Clinical Science Leader

The Director of Clinical Science, Infectious Diseases, provides clinical guidance for the development of new laboratory systems and diagnostic tests at Roche Molecular Diagnostics. The director identifies unmet needs for new products, defines their clinical requirements and leads the clinical development and validation strategy to register these products as In Vitro Diagnostics with the FDA and other regulatory agencies.

The incumbent will serve as a Medical and Scientific Affairs lead on the Systems Life Cycle Team and as Clinical Science Lead on several individual Project Teams developing virology assays.

The Director will work cross-functionally within Roche Molecular Diagnostics, collaborating most closely with Medical Affairs, Clinical Operations, and Biometrics, as well as Research, Development, Regulatory, Quality, Marketing and Business Development. The Director may work on collaborations with other Life Cycle Teams and other units of Roche Diagnostics and Pharma. This position is also the medical and scientific liaison between internal teams and external groups such as CROs, regulatory authorities, professional and public health organizations, key opinion leaders, and advisory boards.

This position will be based out of Pleasanton, California, reporting to the Head of Clinical Science, Medical and Scientific Affairs. The position provides senior clinical leadership internationally and across functions within RMD. There will not be positions reporting administratively into this role, but the incumbent is expected to foster individual development throughout the organization.

Specific Responsibilities:

• Serves as a medical leader and expert at RMD, keeping the company abreast of advances in clinical medicine, health systems and public health which relate to infectious diseases.
• Identifies areas of unmet medical need for diagnostics.
• Defines potential clinical utility claims for products. Provides medical/scientific input into and assists with the preparation of PMA and 510(k) regulatory submissions. Provides responses to regulatory agency questions.
• Assists Research and Development Groups with assay design and the design of performance verification and troubleshooting experiments. Reviews the data from these experiments from a clinical perspective.
• Develops product specifications to ensure that products will be safe, effective and clinically useful.
• Works with Clinical Operations and Biometrics to design, implement, interpret, report and publish clinical research studies to support product registrations. Identifies suitable academic partners, external laboratories and clinical sites to participate in clinical studies.
• Presents research findings in meeting abstracts and publications.
• Reviews product complaints to evaluate their potential clinical impact.
• Consults with key medical opinion leaders and provides guidance on the planning and implementation of adviser meetings

Position Requirements:

• MD, and/or PhD in microbiology, virology, or immunology
• 1+ years of clinical research experience with a proven ability to design clinical trials, and critically evaluate study results. More experience is preferred.
• Thorough knowledge of clinical trial design and statistical methods for clinical research
• Demonstrated ability to design studies, and write and review study reports and publications
• Understanding of molecular, microbiology and virology laboratory techniques
• Excellent organizational, communication, and project management skills
• Experience in interfacing with key opinion leaders including physicians and clinical laboratorians
• Must be able to travel domestically and internationally 10-20%

Preferred:

• 3+ years clinical experience in infectious diseases clinical care or in medical microbiology/virology. Board certification is a plus.
• Laboratory work experience, particularly in a clinical molecular laboratory.
• Master’s in public health with experience in local, national, and/or international public health program design, research, and implementation with experience in epidemiology and biostatistics
• Experience within the diagnostics, medical device or pharmaceutical industry, with a track record of FDA clearance or approval based on clinical trials  
• Thorough understanding of product development process for medical products
• Understanding of the regulatory requirements under which diagnostic and/or pharmaceutical products are developed, commercialized, and supported after sale
• Ability to build and foster global relationships