Required Director, Global Clinical Application, ITero.
Leverage clinical and product expertise to aid new concept and product development, define preferred embodiments of products, features, and algorithms, and evaluate compatibility of system components in clinical workflow scenarios.
Investigate and define clinical requirements for new devices and system features, drive integration of features into the existing clinical workflows, and facilitate the transition of these features into products through clinical review and evaluation.
Lead/own pre-defined clinical tasks such as definition, development, or validation of a system or sub-system, and drive them to on-time, high quality completion.
Interact with project teams and functional groups to define, design, execute and analyze feasibility studies, preclinical studies, product evaluations, data development and claims studies, technology assessments, concept studies, or benchmarking studies for Product teams. Act as the subject matter expert when making study decisions and guide the team in the right direction
Support the Product teams to define the clinical applications strategy for the business.
Translate research and studies discoveries into usable and marketable clinical workflows and indications.
Develop expertise in the scientific, technical, medical, and clinical aspects of iTero technologies/products.
Provide clinical input to the risk management process, including risk brainstorming.
Responsible to support the definition and execution of the business publication strategy, working with internal experts as well as key opinion leaders in the field.
Develop clinical validation plans and guide the execution of the clinical validation activities.
Support 510K, CE, and other regulatory submissions through publication search and summary, clinical claims, definition and proof, clinical study execution.
User guides and operator guides content creation.
Support, Biz support investigations and customer escalations.
Work with customer during the LMR (limited market release) phase to collect clinically relevant insight that could help create better evidence generation and improvement opportunities.
Functional leadership of the team, including recruitment, team/talent development, skill set improvement, and mentoring.
Resource assignment and prioritization including headcount allocations, Optimizing team's participation in all phases of product development.
Requirements:
Masters in Life Sciences, Chemistry, Physics, Biomedical Engineering or related field, PhD preferred
7 years relevant work experience
Direct reports leadership experience
Proven mentoring and coaching abilities; demonstrated ability to motivate & inspire others
Good Leadership and interpersonal Skills.
Proven ability to work cross-functionally
Excellent communication, influencing skills and ability to gain buy-in for initiatives
Demonstrated ability to deliver results while working on multiple projects simultaneously, balancing resources, timing and quality of outcomes
Demonstrated problem-solving
Experience in matrix organization environment
Strong written and oral communication skills
Self-driven, engaging, multi-tasking and results delivering
Experience working with customers.