The Convergence Engine for Drug Development
I turn therapeutic ideas into clinical programs via the shortest defensible and fundable path. I step into the next constraint facing a company. I've owned both ends of the development path: discovery through FIH, and Phase 3 to global approval. That range is why the early decisions are defensible — I know what the plan has to survive.
My role is to connect the decisions that are often made in isolation, biologics discovery and engineering, preclinical, translational, CMC, regulatory and capital strategy and turn them into a coherent, executable development plan.
I operate across Advisory, Consulting and Fractional embedded leadership, afforded by a career arc over two and a half decades working within large-scale matrix leadership to hands-on R&D Operations integration
Most often lean teams don't fail on science. They fail on sequencing, and on discovering too late what the plan assumed. I own decisions and timelines, and give a non-diluted view of the risks, costed out at each inflection point. Accelerate with intent on first principles; hold steady when risk overruns enthusiasm.
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 and 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 to FIH-readiness as a unified deliverable designed with manufacturing constraints. Incorporating DMPK, toxicology, translational expertise as appropriate
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 lead-op/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 (2) NewCos 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 partnerships with leading CDMOs were established (Adimab, 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 spin-offs, now in clinical development with robust and potentially best-in-class data, each backed by initial $200M+ private placements.
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) from DC to Phase 2.
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.
Start a conversation
If you're forming a NewCo, resourcing a program toward IND, or looking at a portfolio company that needs development leadership it can't yet carry — I'd welcome twenty minutes.