US-based regulatory and quality assurance leader with responsibility for integrated strategic regulatory planning and execution across all programs globally, as well as overseeing all aspects of the company's Quality Management System. Lead all regulatory activities across multiple programs and therapeutic areas, including oncology, respiratory, autoimmune disorders, ophthalmology, and endocrinology.

Provide a range of regulatory affairs, drug development, clinical, quality & compliance, and medical writing services. Focus on integration of development strategy with commercial needs, to enhance value at time of product launch, through nuanced target-product profiling and integrated development planning. Provide seminars/instructional programs on such topics as GCP; strategic communications in regulatory submissions; managing and responding to FDA 483s and Warning Letters; high-performance project management for biopharma project teams; and strategic product portfolio management.

Camargo Pharmaceutical Services increases speed-to-market for pharmaceutical clients in the U.S. and abroad. As their strategic outsourcing partner, Camargo provides efficient, cost-effective comprehensive drug product development, clinical program development and regulatory services for Phases I-IV. Team Camargo members have realized over 150 FDA approvals for ANDA's and NDAs, both 505(b)(1)s and 505(b)(2)s, in a wide range of therapeutic areas.As Vice President, Global Program Management, facilitated the use of comprehensive project management methodologies across Camargo’s constellation of client programs, with an emphasis on rapid, cost-effective, risk-balanced, and successful execution. Oversaw the Program Management Office, Clinical Affairs, and Medical Writing, selected Quality/Compliance activities, and led major, enterprise-wide change initiatives encompassing infrastructure, process maturation, and training. As member of the senior leadership team, shaped organizational development through focused contributions to legal, human resources, IT, and compliance activities.

• Led all regulatory affairs functions, including both strategic and operational facets of RA. Provided comprehensive regulatory analyses of strategic development options and Agency positions. Led all company-FDA meetings/negotiations and managed all interactions with the Agency. • Responsible for all regulated product submissions for 5 active INDs and 1 (approved) NDA; led multidisciplinary teams to generate, review, and publish submissions. • Direct “in-the-trenches” experience with multiple eCTD platforms and dozens of electronic submissions, including the lead product eCTD NDA, which was approved in first review cycle.• Led all clinical trial operations, from contract negotiation and protocol development to final study report, including work with CROs, domestic and international clinical sites, investigators and opinion leaders, and the integrated study team. High success rate in achieving timeline/budget/quality expectations for complex trials of all phases. • Responsible for pharmacovigilance/SAE management/regulatory reporting programs.• Managed nonclinical studies, from contract negotiation to execution, reporting, evaluation of regulatory impact, and submission to regulatory agencies.• Managed selected CMO activities related to ongoing manufacturing and stability programs, as well as scale-up and process validation.• Administered successful federal grants programs, including the preparation of grant applications and managing active grant program (multiple NIH and DoD SBIR/STTR grants). Managed the company’s SRAs/CRADAs with multiple academic institutions.• Led quality, compliance, and audit activities, including internal Quality Systems, as well as CRO qualification, CMO and API supplier audits, investigations/CAPA, and risk management.• Managed significant number of consultants, thought leaders, and external contractors, including contract negotiation, performance/value, and deliverable reviews.

Director, Industry Programs • Responsible for a range of programs designed to increase Houston's momentum in life science technology commercialization and facilitate the maturation of the region as a life science economic cluster.• Developed and managed the BioHouston Partnering/Strategic Alliance program, an alliance “matchmaking” program with large pharmaceutical and biotech companies; managed similar program with non-regional venture capitalists.• Chaired/facilitated BioHouston programs related to clinical/regulatory affairs, technology transfer, and human resources; served in multiple ad hoc advisory roles supporting life science companies, academic programs, and service providers in the Houston region. • Served on or contributed materially to regional and state initiatives fostering economic and life science cluster development, including the Governor’s Cluster Initiative (Biotechnology), the Texas Emerging Technology Fund, and the Houston Mayor’s Economic Development Task Force.• Spoke frequently on topics including BioHouston, the economic potential of life science technology commercialization, the biotech industry, regulatory matters, and others (see partial listing below). • Addressed scores of other BioHouston operational and strategic needs, including business planning, fundraising, internships, public policy advocacy, media interaction, key writing projects, and outreach.Manager, BioHouston Resource Center (simultaneous with role as Director, Industry Programs)• Managed all aspects of day-to-day operations of a wet-laboratory incubator facility for early-stage biotechnology companies, including identification of and negotiation with potential occupant companies, forecasting and budgeting, and contract management. • Completed the transition-to-operations of this facility, after managing the acquisition of the facility.

• Led a wide range of clinical and regulatory projects, including the management of major international clinical operations initiatives and the planning and production of major and minor regulatory submissions.• Facilitated the maturation of the project management systems employed by the company, and provided project management leadership to a range of product-development projects.

• Successfully managed the merger integration of Aronex Pharmaceuticals and Agenus (then Antigenics), following Aronex’s acquisition, completing the integration ahead of schedule.• Following the merger, shaped strategy by providing quantitative and qualitative business-case and product-portfolio analyses in support of business development/licensing, investment decisions, and program management, using powerful financial modeling and market- and risk-assessment tools.• Analyzed markets and competitors for multiple oncology and infectious disease indications, and completed comprehensive analyses of several of the company’s products within the respective markets/competitive environments.

Associate Director, Program Management• Completed valuations of the company’s products, providing key information supporting merger and acquisition discussions following the restructuring of the company.• Implemented a Program Management Office, in continuation and extension of the introduction of project management systems to Aronex (as discussed under Project Manager).• Facilitated the maturation of the program management systems at Aronex, including the establishment of an infrastructure and methodology to allow the systematic and comprehensive planning, execution, control, documentation, and reporting of the company’s projects.• Managed the company’s drug-development program, including the entire range of pharmaceutical, preclinical, clinical development, NDA submission, and pre-launch activities.• Developed a Target Product Profiling and Integrated Development Planning process, linking drug-development activities to regulatory requirements and the needs of the marketplace.• Established and chartered product-associated project teams, and developed formal contract management systems and standards.Project Manager• As Project Manager for a liposomal systemic antifungal agent, coordinated all aspects of the drug-development program, including clinical, bioanalytical, and pharmacokinetic studies, and the preparation of an NDA dossier.• Managed the relationship with Aronex’s corporate partner, Abbott Laboratories, relating to late clinical-development activities and planned submission of the Nyotran NDA.• Introduced Project Management as a discipline to Aronex, developing requisite infrastructure, and implementing processes and policies to speed product development, reduce cost, and enhance the quality of outputs.Medical Writer• Wrote and edited a wide range of regulatory and clinical documents associated with multiple oncology and infectious disease indications, and managed the ongoing writing activities of the company.

• Wrote and edited various documents for the Medical Writing Department, including journal articles, backgrounders, meeting summaries, and book chapters.