigating ambiguity and driving clarity
- Responds to changing priorities and uncertainty by maintaining composure, resilience, and an open mind while embracing change in an evolving environment
- Proven record of collaboration and excellent communication
- Proficient in project management tools (e.g., Smartsheet, MS Project, Excel, think-cell, OnePager)
Education
- Bachelor's degree in science, engineering, or a related field; advanced degree preferred
Requirements
- 10+ years of project management experience in the biotech, pharmaceutical, or life sciences industry
- Strong understanding of drug development and how biotech functions integrate
- Experience managing cross-functional teams and complex projects in late-stage drug development
- Experience managing global marketing authorization submissions (NDA, BLA, MAA) preferred
- Demonstrated project management and interpersonal skills
- Excellent problem-solving and organizational skills, attention to detail, and analytical skills
- Ability to manage multiple priorities in a fast-paced, dynamic environment
- Comfortable navigating ambiguity and driving clarity
- Proven record of collaboration and excellent communication
- Proficient in project management tools (e.g., Smartsheet, MS Project, Excel, think-cell, OnePager)
- Bachelor's degree in science, engineering, or a related field; advanced degree preferred
Benefits
- Health coverage
- Flexible time off
- Paid holidays
- Year-end shutdown
- Monthly wellness stipend
- 401(k) match
- Tuition reimbursement
- Commuter benefits
- Disability insurance
- Life insurance
- Annual bonus
- Equity grants
Company overview
Kailera Therapeutics is a clinical-stage biopharmaceutical company focused on developing next-generation therapies for obesity and related metabolic conditions. Founded in 2024 and headquartered in Waltham, Massachusetts with additional operations in San Diego, California, the company has rapidly established itself as a significant player in the obesity treatment space. Kailera's portfolio includes a broad range of clinical-stage injectable and oral therapies, with its lead program KAI-9531 being an injectable GLP-1/GIP receptor dual agonist that has demonstrated promising results in Phase 3 clinical trials in China. The company's pipeline also features KAI-7535, an oral small molecule GLP-1 receptor agonist, and KAI-4729, an injectable GLP-1/GIP/glucagon receptor tri-agonist. Backed by top-tier healthcare investors including Bain Capital Private Equity, Atlas Venture, and RTW Investments, Kailera has raised substantial funding, including a $600 million Series B financing in 2025. The company is led by an experienced executive team with deep industry expertise and is preparing to initiate global Phase 3 trials for its lead candidate, positioning itself to address one of the most pressing global health challenges.