Manager Clinical Research at Cepheid

ESSENTIAL JOB RESPONSIBILITIES:

• Develops and manages strategies for obtaining clinical evidence using the product evidence strategy plan process (PESP)
• Responsible for managing and developing clinical research scientists
• Oversees development of strategies for clinical trials for US, EU, China and/or rest of world registration studies as determined by business priorities
• Oversight for clinical strategy, protocol development and clinical study reports for China FDA registration studies.
• Leads cross-functional collaboration on development of clinical strategies, plans and protocols for product approvals and expanded indications consistent with the company’s needs and priorities
• Authors and reviews clinical study protocols and reports in compliance with relevant SOPs and guidelines
• Supports preclinical and clinical sections for new products for oncology and infectious disease platforms
• Has and maintains scientific, technical and clinical expertise in infectious disease and oncology molecular diagnostics
• Collaborate cross-functionally with Government Affairs, Medical and Scientific Affairs on pre- and post- market product studies
• Ensure that activities are conducted in compliance with current applicable regulations, laws and guidance including but not limited to US, EU and China regulations as well as with Cepheid’s policies and procedures.

TRAINING RESPONSIBILITIES: (REQUIRED)

• Complete all assigned and required training satisfactorily and on time
• For people managers, ensure your associates attend and complete all required trainings satisfactorily and on time.

Minimum Requirements
Education and Experience:

• Bachelor’s degree in field with 9+ years of related work experience OR
• Master’s degree in field with 7+ years of work experience
• Experience with in vitro diagnostic (IVD) products
• Strong scientific background with deep understanding of infectious disease and oncology molecular diagnostic areas

Knowledge and Skills:

• Has excellent understanding of In Vitro Diagnostic (IVD) regulations and has supported product approvals, preferably in molecular diagnostics or immunodiagnostics, either in cancer or infectious disease diagnostics.
• Strong interpersonal, communication and presentation skills
• Goal-oriented with ability to work to deliver on timelines without compromising on quality
• Strong communication, problem-solving, conflict-resolution and decision-making skills
• Fluent in English (verbal and written communication)
• Robust medical writing skills who fosters an environment of accuracy with keen sense of attention to detail.

PREFERRED REQUIREMENTS:

• A Masters or PhD in Clinical Sciences, Health/Life Sciences, Molecular Biology, Biochemistry and/or Human Physiology
• Strong scientific background with deep understanding of infectious disease and oncology molecular diagnostic areas

PHYSICAL DEMANDS

• Approximately 20% travel including international

The statements in this description represent typical elements, criteria and general work performed. They are not intended to be an exhaustive list of all responsibilities, duties, and skills for this job.