Results-oriented, I am consistently recognized for my ability to envision possibilities, and my passion as a connector. I will add value to your company's bottom-line through my extensive Product Development & Launch, Clinical Research, Risk Assessment & Mitigation, and Alliance Management experience, described below:
Management Executive and proven innovator shaping consumers' interactions with products through expert leadership of development programs. Leverages background in regulated environments to establish highly efficient systems, processes, and tools; led multiple regulatory submissions and launches in Asia, Europe, and North America.
�Created global product development vision, strategy, and operational plans to position Fortune 50 company as leader in women's health via unique post-menopausal treatment. Captured $200M+ in Europe and prepared FDA submission.
�Led team that identified hair-loss prevention benefits of Head & Shoulders and formulated credentialing and outreach strategy to leverage discovery to drive incremental revenues beyond $1B.
�Incorporated "voice of the consumer" into features profile for post-surgical pain product; completed cross-cultural research in pain response in Asia, Europe, and North America within 2 months.
Program Leader architecting processes to expedite product development cycles and increase quality.
Proved instrumental to creation of infrastructure for company's first new drug application (NDA); produced interactive online roadmap and training courses for 150+ team members/partners aligned with FDA regulations.
Concluded quality-system procedures assessments for pre-approval inspection preparations within 6 months vs. 12-month schedule; coordinated 100 personnel in SOP definition, gap analysis, process revisions, and training.
Finalized development and chemistry manufacturing controls (CMCs) for first-generation NDA 3 months ahead of schedule and propelled second generation to clinical research stage 1 year ahead of schedule.
Collaborative Leader forging productive external partnerships to expand capabilities and speed time-to-market.
Overcame product-development roadblock by bringing together patent owner, technology provider, and lead marketing company; achieved buy-in from all parties and set contract milestones and metrics.
Saved 10%+ and completed product engineering 3 months faster than forecast by pairing complementary design and engineering firms to create parallel process for consumer research and design.
Accelerated projects up to 50% through outsourcing of non-core functions, thereby supplying turnkey solution to hasten response to competitive threats.