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Clinical Development Lead, Infectious Disease and Microbiology

Hoffmann La Roche Ltd
Carlsbad, California, US
Closing date
Feb 1, 2022

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Basic Functions and General Scope: The Clinical Development Lead, Infectious Disease, provides clinical guidance for the development of new laboratory diagnostic products in the areas of infectious diseases and microbiology at GenMark Diagnostics. The lead will provide support for: (1) pre-market activities (e.g., identify unmet needs for new products, define their clinical requirements, contribute to early research and development, and lead the validation strategy to register these products as In Vitro Diagnostics with regulatory agencies) and (2) post-market compliance activities (e.g., document health hazard evaluations to support complaint handling process). Remote working is available with the expectation to travel as needed to the corporate facility (in Carlsbad, California, USA) or other Roche sites, as required. The position will report to the Head of Clinical Development, Infection and Immunity, in the Clinical Development and Medical Affairs department. The incumbent is expected to function as a leader of matrixed teams and to mentor and supervise the work of junior members of the department and to foster individual development throughout the organization. Specific Responsibilities: * Serves as a medical leader and expert at GenMark, keeping the company abreast of advances in clinical medicine, health systems and public health relating to infectious diseases and microbiology, and connects the company to external experts and stakeholders. * Identifies areas of unmet medical need for new multiplex molecular diagnostics. * Leads exploratory studies to guide product development and generate intellectual property. * Defines potential clinical utility claims for products. Provides medical/scientific input into and assists with the preparation and support of regulatory submissions. * Assists Research and Development Groups during product development. Reviews the data from these experiments from a clinical perspective. * Collaborates on establishing product specifications that ensure products will be safe, effective, and clinically useful. Successfully work cross-functionally to maximize utilization of scientific and medical content between Scientific Affairs, R&D, Clinical, Marketing and Sales. * Works with Clinical Affairs to design, implement, interpret, report and publish clinical research and/or clinical performance studies to support regulatory registrations. * Presents research findings in meeting abstracts and publications. * Provides clinical expertise for medical risk and safety assessments. * Responsible for the review of Medical Risk Assessments, per ISO 14971, which assess the impact to patients under hypothetical product malfunction scenarios. * Assess documents in the technical files to be submitted to European regulators under IVDR (In Vitro Diagnostics Regulation), particularly clinical performance and scientific validity reports. * Evaluate and interpret insights in the scientific and medical space; provide feedback on clinical and medical utility, which would be relevant to product portfolio. * Conduct peer to peer scientific discussions and data review Position Requirements: * MD, and/or PhD in microbiology, virology, infectious disease, molecular biology or a related Life Science discipline. * 1+ years of clinical microbiology and/or laboratory medicine experience in infectious diseases. * Understanding of laboratory techniques in infectious diseases in at least one of the following areas (more are preferred): PCR, sequencing, serology, microbiology, clinical virology. * Proven ability to design clinical studies, critically evaluate study results, and write protocols, study reports and publications. * Excellent organizational, communication, and project management skills. * Experience interfacing with key opinion leaders including physicians and clinical laboratorians. * Ability to respond effectively to sensitive inquiries, customer inquiries or complaints as well as communicate effectively both orally and in writing with management, peers and individuals Preferred: * Expertise in epidemiology, biostatistics, implementation science or other aspects of public health. * 3+ years of experience within the diagnostics or medical device industry with an understanding of the product development process, regulatory processes, and a track record of regulatory approval based on clinical trials. * Expertise in one or more of the following clinical areas: (a) respiratory infections; (b) sepsis; (c) hepatitis; (d) gastrointestinal infections; (e) sexually transmitted infections. 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. If you have a disability and need an accommodation in connection with the on-line application process, please email us at Job Level: Individual contributor

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