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Skills & Expertise

  • Record of a focus on results with demonstrated drive to meet targets and act decisively to ensure completion of projects and growth of business.

  • Team builder.

  • Problem solver.

  • Experience directing a portfolio of clinical trial projects or programs through others.

  • Experience with direct-line management of others in a drug development environment.

  • Strategic/big-picture thinker.

  • Program management experience including directing activities in non-clinical, CMC, regulatory, first-in-human, pharmacology, biomarkers, proof-of-concept, and pivotal clinical trials.

  • Experience in multiple therapeutic areas.

  • Excellent organizational skills with the ability to manage multiple and varied tasks and prioritize workload.

  • Comfortable working with multiple stakeholders in a matrix and global environment.

  • Broad business expertise including budget management, strategic planning, and revenue forecasting.

  • Strong business acumen and skills in matters related to resource management and revenue enhancement.

  • Excellent presentation, persuasive verbal and written communication skills, with ability to influence others.

  • Solid knowledge of industry regulatory laws, ICH regulations, and GXP.

  • Experience preparing INDs and NDAs, including FDA meeting packages and FDA meetings

  • Extensive pharmaceutical experience negotiating with and directing vendors and CROs.

  • Flexibility with respect to work assignments, new learning and travel.

Nearly 30 years organizing, planning and developing global drug development teams. Moving molecules from discovery to approval.

+1 208-840-0119

Email: Steven@NortonClinicalDevelopment.com   

Preston, ID

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