Director, Program Management – Regulatory Submissions

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🔥 18 minutes ago

🍂 Massachusetts – Remote

🍂 Massachusetts – Remote

💵 $192k - $235k / year

⏰ Full Time

🔴 Lead

📋 Program Manager

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Kailera Therapeutics

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2024

💰 $600M Series B - Kailera Therapeutics on 2025-10

Kailera Therapeutics (Kailera) is developing a broad, advanced, and differentiated portfolio of clinical-stage injectable and oral therapies for the treatment of obesity. Kailera’s most advanced program, KAI-9531 (being developed in China as HRS9531), is an injectable GLP-1/GIP receptor dual agonist that demonstrated positive clinical trial results in obesity in China. The Company is also advancing a diversified pipeline leveraging several mechanisms and routes of delivery. Kailera’s mission is to develop next-generation weight management therapies that give people the power to transform their lives and elevate their overall health. The Company is based in Waltham, MA and San Diego, CA. For more information, visit www.kailera.com.

📋 Description

• Collaborate with clinical, regulatory, non-clinical, and technical operations teams • Lead regional and global cross-functional teams in planning, preparing, and delivering compliant marketing authorization filings • Oversee project plans from initiation to completion, ensuring delivery on time, in scope, and within budget • Identify potential risks and implement effective solutions • Lead execution of submission strategies aligned with corporate objectives and regulatory requirements • Lead and manage cross-functional submission team meetings and workstreams across Regulatory, Clinical, Quality, CMC, and Medical Writing • Oversee project team delivery of marketing authorization applications • Develop and own integrated marketing authorization plans covering goals, deliverables, timelines, and resources • Monitor project progress and provide regular updates to the Program Leader and stakeholders • Own program reports and dashboards for executive and governance teams • Establish best practices and SOPs for marketing application submission processes

🎯 Requirements

• 10+ years of relevant 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, organizational, attention-to-detail, and analytical skills • Ability to manage multiple priorities in a fast-paced, dynamic environment • Comfortable navigating ambiguity and driving clarity • Ability to maintain composure, resilience, and an open mind while embracing change • Proven record of collaboration and excellent communication • Proficiency in project management tools such as Smartsheet, MS Project, Excel, think-cell, and OnePager • Bachelor’s degree in science, engineering, or a related field; advanced degree preferred • Employment eligibility verification through E-Verify

🏖️ Benefits

• Comprehensive health coverage • Flexible time off • Paid holidays • Year-end shutdown • Monthly wellness stipend • Generous 401(k) match • Tuition reimbursement • Commuter benefits • Disability and life insurance • Annual bonus opportunities • Equity grants

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