IND Filing at a start-up

 Provided senior program management to a biotech start-up to keep their first-in-human solid tumor IND filing on track and on schedule. Established aggressive but achievable milestones, ensured all authors and reviewers had sufficient time allocated, and proactively identified and closed key gaps ahead of submission. The IND was filed on time.

Embedded with a VC-funded biotech to provide expert program oversight for a CMC tech transfer to a new drug product manufacturer. Built internal timelines and dashboards to keep stakeholders aligned, managed all transfer documents with assigned authors and reviewers, and led gap analysis and risk assessment. Coordinated authoring of IND and IMPD amendments for the new site as the transfer reached completion. 

Provided executive-level cross-functional leadership for a small biotech's lead clinical program. Embedded with the internal clinical team to manage program timelines and KPIs, ensured uninterrupted clinical supply chain, and successfully oversaw multiple protocol amendments and IND filings.

Led the effort to bring an asset into a registration study sponsored by an external partner. Built activity trackers covering all contracts, agreements, and clinical protocols; oversaw regulatory document development for an ex-US study; and represented the company's interests directly in partner meetings.