The Cepheid Chief Medical Officer is a critical role reporting directly into the President.  This high visibility position is pivotal to our success as an organization, as this person will be a conduit of information between key Cepheid stakeholders, external government and regulatory agencies, the medical profession, other healthcare providers, and scientific communities.  This individual will be responsible for providing input into the medical need and justification for new products, their proper intended uses and their impact on patient care, assisting with appropriate clinical trial design, and the development and management of advisory panels, while simultaneously providing technical expertise for product prioritization and development.  As a strategic thought leader, this individual will have the transformative opportunity to shape strategy by understanding deeply the scientific basis for our technologies and how they should be designed for maximum impact.  This person will have will have deep insight into current and future medical trends, and the ability to translate these insights into business requirements globally as they relate to our worldwide installed base.

The successful incumbent will drive market introduction/penetration of the company’s products by providing clinical information, regulatory input, projected impact, and other related information. The incumbent will partner with external scientific/clinical organizations/individuals to further product application, industry positioning, and market awareness. The incumbent will build and lead the Medical and Scientific Affairs organization, including the newly created Medical and Scientific Liaison team.  The incumbent is an internationally recognized expert in diagnostics and the impact of timely, accurate and medically actionable information on patient care.

Essential Responsibilities

Scientific & Medical Affairs:

• Works with R&D functions to identify and evaluate markets for new disease areas or product improvements; provides input on new technologies and intellectual property issues.
• In partnership with L1 team members, designs and drives execution of medical affairs-related strategic goals and objectives, in keeping with overall company strategy
• Facilitates adherence to US regulatory requirements and International Conference of Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human use (ICH), pharmacovigilance and Good Clinical Practice (GCP) guidelines through the development and maintenance of applicable Company Standard Operating Procedures.
• Maintains effective ongoing relationships with external experts/consultants to provide medical and scientific support to the Company’s prioritized business initiatives
• Reviews and approves medical and scientific input for promotional and commercial activities as requested.
• Organizes and builds the Medical and Scientific Liaison team at Cepheid to actively engage with clinicians and other providers for conveying medical and scientific information in an unbiased and highly credible manner
• Works closely with R&D counterparts to identify and evaluate new biomarkers for infectious diseases, opportunities for product improvements and disruptive new product concepts.
• Actively engages with outside collaborators to explore new clinical applications and intended uses for existing products
• Provides strategic direction, review, and direct approval of clinical studies related to product development and commercial/ marketing activities.
• Attends and participates in research, standards, and clinical societies and conferences, and provides Cepheid with relevant intelligence updates
• Communicates research, development and strategically important market information to executive management
• Creates/facilitates company medical and scientific advisory boards and reports back to senior management
• Chairs company workshops and participates as an invited speaker at National and International Meetings

Safety:

• Patient safety is a top priority at Cepheid
• Provides medical support for patient safety board and direct customer interactions as needed
• Provides clinical input to Risk Assessments, Failure Mode Effect Analysis (FMEA), and Health Severity assessments within the risk management process
• Leads medical risk assessments with Senior Management. Review and comment on medical risk assessments for complaints; sign-off on reportability of Medical Device Reports (MDR)
• Reviews, updates and creates risk assessment documents related to potential product-specific malfunctions
• Identifies and reports any quality or compliance concerns and take immediate corrective action
• Complies with and contribute to the Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations
• May be required to interface with regulatory bodies (in collaboration with Clinical Affairs) regarding product discussions and questions

Education or Experience

• Combined MD/PhD degrees with 15+ years of clinical and translational research experience, ideally in Laboratory Medicine with Clinical Microbiology experience or Internal Medicine with Infectious Disease experience
• Published track record of research in Molecular Diagnostics
• International recognition as an expert in Molecular Diagnostics
•  6+ years managing people

Knowledge and Skills

• Medical Doctor with PhD in Genetics, Biochemistry, or Molecular Biology
• Concentration in Laboratory Medicine, Internal Medicine or Pediatrics with strong focus on Infectious Disease/Virology.
• Experience/prior oversight for risk assessment, patient safety & quality assurance processes
• Strong ability to make balanced business decisions; strong communication skills to effectively connect with the scientific audience as well as the ability to explain complex medical issues simply to a lay person; excellent interpersonal, organizational, and influencing skills; ability to work in a matrix environment and a motivational approach to managing others
• As the face of Cepheid to the external Medical and Scientific communities, this position requires exceptional written and oral communication skills
• Excellent interpersonal skills and the ability work with a wide variety of people (physicians, laboratory staff, marketing representatives, etc.) that will enable and maintain effective relationships with key externa opinion leaders/consultants to provide scientific support to the company’s business initiatives
• Domestic and international travel required - up to 40%
• Knowledge of regulations and standards affecting IVDs and Biologics
• Industry, product and customer knowledge required.
• Demonstrated leadership capabilities to direct a Medical and Scientific Affairs team.
• Demonstrated expertise in interpretation, summarization and presentation of scientific data required
• Demonstrated expertise in scientific writing (e.g. published manuscripts in peer reviewed journals, investigator brochures, or clinical sections of PMA and 510K submissions) required

Preferred Qualifications

• Global diagnostics market experience, including in developed and underdeveloped regions
• Strong Infectious Disease background