Kailera Therapeutics, Inc.

Associate Director/Director, Program Management (Regulatory Submissions)

Remote - US · Director · Full-time

Sponsorship not specified$155k-$190kDetected 5 days ago

Project ManagementExcelRecruitingCommunicationCollaborationProblem SolvingOrganizational Skills

About the role

As we expand, we seek the most talented individuals with diverse backgrounds, cultures, perspectives, and experiences to join our team.
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.
Actual pay may vary based on experience, skills, qualifications, location, and internal equity.

Additionally, they will work closely with teams to proactively identify potential risks and implement effective solutions.
Contribute to and lead the execution of submission strategies in alignment with corporate objectives and regulatory requirements
Develop and own detailed integrated marketing authorization plans, including goals, deliverables, timelines, and resource requirements
Own program reports / dashboards to executive and other governance teams
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.

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
Proven record of collaboration and excellent communication
Associate Director: advanced degree 5+ years of experience
Director: advanced degree 8+ years of experience
advanced degree 8+ years of experience

Bachelor's degree in science, engineering, or a related field
advanced degree preferred
Experience in managing cross-functional teams and complex projects inate-stage drug development, with experience managing global marketing authorization submissions (NDA, BLA, MAA) preferred

$155,000 - $190,000 USD
Salary Range (Associate Director)
Salary Range (Director)
$192,000 - $235,000 USD
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.
This range represents the company's good-faith estimate of the salary at the time of posting.

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 also offer comprehensive health coverage, flexible time off, paid holidays, and a year-end shutdown.
Lead and manage cross-functional submission team meetings and workstreams (Regulatory, Clinical, Quality, CMC, Medical Writing)

We are passionate about creating an inclusive workplace that promotes collaboration, integrity, and excellence.

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

tive 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-rel

This listing is sourced directly from Kailera Therapeutics, Inc.'s careers page and normalized into a canonical job model.