Senior Manager, Clinical Product Development

Company: Thermo Fisher - America
Location: San Francisco
Posted on: January 15, 2021

Job Description:

Senior Manager, Clinical Product DevelopmentA pivotal member of the Genetic Testing Solutions Group who will work as part of a dynamic team of R&D professionals to execute on strategic IVD development projects. A Molecular Biologist with Clinical Development and Design Transfer experience in CE/IVD 510K Products. They will lead a team defining, designing, and executing product development activities throughout all phases of the product development lifecycle process for research and clinical applications.Responsibilities: * Lead a team defining, designing, and executing product development activities throughout all phases of the product development lifecycle process for research and clinical applications, aligning development activities with regulatory strategy and meeting organizational objectives.* Work cross-functionally with R&D, Product Management, Quality, Regulatory, and Manufacturing leaders to ensure that technical milestones, design transfer, customer satisfaction, and organizational goals are achieved.* Influence the product design by contributing innovative ideas, assessing the suitability of product design and features to meet the needs of the customer, and ensuring the quality of the product through rigorous testing.* Develop and implement procedures and processes to meet requirements for IVD product development.* Exercise influence across functional teams and engage with internal and external stakeholders.* Manage and develop R&D personnel.Minimum Qualifications (must have) Qualified candidates must have:* A degree in the field of Molecular Biology, Bioengineering, or a related field with a minimum of 10 years relevant experience in clinical product development for research, pharma, medical device or other relevant industry and a minimum of 3 years as a people manager.* Demonstrated success leading small to medium sized development teams, with the ability to meet technical objectives and solve complex challenges for IVD product development.* Experience with qPCR techniques and nucleic acid extraction methods, as well as knowledge of instrumentation and genetic analysis applications.* Experience working within a regulated medical device industry with strong knowledge or experience in FDA submissions.* Strong interpersonal skills with a proven ability to collaborate with others in a multi-disciplinary team setting, influence decision making, and build group consensus.* Excellent collaboration, communication, and presentation skills.* Greets challenge and change as opportunity.* Inspires, motivates and collaborates with others.

Keywords: Thermo Fisher - America, San Francisco , Senior Manager, Clinical Product Development, Executive , San Francisco, California