---
title: 'Associate Director, CMC Operations at Kailera Therapeutics, Inc.'
canonical: 'https://feeny.ai/job/associate-director-cmc-operations-kailera-therapeutics-inc-united-states-39cdrzcbwtbm'
type: 'job'
last_seen: '2026-11-07'
---

# Associate Director, CMC Operations at Kailera Therapeutics, Inc.

- **Company:** Kailera Therapeutics, Inc.
- **Location:** United States
- **Compensation:** $155k–$190k
- **Work type:** remote
- **Posted:** 2026-10-19
- **Last confirmed live:** 2026-11-07
- **Apply:** https://job-boards.greenhouse.io/kailera/jobs/5457665008

## Job description

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:

Reporting to the Vice President, Technical Operations Portfolio Management, the Associate Director, CMC Operations will drive the planning and execution of Kailera’s programs, spanning technical development, CDMO partnerships, technology transfers, clinical and commercial manufacturing, and preparation of regulatory submissions. In partnership with Technical Operations core team representatives, the individual will support cross-functional Technical Operations Program Teams, build and maintain integrated CMC timelines, and manage risks, dependencies, and decisions across Kailera’s multiple development programs. The Associate Director will also support the preparation, forecasting, and monitoring of departmental budgets.

Required location: Waltham, MA (hub-based, onsite 3-4 days per week) OR Remote (home-based, onsite at a hub 1 week every other month).

Responsibilities:

- Lead planning and execution of CMC workstreams across multiple development programs, from technical development through regulatory submission and product approval
- Build and maintain integrated CMC project plans and timelines in Smartsheet, aligning drug substance, drug product, analytical, packaging, and supply activities with clinical and regulatory milestones
- Lead and/or facilitate cross-functional Technical Operations Program Teams: set agendas, drive decisions, track action items, risks, and issues to resolution
- Coordinate activities with CDMO partners, including technology transfers and manufacturing campaigns, tracking deliverables against contracted scope and timelines
- Identify, assess, and mitigate project risks and critical-path dependencies, and develop contingency plans where needed
- Coordinate CMC contributions to regulatory submissions, tracking authoring, review, and approval timelines
- Work closely with Technical Operations team, Quality, Regulatory, Clinical Supply, and Finance colleagues to maintain highly efficient practices for pharmaceutical product development and budget management
- Proactively communicate project status, key issues, and other critical topics in a timely manner to the appropriate management level and relevant project team members, including through dashboards and governance updates
- Ensure quality, scope, and timelines are met across all assigned projects, and keep team members updated on target dates and priorities
- Support departmental budget planning, forecasting, and expense tracking in partnership with Finance
- Drive continuous improvement of CMC project management tools, templates, and processes

Required Qualifications:

- 10+ years of experience in pharmaceutical drug development, including 5+ years in CMC project management or a related program management role
- Working knowledge of CMC development, technology transfer, and clinical and/or commercial manufacturing, including experience managing work with CDMOs
- Track record of success managing multiple projects or programs simultaneously
- Advanced proficiency in Smartsheet, with experience building integrated timelines and dashboards
- Experience with project budgets, forecasting, and expense tracking
- Excellent communication, facilitation, and presentation skills, including with senior leadership
- Proven track record of creativity, problem solving, and productivity, particularly when no or minimal precedent is in place
- Demonstrated successful experience working in interdisciplinary and cross-cultural teams

Preferred Qualifications:

- PMP or equivalent project management certification
- Experience supporting late-stage development and marketing application submissions (e.g., NDA Module 3)

Education:

- Bachelor’s degree in a scientific discipline preferred; advanced degree a plus

Salary Range $155,000—$190,000 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. 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.

#LI-Hybrid

## About Kailera Therapeutics, Inc.

## Company Overview
- **One-liner**: Kailera Therapeutics is an advanced clinical-stage biotechnology company developing a diversified pipeline of GLP-1‑based therapies for obesity and overweight.
- **Entity Type**: Private (clinical stage; in‑licensed through a strategic collaboration with Jiangsu Hengrui Pharmaceuticals)
- **Headquarters**: Waltham, Massachusetts, United States
- **Founded**: Not publicly available
- **Founders**: Not publicly available

## Core Business
- **Primary industries**: Biotechnology / Obesity therapeutics
- **Target customers**: B2B (pharma partnerships) and ultimately patients and healthcare providers managing obesity and overweight
- **Mission**: To give people the power to restore their health and transform their lives by delivering category‑leading obesity management medications. [kailera.com/about-us](https://www.kailera.com/about-us/)

## Products & Services
Kailera’s pipeline is designed to address diverse unmet needs in obesity care, building on clinical data from Hengrui’s trials in China. All candidates are in‑licensed from Hengrui with exclusive rights outside China, Hong Kong, Macau and Taiwan.

- **Ribupatide (KAI‑9531)** – Once‑weekly injectable GLP‑1/GIP receptor dual agonist peptide; currently in a global Phase 3 program.
- **Ribupatide oral tablet** – Once‑daily oral formulation of the dual agonist.
- **KAI‑7535** – Oral small‑molecule GLP‑1 receptor agonist (clinical stage).
- **KAI‑4729** – Once‑weekly injectable GLP‑1/GIP/glucagon receptor tri‑agonist (clinical stage).

## Market Standing
- **Valuation / Market Cap**: Not disclosed (private company)
- **Key Metric**: Total funding – not publicly available; revenue – none (pre‑commercial). Pipeline lead in Phase 3.
- **Notable Investors / Partners**: Jiangsu Hengrui Pharmaceuticals Co., Ltd. (strategic collaboration and in‑licensing partner). Leadership team includes veterans from Cerevel Therapeutics, Translate Bio, Bain Capital Life Sciences, Amgen, Frazier Life Sciences, and AbbVie. [kailera.com/leadership](https://www.kailera.com/leadership/)
- **Growth Signals**:
  - Ribupatide clinical data presented at the American Diabetes Association (ADA) 2026.
  - Global Phase 3 program underway for ribupatide.
  - Multiple clinical‑stage candidates (oral, small molecule, tri‑agonist) targeting different patient needs.
  - Active hiring with 29 open positions (as of mid‑2026) across R&D, clinical, supply chain, regulatory, and corporate functions. [job-boards.greenhouse.io/kailera](http://job-boards.greenhouse.io/kailera)

## Competitive Advantages
- **Diversified modality pipeline**: Injectable dual agonist, oral formulation, oral small molecule, and tri‑agonist – covering a broad range of patient preferences and treatment stages.
- **Cross‑border development acceleration**: Access to Hengrui’s clinical data from China informs and de‑risks global trials.
- **World‑class leadership**: CEO Ron Renaud (former CEO of Cerevel and Translate Bio, both acquired by AbbVie and Sanofi respectively). CMO Scott Wasserman, M.D. (former CEO of Latigo Biotherapeutics, former Amgen VP leading metabolic and cardiovascular portfolios). Commercial and operational executives from top pharma. [kailera.com/leadership](https://www.kailera.com/leadership/)
- **Obesity‑first focus**: Pipeline deliberately built for the chronic, progressive nature of obesity, aiming to address the gap for greater weight loss and higher‑BMI patients.

## Strategic Focus
Kailera’s immediate priority is advancing ribupatide through Phase 3 to regulatory submission while progressing the earlier‑stage oral and tri‑agonist programs. The company aims to “elevate the next era of obesity care” by delivering multiple options for patients no matter where they are in their treatment journey. [kailera.com/](https://www.kailera.com/)

## Why Work Here
- **Culture (“Kai Values”)**: Emphasizes courage, collaboration, compassion, and commitment. The team operates with entrepreneurial spirit, transparency, and a patient‑centered mission. [kailera.com/join-our-team](https://www.kailera.com/join-our-team/)
- **Work Model**: Hybrid and remote options available – many roles are based in Waltham, MA, but some (e.g., Statistical Programming, Clinical Quality Assurance) are listed as US‑Remote.
- **Notable Perks**: Purpose‑driven work in a fast‑growing therapeutic area; opportunity to work with top industry veterans; exposure to a pipeline that spans multiple cutting‑edge modalities (injectable, oral, small molecule).
- **Growth Opportunity**: With 29 open positions across all levels (Associate Director to Senior Director), the company is scaling rapidly, offering significant career advancement in a high‑impact field.

## Sources
1. [kailera.com](https://www.kailera.com/)
2. [kailera.com/about-us](https://www.kailera.com/about-us/)
3. [kailera.com/leadership](https://www.kailera.com/leadership/)
4. [kailera.com/join-our-team](https://www.kailera.com/join-our-team/)
5. [job-boards.greenhouse.io/kailera](http://job-boards.greenhouse.io/kailera)

## Other roles at Kailera Therapeutics, Inc.

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