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Senior Director, Regulatory CMC

Centessa Pharmaceuticals · Boston, MA · On-site

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About Centessa Pharmaceuticals

Patient-Centric Mission. Asset-Centric Approach. We’re pursuing our Orexin Receptor 2 Agonist Program to bring potentially transformative treatment options to patients with sleep-wake, neurological, neurodegenerative and neuropsychiatric disorders.... Backed by Foresite Capital.

About the role

Centessa Pharmaceuticals, a wholly owned subsidiary of Eli Lilly and Company, is a clinical-stage company developing orexin receptor 2 (OX2R) agonists as a new class of medicines for the treatment of narcolepsy and potentially other sleep-wake disorders. Centessa’s lead investigational candidate – cleminorexton (formerly ORX750) – is being developed for narcolepsy type 1, narcolepsy type 2, and idiopathic hypersomnia. Found on 1752vc Careers, the job board for startup and VC roles.

What they're looking for

  • Master's degree in Chemistry, Pharmaceutical Sciences, or a related scientific discipline required, PharmD or PhD preferred
  • Minimum of 12 years of pharmaceutical industry experience, including at least 5 years in Regulatory CMC roles supporting small molecule development programs
  • Recent, direct experience leading Regulatory CMC activities for late-stage development programs, including NDA-enabling activities and marketing application submissions, is required
  • Proven experience authoring, reviewing, and managing CMC regulatory filings, including INDs, IMPDs, NDAs, and global health authority interactions
  • Strong knowledge of small molecule drug substance and drug product development, analytical development, manufacturing processes, control strategies, and pharmaceutical development principles
  • Extensive experience managing CDMOs and external development and manufacturing organizations
More about this role

Centessa Pharmaceuticals, a wholly owned subsidiary of Eli Lilly and Company, is a clinical-stage company developing orexin receptor 2 (OX2R) agonists as a new class of medicines for the treatment of narcolepsy and potentially other sleep-wake disorders. Centessa’s lead investigational candidate – cleminorexton (formerly ORX750) – is being developed for narcolepsy type 1, narcolepsy type 2, and idiopathic hypersomnia. Centessa's OX2R agonist portfolio includes additional clinical and preclinical-stage assets with potential utility across a broader range of neurological, neurodegenerative, and neuropsychiatric conditions.

Headquartered in Boston, Massachusetts, Centessa was recognized as a Great Place to Work ® in 2026.

As the Senior Director, Regulatory CMC, you will provide strategic and operational leadership for Regulatory CMC activities across the company's small molecule development programs. Reporting to the Executive Director, Regulatory CMC, you will lead Regulatory CMC initiatives, develop and execute global CMC regulatory strategies, partner with internal and external stakeholders, and oversee CMC regulatory submissions across our portfolio.

The ideal candidate brings...

Read the full posting on Centessa Pharmaceuticals's site ↗

Regulatory

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