Job Description
This individual will translate the company’s scientific strategy into functional plans, processes and practices to develop and deliver new or companion diagnostic products. She/he is responsible for managing cross-functional and multi-site resources to deliver projects on schedule and on budget according to regulatory requirements. The R&D team consists of 200 employees worldwide. This position will have 5 direct reports.
Responsibilities
Functional head for all division R&D activity, covering clinical development for the Diagnostics Division.
A member of the senior management team, he/she will lead and direct all product development activity in support of meeting the division’s goals and ensuring adherence to global regulatory requirements.
Ensures that all product development activities are resourced appropriately and that timelines and budgets are tracked according to the project plan.
Actively involved in leading the divisions overall scientific strategy.
Ensures benchmarking to industry best practices for development and transfer processes.
Act as the division's primary scientific representative at an international level through engagement with key opinion leaders in the division’s core markets, with other PKI research and development leaders, and with any external product development partners.
Identify and propose areas for reduced development timeframe with a constant focus on innovation.
PhD in Life Sciences or related field
10-15 years in IVD product development including at least 5 years at a senior level
Knowledge of manufacturing/operations and product support in the lab services strongly desired
Outstanding leadership, broad scientific knowledge
Knowledge of global medical device/IVD regulatory requirements, experience in cGMP, GMP environments
Effective team building and coaching experience
Financial planning, budgeting and critical thinking skills
Ability to problem-solve, recommend and deliver business strategies at an executive level
Extensive experience reducing product development time and budget
Design of innovative practices to improve product outcomes
Track record of innovation and achievement in technological advancement
Outstanding interpersonal, presentation and communication skills, both written and oral
Results driven individual with high level of enthusiasm and energy
Ability to travel globally
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This individual will translate the company’s scientific strategy into functional plans, processes and practices to develop and deliver new or companion diagnostic products. She/he is responsible for managing cross-functional and multi-site resources to deliver projects on schedule and on budget according to regulatory requirements. The R&D team consists of 200 employees worldwide. This position will have 5 direct reports.
Responsibilities
Functional head for all division R&D activity, covering clinical development for the Diagnostics Division.
A member of the senior management team, he/she will lead and direct all product development activity in support of meeting the division’s goals and ensuring adherence to global regulatory requirements.
Ensures that all product development activities are resourced appropriately and that timelines and budgets are tracked according to the project plan.
Actively involved in leading the divisions overall scientific strategy.
Ensures benchmarking to industry best practices for development and transfer processes.
Act as the division's primary scientific representative at an international level through engagement with key opinion leaders in the division’s core markets, with other PKI research and development leaders, and with any external product development partners.
Identify and propose areas for reduced development timeframe with a constant focus on innovation.
PhD in Life Sciences or related field
10-15 years in IVD product development including at least 5 years at a senior level
Knowledge of manufacturing/operations and product support in the lab services strongly desired
Outstanding leadership, broad scientific knowledge
Knowledge of global medical device/IVD regulatory requirements, experience in cGMP, GMP environments
Effective team building and coaching experience
Financial planning, budgeting and critical thinking skills
Ability to problem-solve, recommend and deliver business strategies at an executive level
Extensive experience reducing product development time and budget
Design of innovative practices to improve product outcomes
Track record of innovation and achievement in technological advancement
Outstanding interpersonal, presentation and communication skills, both written and oral
Results driven individual with high level of enthusiasm and energy
Ability to travel globally
More Jobs in 100k: Visit US
