Helen Hernandez
Senior Director Program Management @Kalvista Pharmaceuticals, Inc
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WORK HISTORY
Senior Director Program Management @Kalvista Pharmaceuticals, Inc
Maintain the overall drug development plan including program budget and forecast and track program progress • Manage the Operations Team, e.g. Team meetings/agendas/minutes including drive and track actions and deliverables. Coordinate other Operations Team communication, e.g. identify key issues/areas for alignment and facilitate communication• Negotiate contracts, budgets, schedules and track deliverables for outsourced activities with Contract Research Organizations (CMC, nonclinical, regulatory, and clinical) and consultants• Serve as Clinical Study Manager• Member of the review team for GLP, GCP, and contracting SOPs• Member of the Senior Management Team
EDUCATION
New York Institute of Technology
B.S, Life Science
St. John's University
M.S, Biology
SKILLS
ABOUT HELEN HERNANDEZ
BACKGROUND: Certified Project Management Professional (PMP) with extensive experience managing programs and projects in Drug Development. Areas of project management include: Nonclinical, CMC, Clinical Phase 1 through Phase 3, Regulatory IND submission and annual updates, and Alliance Management. Therapeutic areas include diabetes, ophthalmology, HAE, and cardiovascular.Specialties: budgeting, communication skills, concept development, contract management, customer relations, delivery, executive management, clinical project management, ophthalmic drug development, diabetes trials, nonclinical project management, clinical research, GMP, GCP, GLP, microsoft project, Smartsheet, negotiation, plan development, progress, project management, research, spanish, timeline development, Smartsheet
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