Results oriented ADME expert with 24 years of pharmaceutical experience in small molecules and biotherapeutics pharmacokinetics, toxicokinetics, drug-drug interactions, pharmacodynamics, and drug metabolism research from early lead-development drug discovery, First in Human, Clinical Development, through Post-Registration in the US, EU and Rest of World. Specializing in helping teams reach discovery and development milestones. Proven track record of integrating data and information across disciplines (PK/PD, ADME, DDI, TK, Clinical Pharmacology) to accelerate and streamline project study plans. My passion for meeting unmet medical needs for patients including new formulations, and affordable medicines drives my success. I have experience with 30+ IND submissions and 10+ NDA submissions. Additional skills: IV, PO, SC, topical, ophthalmic, pediatric experience (PIP, PSP); drug substance comparability experience; IgG2, Fc Fusions, Enzyme replacement therapeutics and other modalities; technical depth and breadth; strong analytical skills; biosimilars; customer focused; strong interpersonal skills; deadline sensitive; cross functional coordination; detail oriented; resourceful.
Accomplished senior executive with over 30+ years of experience in pharmabiotech and medical device development. Entrepreneurial and technical operations background, excellent leadership and organizational skills. In depth experience in establishing and expanding operations to support, development of differentiated products and their global approvals, off-shore site set-up and management, development and management of revenue-generating collaborations and venture capital.
Versatile critical thinker with outstanding success in portfolio and project management. Drive research and development (R&D) business strategy through improving approach and methods for identifying, prioritizing, planning and executing development projects and key initiatives. Enthusiastically take on new challenges for continuous improvements. Build and empower high-performing teams to deliver organizational goals and objectives. Areas of expertise include: portfolio management, strategic planning, project management, operational planning & budgeting, governance decision making, lifecycle management, functional line management, process design and improvement.
Project leader specialized in managing local, global, and virtual teams to collaborate on complex scientific projects. Expertise includes management of cross-functional teams of department leaders, management of virtual teams with external consultants/vendors, and global drug development. Extensive experience in delivering operational goals and innovative/unprecedented projects. PMP certified project manager with project management and software training (MS Project). Expert in timeline management, team-building, and decision-making.