Robert Geckeler

About Robert Geckeler

As an Innovative and Creative Business Leader in the Pharmaceuticals / MedTech / SaaS / Consulting industry, I have experience in organizations ranging from pre-revenue startups to ~$3B global pharmaceutical businesses with proven performance managing service contracts up to $46M and annual operating budgets up to $15M. Throughout my career, I have led over 20 clinical-stage programs and advanced 7 assets from candidate selection to the clinic. To lead this achievement, I remain a capable mentor with a track record of attracting, recruiting, and advising teams of up to 25, building the foundations necessary to accelerate performance, increase revenue, and bolster shareholder value.ACHIEVEMENT CATEGORIES REPRESENTED BELOW• Operational Optimization• Product Turnaround• Clinical Trials• Regulatory Strategy• Product Development & Redesign• Service Optimization• Fundraising Enablement• Budgeting• Vendor Selection & Negotiation• International Communications• Client Relations• Reporting & Analytics• Sales Forecasting• Presentation Development

Experience

1. Drug Development Consultant Principal Managing Director

   Kelena Management

   Jan 2014 — Present · Encinitas, CA, US

   CORPORATE PROFILE: An Independent consultancy specializing in strategic planning and operations management. RESPONSIBILITY PROFILE: In this role, I am responsible for client drug development engagements across multiple therapeutic areas and product types, including delivery systems, nanoparticles, biologics, peptides, gene therapy, and small molecules. Leading these efforts, I plan/execute global clinical programs from POC to late-stage development, lead clinical operations and program/portfolio management, and oversee CDMOs to drive API processes, formulation development, and GMP manufacturing. I routinely engage regulatory authorities and strategize compliance for global jurisdictions. ACHIEVED IN THIS ROLEREGULATORY STRATEGY / CLINICAL TRIALS• A Top 50 pharmaceutical company repurposed a clinical-stage asset, but the new target indication created significant uncertainty for Phase 2. Hired by the Head of Program Management to recoup program delays. Collaborated with vendors to accelerate operations, established expert advisory panels to refine COAs/study design, finalized study protocols, prepared for two FDA meetings to secure COA acceptance, and developed central review capabilities to confirm local endpoint assessments. These actions accelerated the project by six months, maintaining the asset’s portfolio position and initial revenue forecast. This approach became a Best Practice applied to other programs.SALES FORECASTING• A pharmaceutical startup required a target product profile to develop a defensible revenue forecast. I was recruited by the CEO to support product valuation. In under 120 days, I oversaw payer/clinician interviews, generated primary market data, recommended price discount and revenue growth assumptions, and iterated the forecast model. Final forecasts proved more favorable than initially projected and improved asset valuation for licensing discussions. The consulting engagement was expanded to include additional products

Education

• San Diego State University

  MBA, Management

• Washington University in St. Louis

  BA, Biology