Subject matter expert in molecular diagnostics with a solid comprehension of the key industry trends and competitive landscape. Possess knowledge and work experience in molecular diagnostics development, pilot and scale-up manufacturing, analytical verification and clinical validation..
Experience in applying design control and phase gate driven product development processes for the development of IVD assays, medical device systems and hardware platform products in accordance to ISO 13485
Experience in managing development projects in a IVD setting as well as multi-project experience is highly desiredGood understanding of applicable IVD medical device regulations, FDA design control process, and ISO 13485 standards preferred
Soft Skills:
Ability to network and build strategic partnerships.
Proficient in both people management & project management
Leadership experience and ability to coach and train junior members
Strong team player and communication
The candidate is required to:
• Resource management and division workplanning, including strategic focus, pipeline and portfolio development and management, division budgeting, resource allocation, etc.
• Technology evaluation and scouting for project pipelines development.
• Communicate regularly and effectively with researchers, clinicians and industry to conceptualize and design novel, clinically relevant and commercially viable medical device products.
• Work with both internal and external stakeholders to define project plans and budgets, develop and maintain project timelines, establish and monitor project risks and risk register and lead the project teams to achieve project deliverables and objectives in accordance to ISO 13485.
• Line manage of a team of 10 or more project managers and development scientists.
• Evaluate, initiate and execute medical device product development projects of various developmental stages towards commercialization.
Requirements:
Technical Skills:
• Subject matter expert in molecular diagnostics with a solid comprehension of the key industry trends and competitive landscape.
• Possess knowledge and work experience in molecular diagnostics development, pilot and scale-up manufacturing, analytical verification and clinical validation.
• Experience in applying design control and phase gate driven product development processes for the development of IVD assays, medical device systems and hardware platform products in accordance to ISO 13485.
• Experience in managing development projects in a IVD setting as well as multi-project experience is highly desired.
• Good understanding of applicable IVD medical device regulations, FDA design control process, and ISO 13485 standards preferred.
Soft Skills:
• Ability to network and build strategic partnerships.
• Proficient in both people management & project management.
• Leadership experience and ability to coach and train junior members.
• Strong team player and communication.
Qualifications:
• PhD in Life Sciences, Biotechnology or related field.
• 10+ years of similar experience.
