Vice President, CMC Development and Drug Delivery Innovation (Fully Remote)

Kailera Therapeutics; United States; Remote; USD 180,000 - 260,000; Full time

Job summary

Kailera Therapeutics seeks a senior leader to own CMC strategy and execution across our portfolio, including drug substance, drug product, and device/combination products.

You will lead process development, scale-up, technology transfer, and regulatory submissions for CMC and device sections to support global filings, while building a high-performing CMC and device engineering organization in partnership with Regulatory, Quality, Clinical, and Commercial teams.

Job description

• Own CMC strategy and execution across the full portfolio, spanning drug substance, drug product, device/combination products, and oral solid dose formulations.
• Lead process development, scale-up, technology transfer, and regulatory submissions for CMC and device sections to support global filings.
• Build and mentor a high-performing CMC and device engineering organization while partnering cross-functionally with Regulatory, Quality, Clinical, and Commercial teams.