Darshan S. Email & Phone Number

19803, Wilmington, Delaware, United States

R&D Practices & Operations Excellence

Wilmington, Delaware, United States

Engaged in development of innovative medicines for patients with unmet needs

Wilmington, Delaware

Global Program Leadership for early stage assets in development (Inflammation & Auto-immunity)Led Cross-functional Launch Planning and Excellence for late stage assets in Oncology, Hematology, Dermatology (atopic dermatitis, vitiligo)

Greater Washington Dc Area

Deliver cross-functional global development for late stage products [various therapeutic areas]Global Product Team; Cross-functional sub-teams; Pediatric Development Plan; Life Cycle Management; Project Plan and Costs; Risk Register; Governance and Investment Relations materials

Core Team Member, TransCelerate Shared Investigator Platform; lead internal member company review of outputs. TransCelerate Biopharma is a consortium of 20 major pharmas and biotechsDrive education and adoption of innovative solutions in clinical site identification, feasibility, and selection; clinical study start-up and tracking; application of mobile/digital technology in clinical trialsAdvisory Board Member, Disruptive Innovations 2014 DPharm, Boston, September 2014Advisory Board Member, Advances in Clinical Technology, London, Septemeber 2014

Identify opportunities for acceleration of drug development projects, remove “white space” through use of lean sigma principles, develop options for governance approvalDrug Project Operating Model for Phase 2/3, Submission, Launch, and Product Maintenance, Continuous Improvement, Leading and Implementing training in Global Medicines Development organizationCo-founder of Project Management Community of Practice to foster continuous improvement through sharing of best practices and organizational learning

Global Product Team Project Management of various products in development: Development Strategy, Project Budgets & Development Time lines across all regions, Leading FDA Advisory Committee preparation, Pediatric development, Life Cycle Management, Alliance management.

Led Competitive Intelligence with actionable intelligence for top brands: Zyprexa ($5 billion), Evista ($1.3 billion), Diabetes franchise ($2 billion), and top priority development productsCo-authored Marketing Archetypes, a comprehensive study of major marketed products (development path, submission strategy, launch strategy, S&M spend, Pricing, DTC strategy, KOL and Advocacy Group strategy)

Cross-functional CMC team leader for 5 NMEs from lead optimization through Phase 2

Led implementation of managed care for 13,000 US-based employees including identification of health care providers, and key performance metrics development for annual performance

Led a $162 million Engineering (capital expansion) project including first ever Modular Construction project in company's history with responsibilities for design, implementation, validation, and start-up.Process engineering and Line management responsibilities for insulin manufacturing

Process, Project Engineering, and Supervisory responsibilities

Ms, Chemical Engineering

Bs, Chemical Engineering

Activities and Societies: First Class with Distinction