Director - Business Development - BioPhase Solutions - Torrance

Job description
The position of Business Director will be responsible for leading the commercialization and overall business operations for new for an exciting new sample collection and preparation device for the both the Pharmaceutical Research and Clinical Chemistry/Diagnostic markets. This role will be tasked with the development and execution of a commercialization road map, including supply chain development, vendor identification/evaluation, engineering needs assessment, coordination of internal resources, and assisting in building the necessary infrastructure to support product introduction. Further the role of Business Director with oversee the development of the Sales and Marketing functions, including development of sales and marketing team, distribution, and business develop opportunities.
This individual will also interact closely with internal R&D and Marketing staff, as well as external customers and consultants to assist in defining markets/market opportunities, navigating regulatory pathways to introduction in these key markets, and the development and execution of marketing and related business strategies to bring these products to market. Development of project timelines and communication to key stakeholders and team members will be vital.

Job Duties and Responsibilities

Commercialization program planning and execution for laboratory/clinical consumable devices
Further Develop overall Business Plans for Sales, Marketing and Operations, including development of Sales and Marketing team
Overall responsibility for strategic planning for the product line, including market identification, market development, sales strategies, regulatory acceptance pathways, and product introduction plans
Work with R&D and Marketing to finalize product and engineering requirements, designs, specifications, and cost/budget projections.
Working with a contract manufacturing firm, development of supply chain for raw materials, components, and assembly of devices
Develop and execute, in coordination with internal and external resources, a plan for achieving medical device certification, including determining quality and manufacturing requirements
Coordinate cross-functional teams in R&D, Marketing and Sales, as well as external vendors and consultants to meet program goals.
Develop, control and communicate project milestones and timelines to key stake-holders for an on-time product introduction
Hiring, development, and discipline of staff as required.
Domestic and International Travel up to 25% as required during development or product introduction.

Skills and Experience

· Bachelors Degree in Biomedical Engineering, Life Sciences, or related field
· >5 years demonstrated executive management or business operations experience in life science, clinical diagnostic or medical device field.
· Strong supply chain management experience, including supply, licensing, and quality agreement development and negotiation
· Demonstrated direct experience and understanding of the 510K/CE approval process for Class II medical devices for clinical chemistry or equivalent.
· Sound understanding of Liquid Chromatography/Mass Spectroscopy (LC/MS) in pharmaceutical bioanalysis and/or the clinical laboratory
· Strong leader that is able to motivate, influence, and direct others in a cross-functional, cross-department environment
· Energetic self starter with initiative to drive projects, deliver results on time, and overcome hurdles
· Demonstrated experience in strategic planning for new product introduction

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