Capabilities
Experience Matters
Put over twenty-five years of functional and cross-functional drug development leadership to work for you
- Experience in large pharma, biotechs and start-ups across multiple therapeutic areas including oncology, rare diseases, women’s health and inflammatory diseases
- Built, developed and led high performing development teams in translational medicine, clinical pharmacology, quantitative bioanalytics, toxicology and clinical development across many asset types such as small molecules, antibodies, siRNA and antibody drug conjugates (ADC)
- Deep hands-on experience preparing for and engaging directly with the FDA and European Health Authorities from pre-IND stage through marketing approval
- Routinely engage on due diligence projects for pharma/biotechs and venture firms
- Operationally oriented – advising executive committees and boards of directors
- Was General Manager of late-stage asset team with >$100M yearly budget reporting to CEO
- Contributed to the development and approval of various marketed products
- Cultivated expansive network of technically focused colleagues – can access resources across wide-range of disciplines
- Coached and mentored staff and colleagues for over 25 years, with formal executive coach training
- Served on editorial board of the Journal of Clinical Pharmacology >17 years
Drug Development and Leadership Strategies
- Strategic preparation for regulatory filings and health authority meetings: including IND, NDA/BLAs, briefing documents and preparation for advisory committee meetings
- Clinical pharmacology program review and development
- Clinical development strategy and advisory board meetings
- Executive and board of directors presentations
- Due diligence projects for pharma/biotechs and venture firms
- Translational medicine/biomarkers/companion diagnostics
- Quantitative bioanalytic approaches for development agents
- Interim leadership of teams while aiding in search for permanent leader
Optimizing Individual and Team Performance
- Individual coaching of professionals into more confident leaders
- Team assessments/builds/rescues
- Change management – moving forward after reorganizations
- Blueprint for progressing - who do you need now vs. later
