Senior Director, Clinical Research

The Clinical Research Sr. Director is responsible for leading the design, development and reporting of clinical trials in support of the research, development, registration and commercialization of products. This includes the review process for protocols, study reports, new and updated labels, and contributes to interactions with regulatory agencies. As required, supports the definition and implementation of the global clinical affairs strategy.

PRIMARY RESPONSIBILITIES:

• Responsible for managing and developing Clinical Research team and allocating team resources
• Provides leadership and mentorship to others especially those in the Clinical Affairs group.
• Collaborates with a multidisciplinary team in the development, creation and execution of study protocols
• Oversees development of strategies for clinical trials for US, EU, China and/or rest of world registration studies as determined by business priorities
• Establishes and approves scientific methods for design and implementation of clinical protocols and final reports
• Reviews and approves clinical study protocols and reports
• Review both clinical and analytical sections for regulatory submissions
• Manage and report on ongoing Clinical Affairs portfolios
• Develops and implements strategies for obtaining clinical evidence using the product evidence strategy plan process (PESP)
• Develops and maintains good collaborations with premier scientists in the field, in order to monitor priorities in the field, identify outstanding questions, and to review the literature to identify policy questions, or to predict market developments.
• Has and maintains scientific, technical and clinical expertise in infectious disease and oncology molecular diagnostics
• Responsible for clinical compliance function within the CACDMA organization
• Responsible for the technical writing and manuscript process within the Clinical Affairs function
• Reviews pertinent literature, prepares white papers/manuscripts, and provides education to Cepheid staff as needed.
• Monitors developments in the field of interest in order to be able to assess competitive activity, market development, and to identify opportunities to broaden service utilization.
• Ensures clinical data meets all necessary regulatory standards
• Interact with Regulatory Affairs and FDA or other regulatory and global (e.g. WHO) authorities regarding clinical research in support of product registration.
• Interacts internally and externally with executive-level management requiring negotiation of extremely difficult matters to influence policymaking bodies both internally and externally.

– Collaborate cross-functionally with Government Affairs, Medical and Scientific Affairs on pre- and post- market product studies

• Ensure that these 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.

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES (MINIMAL COMPETENCIES)

• Masters or PhD or equivalent experience
• 10+ years of relevant experience
• Have a proven track record in obtaining FDA clearance/approval of In Vitro Diagnostic (IVD) products, preferably in molecular diagnostics or immunodiagnostics, either in cancer or infectious disease diagnostics.
• Must have demonstrated accomplishment in obtaining diagnostic product clearances/approvals through U.S. FDA.
• Strong interpersonal, communication, presentation, and negotiation skills across all levels of the organization
• Performance oriented with ability to work along agreed timelines and a focus on strategy and execution
• Outstanding communicator. Excellent problem-solving, conflict-resolution and decision-making skills
• Fluent in English (verbal and written communication)

PREFERRED QUALIFICATIONS:

• 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.