This position is responsible for working with physicians, laboratory directors and personnel, and scientific and academic researchers to address medical questions related to Cepheid infectious disease products and test results, provide medical/ clinical expertise to core team and product development, and to develop clinical studies and scientific strategies that build data supporting use of Xpert assays for pre- and post-launch market penetration.
ESSENTIAL JOB RESPONSIBILITIES:
- Analyze discrepant result reports and investigate causality
- Assess potential safety risks for diagnostic tests and contribute to risk management assessments
- Assess potential safety and adverse events related to Cepheid products
- Identify study sites for early adoption studies for products to be launched
- Liaise with and engage study sites, collaborate as needed on study protocols and monitor product evaluations to completion
- Assist with trials management with investigator-initiated studies, including securing research contracts, logistics of study start-up, and updates for ongoing studies
- Generate scientific awareness of Cepheid products pre- and post-launch
- Present at national and international meetings to increase portfolio visibility
- Coordinate meetings and visits with thought leaders for competitive intelligence
- Leverage thought leader relationships by aligning their expertise with Cepheid needs
- Facilitate collaborative relationships with thought leaders internally as advisors, consultant, investigators, expert guest speakers and business development partners.
- Regularly collect and interpret insights in the medical diagnostics environment and provide feedback regarding competitive intelligence
- Keep abreast of competitive position for Cepheid products
- Communicate effectively with the Scientific Advisory Board, Laboratory Focus Groups and Key Opinion Leaders (KOL's) to assist marketing in requirements are for product pipeline.
- Serves as key contact for input and interpretation of issues that impact product performance and reliability with ongoing studies.
Education or Experience (in years):
- Bachelor’s degree with 12+ years of related work experience OR
- Master’s degree in field with 8+ years of related work experience OR
- Doctoral degree in field with 5+ years of related work experience.
- PREFERRED: Medical Degree (MD, MBBS, or equivalent) and specialization in Infectious Diseases or HIV medicine (adult or pediatric) with 3+ years of related work experience after completing fellowship
- Doctoral degree in Medical Microbiology with 5+ years of clinical or industry work experience.
Knowledge and skills:
- Experience and knowledge of infectious disease diagnostic test interpretation and their applications to medical management of patients
- Knowledge of principles of real time PCR and its applications
- Ability to effectively present information and respond to questions from employees, managers, executive management, vendors and customers.
- Requires the ability to work as a member of a multifunctional team, strong interpersonal communication and organizational skills and planning ability.
- Skilled in effective presentations of medical data and materials
- Ability to read, analyze and, professional journals, technical procedures, or governmental regulations.
- Must be able to lift 25 lbs. Must be able to stand for several hours. Work may involve repetitive arm/wrist motions.
- Physical travel is required and will be up 30%
PREFERRED REQUIREMENTS (optional):
- 3+ years of successful experience in industry within a diagnostic arena.
- Experience in FDA regulated environment desirable.