Project Management Consulting Experience
More than 20 years of project and program management experience in the Chemical and Pharmaceutical industries across:
1. All stages of pharmaceutical development from Pre-IND through Commercial process improvements,
2. All organizational sizes from start-up and emerging companies to large pharma
3. Multiple modalities including small molecules, biologics, combination (device) products, whole cells, and antibody-drug conjugates
4. All functional areas
5. Many indications
Project experience sorted by Development Phase is included below.
Pre-Clinical / Phase 1 including IND Prep
Led IND-enabling and early clinical development for multiple programs including biologics, small molecules, and combination products. Managed CMC, regulatory, and supply planning for rare disease, infectious disease, oncology, CNS, and animal health indications. Supported clients from candidate selection through IND prep and submission, early Phase 1 trials, and strategic funding proposals (e.g., BARDA, SBIR). Delivered planning tools, project templates, and cross-functional coordination for companies ranging from 4-person startups to global pharma.
Phase 2 / 3 including NDA Prep
Provided program leadership through advanced clinical development and NDA readiness for small molecules, biologics, and combination products. Managed cross-functional teams to address clinical holds, FDA responses, supply chain strategy, and process validation. Supported programs across ophthalmology, oncology, nephrology, diabetes, and biodefense. Successfully led regulatory submissions, Phase 3 preparation, and coordinated on-time delivery of NDA components.
Commercial / Other Related Experience
Oversaw commercial supply projects, process improvements, and regulatory commitments for marketed biologics and PEGylation products. Led cross-functional teams in engineering, tech ops, and quality to address FDA findings and drive operational efficiency. Established and ran a Stage-Gate PMO for new product development, doubling new product revenue. Experience spans biotech, pharma, and specialty chemical industries.