Associate Director/Director, Program Management (Regulatory Submissions)

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.

What You’ll Do:

The Associate Director/Director, Program Management 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.

Required location: Waltham, MA (hub-based, onsite 3-4 days per week)

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 inate-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
  • Associate Director: advanced degree 5 years of experience
  • Director: advanced degree 8 years of experience

This role may be hired at the Associate Director or Director level depending on candidate experience or business need.

For Full Time Roles: This range represents the company’s good-faith estimate of the salary at the time of posting. Actual pay may vary based on experience, skills, qualifications, location, and internal equity. We also offer comprehensive health coverage, flexible time off, paid holidays, and a year-end shutdown. Enjoy a monthly wellness stipend, generous 401(k) match, tuition reimbursement, commuter benefits, disability and life insurance, plus annual bonus opportunities and equity grants—because your well-being and future matter to us.

EQUAL EMPLOYMENT OPPORTUNITY INFORMATION: 

Kailera Therapeutics, Inc. is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race (including traits historically associated with race, such as hair texture and protective hairstyles), color, creed, religion (including religious dress and grooming practices), national origin, ancestry, citizenship status, age (40 and over), sex or gender (including pregnancy, childbirth, pregnancy-related conditions, and lactation), gender identity or expression (including transgender status), sexual orientation, marital status, military service and veteran status, physical or mental disability, genetic information, reproductive health decisions, domestic victim status, political affiliation, or any other characteristic protected by applicable federal, state, or local laws and ordinances.

E-Verify:

Kailera Therapeutics, Inc. uses E-Verify to confirm the identity and employment eligibility of all new hires.

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