Vice President – CMC

This is a fully remote position, open to applicants in United States, +1 more state.

📋 Description

• Take charge of CMC oversight for all active assets, including drug substance and drug product, analytics, stability, comparability, supply, quality, GMP ownership, QP release, and the CMC sections of regulatory submissions. Ensure that every program remains on schedule and within budget, while integrating CMC considerations into clinical development planning.

• Identify, contract, and oversee CDMOs, testing laboratories, and other suppliers, ensuring adherence to timelines, quality standards, and budget constraints. This is a fundamental aspect of the role, not a secondary task.

• Assess and mitigate the CMC risks associated with inherited and in-licensed candidate assets, highlighting any manufacturing complexities or costs that could render an otherwise appealing asset uneconomical, and pinpointing formulation choices that enhance protectable IP value.

• Develop and maintain a network of CMC key opinion leaders (KOLs) and consultants, while assisting regulatory and clinical teams with CMC content for interactions with the FDA and other regulatory agencies.

⛳️ Requirements

• A minimum of 10 years in CMC or pharmaceutical development, with at least the last 3-4 years in a role responsible for CMC management for one or more programs; we value the substance of your experience over the specific title held.

• Experience in personally managing 3 or more CDMOs or external manufacturing partners during clinical development, including tech transfer, scale-up, and supply of both drug substance and drug product for clinical trials. Experience in selecting and contracting new CDMOs, rather than just managing existing ones, is a significant advantage. Tech transfer experience from non-US to US manufacturers is especially beneficial given our portfolio.

• Responsibility for the CMC content of regulatory submissions; authored or led the CMC sections (Module 3) for multiple INDs, and ideally contributed to at least one NDA/BLA or major amendment. While deep process-validation and commercial-launch experience is appreciated, it is not mandatory given our exit-before-commercialization model.

• Most of our current portfolio is in Phase I and II, so experience in these stages is prioritized over late-stage or commercial experience.

• CMC experience across multiple modalities (both small molecules and biologics preferred, covering drug substance and drug product), or a proven ability to quickly adapt to a new modality with expert support.

• Capability to assess assets from third parties and promptly evaluate the state, gaps, and risks of an inherited CMC package.

• Strong judgment on what constitutes "good enough" CMC at each stage, ensuring that effort is aligned with the value-inflection point instead of a commercial launch that we won't manage ourselves.

• Ability to operate effectively without a direct-report team, managing scope and delivery solely through external consultants, CDMOs, and KOLs.

• A self-starter with a proactive approach.

• A passion for our mission of transforming the healthcare industry and innovating new health treatments.

• An eagerness to experience life in a rapidly growing, mission-driven, VC-funded startup environment.

🏝️ Benefits

• Competitive salary, along with substantial stock options.

• 27 days of annual leave, in addition to 11 National Holidays.

• Health insurance coverage through our PEO, Trinet.

• A $40 monthly wellness allowance, which can be used for a wellhub membership or wellness-related activities and expenses of your choice!

• Enhanced Parental Leave: 16 weeks of full pay for the primary caregiver and 6 weeks of full pay for the secondary caregiver.

• An annual Learning and Development allowance of $2,000 for courses, certifications, and professional growth.

• Regular company-wide and team events, both in-person and virtual.

• Access to gym and retail discounts through our benefits platform, Happl.

• Monthly lunch vouchers for our remote teams.

• Opportunities for charity events and fundraising through our partnership with the Forward Trust.