Jeff Holsapple

About Jeff Holsapple

Program Management, Business Development, Operations, and Product Development leader who drives revenue and competitive market advantage by leveraging a valuable blend of technical, clinical, business expertise to achieve objectives. Comprehensive background in biotech, medical, and pharmaceutical industries, in startup and Fortune 500 environments. Establishes lucrative new revenue streams anchored by the design and development of key services, profitable product offerings, and lasting client relationships. Avid, agile learner who takes advantage of opportunities to develop new skills and become a more valuable, knowledgeable resource to the organization. Motivates and engages teams, leads by example, and communicates effectively at all organizational levels, across functional areas, and with customers. • Generated $1.5M over 3 years by creating a new revenue stream which led to preferred provider status; recognized by senior leadership and resulted in a Kansas Biosciences Authority (KBA) voucher award• Key role in growing startup from $7M to $22M annual revenue; provided support for 90% of total revenue• Added as much as $1M per year (20% of revenue) by negotiating new client services and offerings• Developed an interactive scheduling/tracking system database that drove process improvement, enhanced strategic planning, and provided key metrics; model was benchmarked and rolled out company wide• Increased productivity 50%, sped product time to market, and improved precision/accuracy of data collection and resource utilization by automating key processes• Revolutionized processes by implementing use of leading-edge technology; decreased sample preparation from 45+ minutes to 3 minutes with 10-fold better sensitivity with new instrumentation and 50% less material use• Drove 5% to 15% increase in incremental revenue in <2 years by establishing 2 new offerings

Experience

1. Clinical Study and Vendor Oversight Management Global Site & Study Operations Clinical Development

   Pfizer

   May 2018 — Present

   Lead study management execution of clinical studies from start-up to CSR completion and support inspection readiness for Study Management components with oversight of CROs and vendors. Collaborates across functions to build robust start-up, recruitment, retention and monitoring plans Leads early engagement and coordination of key partners through study start-up. Ensures timely delivery and quality of study management deliverables through the CRO Provides leadership, direction, and oversight to CROs and vendors Represents the CRO on matters of study management execution. Uses data to drive decision making, optimize oversight and enable Best in Class planning for study execution deliverables. Ensures transparency and proactive mitigation of risks Works with functional lines and CRO functions to resolve for triage site level issues

Education

• Baker University

  MBA, Business Administration

• Kansas State University

  Bachelor's Degree, Chemistry and Biological Sciences

Skills

• Collaborative Leadership
• Operations Management
• Glp
• Adme
• Vendor Management
• Regulatory Affairs
• Lifesciences
• New Business Development
• 21 Cfr Part 11
• Organizational Leadership
• P&L Responsibility
• Quality System
• Analytical Techniques
• Cross Functional Team Building
• Business Development
• Clinical Development
• Assay Development
• Biotechnology
• Bioanalytical Chemistry
• Mentoring
• Mass Spectrometry
• Biochemistry
• Coaching
• Hplc
• Emerging Technologies
• Method Development
• Technical Leadership
• In Vitro
• Drug Metabolism
• Manage Client Relationships
• Automation
• Pharmaceutical Industry
• Sop
• Fda
• Analytical Chemistry
• Chromatography
• Dmpk
• In Vivo
• Pharmacokinetics
• Employee Engagement