Monument, Colorado, United States
Accomplished product development Program Manager and Operations Leader (ISO 9001/13485). Highly skilled at strategic planning, program management, change and risk management and operations continuous improvement. Adept at focusing cross-functional product development teams in a fast-paced, resource constrained startup environment. Experience covering requirements generation through product launch and support. Proficient at prioritizing and implementing complex project plans in a coordinated manner to advance organizational effectiveness and improve commercial viability. Outcomes-oriented, analytical and quickly develops new subject matter proficiency. Collaborative change manager skilled at team integration, coaching and negotiation. Dependable self-starter holding himself and his teams to the highest standards. Ready and willing to roll up my sleeves and do whatever it takes to enable successful teams and products. Strong sense of ownership.
Responsible for providing high level Program and Operations visibility and prioritization guidance to Executive team. Accountable for establishing cross-functional operational rhythm, developing end to end workflow solutions and leading implementation projects.
Led matrixed pre/post clinical projects, a research team (15 FTE) and managed laboratory operations (70 FTE). Accountable for achieving pre-clinical project team milestones, Lorcaserin/BELVIQ(R) NDA submission and FDA approval, timely APD334 and APD371 IND submissions and development of research/operations strategy and best practices.
Description blended above with Directorship description.
Managed lead-identification/optimization projects (15 FTE), discovery laboratory operations (70 FTE) and established tissue culture core facility (3 FTE). Accountable for achieving lead-identification/optimization and exploratory development goals (directly, through CRO’s and by collaborating on preclinical project teams) while improving the overall quality and cost-effectiveness of research across discovery groups.