F. Hoffmann-La Roche Ltd
'Director of Clinical Science, Infectious Diseases','2520139352','!*!The Director of Clinical Science, Infectious Diseases, identifies unmet medical needs in infectious diseases, develops target product profiles for microbiology, virology and host response assays, using molecular technologies such as PCR and Smarticles. The Director will define the clinical requirements for these assays and lead the clinical development and validation strategy that will lead to In Vitro Diagnostic registration with the FDA and other agencies.
The incumbent will serve as a Medical and Scientific Affairs lead on at least one Life Cycle Team and as Clinical Science Lead on several individual Project Teams.
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 will work on collaborations with other units of Roche Diagnostics and Roche Pharma. This position is also the scientific and medical/clinical 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.
Serves as a medical leader at RMS, keeping the company abreast of advances in clinical medicine, health systems and public health which relate to infectious diseases.
Provides medical expertise and leadership to the Clinical Operations, Biometrics, Regulatory, Quality, Research, Development, Marketing and Business Development groups
Assists Research and Development Groups with assay design and the design of performance verification and troubleshooting experiments.
Identifies areas of unmet medical need for diagnostics. Devises the medical strategy for new products and articulates their potential medical value. Helps to identify and evaluate promising new biomarkers. Explores and defines potential clinical utility for company products.
Works with the Clinical Operations, Biometrics, and Data Management teams 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.
Defines potential clinical utility claims for products. Provides medical/scientific input into and assists with the preparation of PMA and 510(k) regulatory submissions. Prepares and provides responses to questions or requests for from regulatory agencies
Interfaces with other Life Cycle Teams and other diagnostics groups within Roche to ensure the coordinated development of point of care and central laboratory diagnostics.
Reviews product complaints to evaluate their potential clinical impact. Conducts medical reviews and provides medical opinions on complaints. Serves as a member of the Safety Board
Develops product specifications to ensure that products will be safe, effective and clinically useful. Reviews the late stage development programs for products to ensure that studies are designed and conducted to address any potential medical issues that arise from the performance or use of a product. Reviews results of studies conducted by the Development teams to ensure that products meet clinical requirements. Contributes to and reviews Instructions for Use to ensure that customers understand how to use the product safely and effectively.
Presents Clinical Research findings in meeting abstracts and publications. Identifies and advises opportunities to jointly promote Diagnostic and Pharmaceutical scientific and medical data, in collaboration with Roche and other pharmaceutical companies
Serves as company expert to prepare and/or give internal and external presentations and training on current and future company products and the disease areas in which those products are to be used
Consults with key medical opinion leaders in relevant therapeutic areas, and provides guidance on the planning and implementation of adviser meetings
Promotes individual development throughout the organization','You’re someone who wants to influence your own development. You’re looking for a company where you have the opportunity to pursue your interests across functions and geographies. ','Where a job title is not considered the final definition of who you are, but the starting point.','!*!Position Requirements:
MD, and/or PhD in microbiology, virology, or immunology
3 years of clinical research experience with a proven ability to design clinical trials, and critically evaluate study results. More experience is preferred. Ten years post-baccalaureate work experience
Thorough knowledge of clinical trial design and statistical methods for clinical research
Demonstrated ability to design studies, and write and review the resulting study reports and publications
Understanding of molecular, microbiology and virology laboratory techniques
Excellent organizational, communication, and project management skills
Ability to build and foster global relationships
Experience in interfacing with key opinion leaders including physicians and clinical laboratorians
Must be able to travel domestically and internationally 10-20%
5 years clinical experience in infectious diseases clinical care or in medical microbiology/virology. Board certification is a plus
Laboratory work experience, particularly in molecular biology, clinical microbiology or virology
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
Expertise in transplant virology
Expertise in global health
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','The next step is yours. To apply today, click on the Apply now button.','At Roche, 94,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.','At Roche, 94,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.','','','Roche is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, ','age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.','','','','','','','Medical Information/Scientific Affairs','US-USCA-Pleasanton','','Full-time','Regular Employee','Executive (Director/VP/SVP)','Diagnostics','Diagnostics','Director of Clinical Science, Infectious Diseases
F. Hoffmann-La Roche Ltd
Website : http://www.roche-diagnostics.co.in/Pages/default.aspx
The founding year – first successes F. Hoffmann-La Roche & Co. was founded at a time when industrial revolution was changing the face of Europe. On October 1, 1896, at the age of 28, Fritz Hoffmann-La Roche launched his company as the successor company to Hoffmann, Traub & Co in Basel, Switzerland. He was among the first to recognise that the industrial manufacture of medicines would be a major advance in the fight against disease. Since then, Roche has grown into one of the world's leading healthcare companies. First products Pharmacist Carl Schaerges, the first head of research, together with chemist Emil C. Barell demonstrate the presence of iodine in thyroid extracts. This results in Roche’s first patent and scientific publications. The launch of Aiodin marks the earliest in a series of thyroid preparations by Roche.