The Convergence Engine for Drug Development
Architecting the operational blueprint that transforms therapeutic visions into IND-ready assets. Bridging from lead candidate optimization to regulatory submission, I integrate CMC, preclinical, and translational functions into a unified execution strategy.
Distinctive operational backbone services through Advisory, Consulting or Fractional Leadership to help innovators operationalize their vision, afforded by a career arc over two and a half decades working within large-scale matrix leadership to hands-on R&D Operations integration
My approach is grounded in the belief that integration drives velocity. When candidate optimization, efficient preclinical and CMC strategy and regulatory planning converge into a unified workplan, development timelines compress and execution risk is managed effectively.
This is how we build biotech companies that matter.
Former: Paragon Therapeutics • Deciphera Pharmaceuticals • Janssen R&D
Integration Architecture
Multiple scientific disciplines converge into a single executable focal point.
Asset discovery & Optimization
Multi-specific biologics, ADCs, or small molecules engineered for developability. Guiding discovery principles to enable efficient progression through preclinical and clinical development
CMC Strategy
Integrated CMC development workplan encompassing from small scale to GMP production. CDMO selection & partnership, process development, analytical methods, regulatory CMC documentation
Preclinical Execution
IND-enabling studies designed with manufacturing constraints. DMPK, toxicology, translational biomarkers. FIH-readiness as unified deliverable
Regulatory Pathway
FDA/EMA strategy, IND preparation, breakthrough designation pursuit. Cross-functional team leadership toward submission milestones
IND-Ready Asset
Fully integrated development package positioned for clinical entry and Series A fundraising
Strategic Engagement Models
NewCo Incubation
Corporate structure design using the Roivant/Paragon blueprint for optimized Seed and Series A fundraising pathways.
- C-suite coaching and development team assembly
- Investor presentation and data room preparation
- Capital-efficient operating model design
- Strategic milestone planning (Seed → Series A → IND)
Integrated CMC & Preclinical Development
Unified workplan from developability assessment through IND submission, where CMC and preclinical strategies inform each other.
- CMC roadmap: Bridging leadop/discovery to developability, cell line development to formulation/process development to GMP manufacturing for FIH and beyond
- IND-enabling study design (translational, disease animal models, DMPK, tox)
- Strategic CDMO/CRO MSA-governed agreements
- FIH-readiness as integrated deliverable
R&D Operations & Program Leadership
Cross-functional team integration and program management infrastructure for lean, capital-efficient biotech operations
- Global program matrix team leadership
- Regulatory pathway strategy (FDA, EMA)
- Alliance and partnership management
- Budget management and resource allocation
- Risk mitigation and contingency planning
Execution History
2x NewCo, Inc. Stealth (Immunology & Inflammation)
Incubated and launched two NewCo targeting atopic diseases with de-novo multi-specific HLE-extended and Fc-engineered antibodies. Coached investment team in end-to-end corporate design, equity structure and integrated R&D Operations functions. Spearheaded CMC workplan to FIH readiness and translational/tox IND-enabling studies. Major MSA-governed collaborations with leadings CDMOs were established (Adimab, RoukenBio, ChemPartner, WuxiBio, PharmaLegacy, WuxiAppTec, Charles River).
Paragon Therapeutics
Reporting to the Chief Operating Officer, responsible for strategic and operational leadership for preclinical development across an extensive portfolio of best-in-class biologics. Led integration of all preclinical IND-enabling studies to a CMC accelerated workplan for three successful spin-offs, each raising $200M+ in Series A funding and advancing to clinical development.
Seeker Biologics, a 5AM Ventures Company
Reporting to the Chief Scientific Officer, led the program management function across the portfolio of innovative de novo discovered multi-specific biologics (scFv, VHH) with minimized cytotoxicity and increased selectivity to address significant medical need primarily in immune-mediated diseases and oncology
Deciphera Pharmaceuticals
Reporting to the Chief Technology Officer, with point accountability for entire portfolio, drove Qinlock® to global approval in 4.5 years (Phase 1 → approval) and led CMC team for Romvimza® (vimseltinib) FDA approval.
Janssen R&D (Johnson & Johnson)
Total project champion/matrix CMC leader role for all development activities (NME declaration to commercialization). Led 20+ CMC programs (small molecules + biologics) from NME to approval. Extended leading role in Licensing & Acquisitions/Divestitures and Strategic Alliances. Managed global alliances including Gates Foundation/DNDi ($10M+ annual budget) and TESARO ($15M budget).
Collaborator Network
I bring together a curated network of subject matter experts to compliment the core offering in CMC, preclinical and program leadership, to ensure delivery of a holistic solution. This modular approach ensures you have the exact expertise needed at each development stage.
Advisor / Collaborator profiles will be shared upon request and based on specific project needs. Engagements will be managed centrally with proper consent and formal agreements
Specialized expertise in translational models, biomarker strategies, DMPK, toxicology, regulatory and other specialized scientific domains
Flexible engagement model: bring in specialists as needed for your specific development challenges.
Let's Build Something
Whether you're forming a NewCo, advancing a therapeutic candidate, or need strategic guidance on integrated development operations, let's discuss how convergence thinking can accelerate your program.