Clinical Development Lead, Infection and Immunity - Hiring Fast

pTitle: Clinical Development Lead, Infection and Immunitybr /Category: Medical/Clinical Affairsbr /br /strongLocation:nbsp;/strongOpen to remote, must be in United Statesbr /strongPay rate range: /strong$ 45.91 - $100 -Health, Dental, Vision, 401kbr /br /strongBasic Functions and General Scope:/strongbr /br /The Clinical Development Lead, Infection and Immunity, provides clinical guidance for the development of new laboratory and digital diagnostic products in the areas of infectious diseases and immunology at Roche Diagnostic Solutions (RDS). The lead identifies unmet needs for new products, defines their clinical requirements, contributes to early research and development, and, as the clinical leader on cross-functional project teams, leads the clinical development and validation strategy to register these products as In Vitro Diagnostics with regulatory agencies.br /br /This position may be based out of Pleasanton, California, USA, with remote work locations possible. The position will report to the Head of Clinical Development, Infection and Immunity, in the Clinical Development and Medical Affairs department. There will not be positions reporting administratively into this role, but 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.br /br /strongSpecific Responsibilities:/strong/pulliServes as a medical leader and expert, keeping the company abreast of advances in clinical medicine, health systems and public health relating to infectious diseases and immunology, and connects the company to external experts and stakeholders./liliIdentifies areas of unmet medical need for diagnostics./liliLeads exploratory studies to guide product development and generate intellectual property./liliDefines potential clinical utility claims for products. Provides medical/scientific input into and assists with the preparation of regulatory submissions. Provides responses to regulatory agency questions./liliAssists Research and Development Groups with target product profiles and design choices. and the design of performance verification and troubleshooting experiments. Reviews the data from these experiments from a clinical perspective./liliDevelops product specifications to ensure that products will be safe, effective and clinically useful./liliWorks with Clinical Operations 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./liliPresents research findings in meeting abstracts and publications./liliProvides clinical expertise for medical risk and safety assessments./li/ulpbr /br /strongPosition Requirements:/strong/pulliGraduate work in microbiology, virology, or immunology; Completion of an MD and/or PhD preferred./lili1+ years of clinical research experience, with thorough knowledge of clinical trial design and statistical methods for clinical research. More experience is preferred./liliProven ability to design clinical trials, critically evaluate study results, and write protocols, study reports and publications./liliUnderstanding of laboratory techniques in infectious diseases in at least one of the following areas (more are preferred): PCR, sequencing, serology, microbiology, clinical virology./liliExcellent organizational, communication, and project management skills./liliExperience interfacing with key opinion leaders including physicians and clinical laboratorians./li/ulpbr /strongPreferred:/strong/pulli3+ years clinical experience in infectious diseases clinical care or in medical microbiology/virology. Board certification is a plus./liliLaboratory work experience./liliExpertise in epidemiology, biostatistics, implementation science or other aspects of public health./liliExperience within the diagnostics, medical device or pharmaceutical industry, with an understanding of the product development process, regulatory processes, and a track record of regulatory approval based on clinical trials./liliExperience with the development of clinical software./liliExpertise in one or more of the following clinical areas: (a) immunocompromised host, HIV, transplant; (b) sepsis; (c) hepatitis; (d) respiratory infections; (e) clinical immunology./li/ul