World leader in the field of in vitro diagnostics for over 55 years, bioMérieux conceives, develops, produces and markets diagnostics solutions (systems, reagents, software and services) intended for clinical and industrial applications, which determine the origin of a disease or a contamination to improve thehealth of patients and insure consumer safety.
bioMérieux is present in 43 countries and services more than 160 countries with the support of a large network of distributors. Its corporate headquarters are located in Marcy l'Etoile, near Lyon, in France.
Joining bioMérieux, is choosing to join an innovative company with a long term vision, committed tothe service of public health and carried out with a humanistic corporate culture.
We look for candidates whose motivation is to invest in themselves, in the projects of the future, andto participate in a collective adventure led by a pioneering spirit.
We have the commitment to offer our collaborators a working environment which encourages team spirit, with priority given to training and development with international career opportunities.
Our Group offers numerous possibilities: so come and join the 11,200 bioMérieux employees who have already identified with these values!
Astute Medical, Inc. is an in-vitro diagnostics company dedicated to improving the diagnosis of high-risk medical conditions through the identification and validation of protein biomarkers that can serve asthe basis for novel in-vitro diagnostic tests. To support the commercialization of its novel biomarker products, Astute Medical is seeking an energetic, experienced, highly motivated and collaborative individual for the position of Product Strategy Director.
This position plays a key role in bringing new products, product systems, and services to physicians which will help inform treatment decisions for patients at risk for acute kidney injury. The Product Strategy Director will work within a cross-functional Core Team under design controls from product feasibility through product commercialization. S/he will perform
activities under the Quality Management System and following Astute's Product Development Process.The ideal candidate will be a strong contributor and influencer with a proven track record in successful IVD product development. The position will report to the Chief Executive Officer/Chief Scientific Officer.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Key member of the Design and Commercialization Core Team for Astute's kidney injury products working under design controls from feasibility through commercialization.
- Perform business analysis review summaries, including business risks, ROI and resource/timeestimates. Report contract / quality agreement status for partners / vendors involved in product design, manufacture, and distribution.
- Understand and communicate external trends affecting the program (especially scientific, technological, and medical) to influence plans for growth, product iteration, and commercial viability.
- Elicit customer needs and draft summary documentation, including links to supporting marketing research, competitor analysis, surveys or other data, and input from the Core Team and key external stakeholders.
- Translate customer requirements into product requirements and technical requirement specifications in collaboration with Product Development/Quality Assurance. Provide status updates through outputs, verification and aid in the documentation of traceability matrices.
- Build consensus across a range of stakeholders to define the product commercialization strategy and roadmap. Document this strategy and roadmap defining key deliverables, milestones, dependencies, risks and mitigations including: activities to support global product launch, plans for product support (field and internal), training of service and support personnel (e.g., customer complaint personnel, instrument field service, technical consultants) and training for customers. Provide on-going status reports on activities / deliverables related to commercialization strategy.
- Coordinate forecasts with input from impacted internal and functional areas such as Product Development, Materials Management, Clinical Affairs, Marketing etc., encompassing the needs forinternal testing, external studies, and launch.
- Write Post-Launch Product Marketing Summary with key stakeholders, including review of key post-launch marketing strategies, plans, evaluations and accomplishments, review of customer satisfaction, product acceptance, and challenges and successes in the field.
- Manage inputs and draft Post-Launch Product Distribution & Sales Summary, including summary ofproduct distribution& sales by region &/or country, profit margin, sales forecast, and review of product cost and sales prices.
- Ensure all design control activities are performed in adherence to applicable national/international regulations, guidelines, company policies, SOPs, and industry standards.
- Develop external relationships with key opinion leaders.
- Perform other responsibilities as assigned.
- Masters degree in Life Sciences, preferably Biology, Chemistry or Biochemistry, or equivalent experience. Advanced degree (Ph.D. or M.D.) in one of these disciplines preferred.
- 5+ years industry relevant experience in development of IVD products or equivalent experience in other IVD or medical device spaces, required.
- Proven ability to manage the interface between Product Development/Quality/Regulatory and Market Development requirements and activities.
- Demonstrated understanding of ISO 13485 and Code of Federal Regulations (CFR) 21§ 820.30 Design Controls and previous experience developing products (diagnostic tests, reagent kits or diagnostic systems) under design controls.
- Ability to research, obtain, coordinate, and integrate feedback and directions from diverse operational groups and organizations into a written product or presentation.
- Adept in prioritizing and managing multiple concurrent projects to drive to results with a highemphasis on quality.
- Ability to work independently, exercise sound judgment, manage diverse and conflicting priorities and projects in an effective manner, and meet deadlines.
- Strong communication skills (verbal & written) including ability to interact positively with all levelsof internal and external collaborators.
- Ability and willingness to travel ~25% (domestic and international) for meetings, trainings etc. andto accommodate meetings outside of traditional working hours.
- Ensure compliance with Company's Quality Management System.
- Proficient with Microsoft Office suite.
While performing the duties the employee is:
- Constantly required to reach computers and other office equipment.
- Constantly required to view objects at close and distant ranges.
- Frequently required to communicate with others.
- Frequently required to sit.
- Frequently required to stand.
- Frequently required to use fine manipulation and simple grasping in order to handle laboratory equipment and to utilize the computer and other standard office equipment such as telephone, fax machines, copiers, etc.
- Frequently required to lift and transport items weighing up to 25 lbs.
Note: For the purpose of this summary, occasionally is used to represent up to 1/3 of the time givento the work day, frequently represents 1/3 to 2/3 of the time and constantly represents 2/3 or moreof the time