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Highlights:
- Over 20 years clinical research experience including Phase I-IV biopharmaceuticals studies including
FIH, EFS, Pivotal, PAS/PMS/PMCF Class III medical device studies - Project Management Professional Certified
- Graduate level faculty instructor of Project Management and Clinical Operations
- Device research supporting heart valve disease, congenital cardiac defects, peripheral vascular
disease, aortic disease, cerebral arterial disease, venous disease - Partnered with AdvaMed, NESTcc, & VQI to leverage real-world evidence (RWE) in support of
expanded indications and post-market regulatory needs. - BS Biology, BS Organizational Behavior; Personnel Management
- MBA
Take us through your work history by briefly describing the wins you’ve experienced and why you changed jobs/responsibilities:
His career began after he left medical school. He realized it was not his chosen destination but realized he preferred research, something he had done during the summer as an undergrad.
He excelled at a fast pace world of Phase 1 pharmaceutical research and was promoted to the Team Leader of the unit within 6 months. Successful study execution for companies like Roche, Bayer, Lilly, and Novartis drew repeat business and revenue growth sufficient to attract Covance to acquire their independent unit. His move to Eli Lilly was a natural one for career growth. He held roles in project management and study monitoring.
During his tenure, he saved $250,000 across three trials by designing Investigator training via CD‐ROM as a tool to increase training consistency and provide a tool for re‐training during the trial. He also developed a secure, online document repository for archiving study reports, tools, and resources. The entire Operations group used this database.
In addition, he trained at least 150 individuals on the process for utilizing the repository. Lastly, he developed processes for a newly created Assistant position, provided training to Operations staff, and served as a Technical Coach to the function. He received an award for his leadership on this project.
At Amgen, he worked remotely managing clinical trial sites for oncology and osteoporosis biological candidates. He moved from Amgen to a small biotech in Houston called Tanox. He began building out a team to conduct HIV and Oncology trials; however, roughly 5 months after starting the company was sold to Genentech and he ultimately moved on to the device space at WL Gore & Associates.
He’s spent about 12 years with Gore in capacities of Study Manager, Global Project Manager, Strategist, and presently as leader for Cardiac Clinical Affairs. He is proud of the followership he’s developed there. Some key achievements include successful FDA and PMDA audits of several studies he executed as well as several for the teams he leads. He served as the PM for the largest and longest device study in the industry – 5000 patients, 10-year follow-up global postmarket registry. This entailed working with 7 global KOLs and regional study managers to achieve enrollment objectives and presentation/publication of results.
He led their participation in the NESTcc/FDA pilot program for real world data collection. He spoke on a panel representing industry experience with this pilot along with the FDA CDER Director and NESTcc Executive Director at the
MedTech conference in 2018. In addition to leading the Cardiac Clinical Affairs organization, he has served as functional leader for the Clinical Strategy team within Clinical Affairs. Under his leadership, this group has evolved from 3 to 7 people as the value has been demonstrated and has established standard practices to assure consistent deliverables.
He is accountable to an annual budget of $10MM (and growing) and for study team conduct (quality, metrics, endpoints, etc.). There are roughly 45 FTEs presently. He is directly leading 2 Program Managers, 2 Strategists, and 2
Science Liaisons (data dissemination).
In other words, what would you consider your greatest accomplishment(s)?
He is extremely proud of his recent work building out the Cardiac Clinical organization. Growing the team to support tremendous growth over the next 5 years – hiring Study Managers and Strategists to support this team. Identifying and selecting vendors to support heart valve studies (monitoring, DSMB/CEC, imaging core labs, consultants, executive committees). He’s focused on establishing “master service agreements” with vendors enabling us to initiate studies for products emerging from pre-clinical work without delay and expediting time to market.
He is extremely proud of his recent work building out the Cardiac Clinical organization. Growing the team to support tremendous growth over the next 5 years – hiring Study Managers and Strategists to support this team. Identifying and selecting vendors to support heart valve studies (monitoring, DSMB/CEC, imaging core labs, consultants, executive committees). He’s focused on establishing “master service agreements” with vendors enabling us to initiate studies for products emerging from pre-clinical work without delay and expediting time to market.
What was your greatest learning in your career?
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Trusting in others and using an adaptive approach to leading others. |
Why should prospective clients be interested in your candidacy?
He has a breadth and depth of experience that enables him to deliver on projects individually as well as developing a team to achieve organizational objectives. Injecting levity into work is a common practice – He genuinely believes this can be fun and he wants teams to feel comfortable engaging with him.
He strives for a collaborative approach to decision making but is willing to be a dissenting voice and make unpopular decisions when in the best interest of long-term success (e.g., site selection, quality assurance, KOL recommendations). Healthy debate is great and a good way to understand the ideas of others. He has a scientific background (including time in medical school), business acumen, and project management expertise. He has managed/led diverse functions to achieve organizational deliverables. Lastly, he enjoys presenting and representing his teams’ work to leadership.
What activities, community involvement, etc., outside of your career have you, or are you now, participating in?
On a personal note and with activities involving community involvement, he’s been a youth soccer coach over the past 10+ years; served as trail-building coordinator for Gore Associates in partnership with the National Forest Service; Taught graduate level Clinical Research and Project Management courses at ASU in Tempe, AZ. He enjoys ultrarunning (50m, 100k, and 100-mile races) and completed the Grand Slam of Ultrarunning (4- 100 miler races in 10-week period). He has run across the Grand Canyon and back in about 12 hours.
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