Cary, NC 737-***-**** firstname.lastname@example.org
Accomplished product and program management professional with strong leadership and communication skills.
PMP Certified project manager with 10+ years cross-functional, core-team leadership experience
Successful track record of developing, achieving clearance and launching multiple diagnostic products and medical devices under FDA and EU regulations within projected timelines and budgets
oExperienced operating under QMS processes including ISO 9001 and ISO 13485
Well-honed abilities to identify and mitigate risk, and manage costs, resources and schedules
Strong customer-focus that insures alignment between customer needs, program objectives and business strategy
Work Experience / Accomplishments – program management and Biotechnology
CEO, Lumedica Vision, Durham, NC 8/18 – 8/19
Chief Executive Officer of a medical device start-up base on technology from Duke University. Responsible for commercialization, investor relations, and financial planning.
Raised $500K in financial commitments from angel investors
Created and executed co-development agreement with strategic partner
COO, Clearbridge Biophotonics, San Diego, CA 6/13 – 1/18
Chief Operating Officer of a medical device start-up based on technology from CalTech. Responsible for commercialization, investor relations, financial planning, and instrument development.
Raised $5M of angel funding across 3 investment rounds
General Manager, Arista Molecular, Beckman Coulter, San Diego, CA 6/10 – 6/13
Head of high-complexity CLIA laboratory offering general oncology services and proprietary molecular
assays. Chair of PMO oversight committee.
Created and implemented comprehensive, phase-gate development process
Directed the design and implementation of the clinical trial to prove the clinical utility of the assay.
Launched and achieved business plan objectives for, ProsVue, a novel prostate cancer recurrence assay
Launched 20 complementary assays across a wide range of technology platforms.
Vice President, Marketing, Beckman Coulter, Brea, CA 1/08 – 6/10
Head of marketing for a business line with $120M in global revenues. Project manager and co-chair of the PMO oversight committee.
Conceptualized, led development and launched a family of urinalysis systems (IriCell Plus®) that drove global, business revenue growth to 2X the market average
Conceptualized and lead initial development of a paradigm-shifting hematology diagnostic system (3GEMS™) that triggered Beckman Coulter to acquire Iris International.
Sr Director, Strategic Planning, Siemens Medical Solutions, Tarrytown, NY 7/04 – 1/08
Head of global strategic planning functions. Responsible for the annual strategic planning process and played a leading role in allocating the $275M R&D budget across the full breadth of product-lines and individual projects. Awarded the prestigious Presidents Leadership Award.
Vice President, Marketing, DadeBehring, Sacramento, CA 7/02 – 7/04
Head of marketing for a business line with $130M in global revenues. Served as the chair of the PMO oversight committee.
Designed and implemented project initiation and concept phase components of the PDP, which introduced the concept of customer-centric product development.
Director, Product Development, DadeBehring, Sacramento, CA 1/99 – 7/02
Project manager and core team leader for a paradigm-shifting random-access microbiology analyzer.
Completed concept and feasibility phases on time and at budget targets with a total team of 70 individuals spanning 12 different business functions.
Eli Lilly & Company, Indianapolis, IN
Marketing Associate 3/93 – 5/95
Sales Representative 7/91 – 3/93
Education BS, Chemical Engineering, Virginia Tech - Blacksburg, VA