Clinical Development Lead Infectious Diseases and Immunology

vor 3 Wochen

Rotkreuz, Schweiz F. Hoffmann-La Roche Gruppe Vollzeit

Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche, where every voice matters.

The Position

We advance science so that we all have more time with the people we love.

At Roche Diagnostics Solutions (RDS), we currently have a fantastic opportunity for a Clinical Development Lead to support our infectious diseases and immunology portfolio. This position will report to the Head of Clinical Development, Infection and Immunity, in the Clinical Development and Medical Affairs department and will lead matrixed project teams, mentor junior members of the department and foster individual development throughout the organization. This role can be based in Rotkreuz (Switzerland) or Penzberg (Germany) with reasonable flexibility regarding remote work.

In this position, you will be a part of a highly impactful global team that helps Roche understand what is needed in the clinic so we can "do now what patients need next." You will have the opportunity to work on a variety of projects, in most cases spanning multiple technologies, with an excellent success rate.

THE OPPORTUNITY

  • 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.

  • Assists 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.

  • Develops product specifications to ensure that products will be safe, effective and clinically useful; Provides clinical expertise for medical risk and safety assessments.

  • Works 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; Presents research findings in meeting abstracts and publications.

WHO YOU ARE

  • Medical Doctor (MD) with clinical experience in infectious diseases clinical care or in medical microbiology/virology/immunology. Board certification is a plus. PhDs with extensive clinical laboratory experience will also be considered.

  • Experience 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. Experience interfacing with key opinion leaders including physicians and clinical laboratorians is useful for this position.

  • At least 2 years of clinical research experience, with thorough knowledge of clinical trial design and statistical methods for clinical research. Proven ability to design clinical trials, critically evaluate study results, and write protocols, study reports and publications.

  • Understanding of laboratory techniques in infectious diseases in at least one of the following areas: PCR, sequencing, serology, microbiology, clinical Virology.

  • Expertise in epidemiology, biostatistics, implementation science or other aspects of public health is a plus.

  • Experience with near-patient testing and with diagnostics in low and middle income countries is preferred.

  • Excellent organizational, communication, and project management skills.

Ready to Make a Difference?

Join us at Roche Diagnostics Solutions (RDS) as a Clinical Development Lead in Infection and Immunity and help us advance science to improve lives. If you are passionate about making a global impact in infectious diseases and immunology, we want to hear from you. Apply now and be a part of a team dedicated to doing now what patients need next.

#J-18808-Ljbffr

  • Clinical Development Lead Infectious Diseases and Immunology

    vor 3 Wochen

    Rotkreuz, Schweiz F. Hoffmann-La Roche Gruppe Vollzeit

    Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche,...

  • Clinical Development Leader

    vor 1 Monat

    Rotkreuz, Schweiz ITech Consult Vollzeit

    Clinical Development Leader (m/f/d) – Neuroscience / Neurology / IVDR/FDA / Clinical study Design/ Clinical Science / Agile / English Project:For our customer Roche Diagnostics International AG based in Rotkreuz, we are looking for a highly qualified Clinical Development Leader (m/f/d). Background: Within Clinical Development, clinical expertise and...

  • Clinical Development Leader

    vor 1 Monat

    Rotkreuz, Schweiz ITech Consult Vollzeit

    **Clinical Development Leader (M/F/d) - Neuroscience /** **Neurology /** **IVDR/FDA / Clinical study Design/ Clinical Science /** **Agile / English** **Project**: For our customer Roche Diagnostics International AG based in Rotkreuz we are looking for a highly qualified Clinical Development Leader (M/F/d). **Background**: Within Clinical Development...

  • Principal Medical Science Director

    vor 3 Wochen

    Rotkreuz, Schweiz F. Hoffmann-La Roche Gruppe Vollzeit

    Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche,...

  • Scientist Lab Technician Assay Development

    vor 5 Monaten

    Rotkreuz, Schweiz Work Selection Vollzeit

    **Beschreibung**: For our international medical partner, Roche Diagnostics Int Ltd. based in Rotkreuz, we are looking for a qualified and motivated **Scientist Lab Technician Assay Development** for one year with option for extension. The Assay Development team is responsible for the development of molecular diagnostic and screening tests based on PCR...

  • Scientist Lab Technician Assay Development Specialist

    vor 1 Monat

    Rotkreuz, Zug, Schweiz Gi Group SA Vollzeit

    Job Title: Scientist Lab Technician Assay DevelopmentWe are seeking a highly skilled and motivated Scientist Lab Technician Assay Development to join our team at Roche Diagnostics in Rotkreuz, Switzerland.About the Role:The Assay Development team is responsible for the development of molecular diagnostic and screening tests based on PCR technology in the...

  • Molecular Diagnostic Test Developer

    vor 2 Monaten

    Rotkreuz, Zug, Schweiz Gi Group SA Vollzeit

    About the RoleWe are seeking a highly skilled and motivated Scientist Lab Technician Assay Development to join our team at Roche Diagnostics in Rotkreuz, Switzerland.Key ResponsibilitiesDevelop molecular diagnostic and screening tests based on PCR technology in the areas of infectious diseases, genomics, and oncology.Collaborate with cross-functional teams...

  • Scientist Lab Technician Assay Development

    vor 5 Monaten

    Rotkreuz, Schweiz Work Selection Vollzeit

    **Beschreibung**: For our international medical partner, Roche Diagnostics Int Ltd. based in Rotkreuz, we are looking for a qualified and motivated **Scientist Lab Technician Assay Development** for one year with option for extension. The Assay Development team is responsible for the development of molecular diagnostic and screening tests based on PCR...

  • Senior Molecular Diagnostic Specialist

    vor 3 Wochen

    Rotkreuz, Zug, Schweiz Gi Group SA Vollzeit

    Job SummaryWe are seeking a highly skilled and motivated Senior Molecular Diagnostic Specialist to join our Assay Development team. The successful candidate will be responsible for the development of molecular diagnostic and screening tests based on PCR technology in the areas of infectious diseases, genomics, and oncology.Key ResponsibilitiesPerform root...

  • Scientist Lab Technician Assay Development Specialist

    vor 3 Wochen

    Rotkreuz, Zug, Schweiz Gi Group SA Vollzeit

    About the RoleWe are seeking a highly skilled and motivated Scientist Lab Technician Assay Development to join our team at Roche Diagnostics in Rotkreuz, Switzerland.Key ResponsibilitiesPerform root cause analysis and troubleshoot product care casesWork with high-throughput lab-analyzers and lead own experimentsConduct routine lab work with infectious...

  • Lab Technician Assay Development Expert

    vor 2 Monaten

    Rotkreuz, Zug, Schweiz Gi Group SA Vollzeit

    About the RoleWe are seeking a highly skilled and motivated Scientist Lab Technician Assay Development to join our team at Gi Group SA. As a key member of our Assay Development team, you will be responsible for the development of molecular diagnostic and screening tests based on PCR technology.Key ResponsibilitiesRoot Cause Analysis: Perform root cause...

  • Scientist

    vor 5 Monaten

    Rotkreuz, Schweiz Work Selection Vollzeit

    **Beschreibung**: For our international medical partner, Roche Diagnostics Int Ltd. based in Rotkreuz, we are looking for a qualified and motivated **Scientist **for one year with option for extension. The Assay Development team is responsible for the development of molecular diagnostic and screening tests based on PCR technology in the areas of infectious...

  • Solution Train Engineer/ System Development Lead

    vor 1 Monat

    Rotkreuz, Zug, Schweiz Roche Vollzeit

    About the RoleThe PositionWe are seeking a highly skilled Solution Train Engineer/ System Development Lead to join our team at Roche Information Solution India. As a critical leadership role in the SAFe framework, you will be responsible for guiding and supporting multiple Agile Release Trains (ARTs) to deliver large and complex solutions.About the TeamRoche...

  • Scientist Lab Technician Assay Development

    vor 5 Monaten

    Rotkreuz, Schweiz Work Selection Vollzeit

    **Beschreibung**: For our international medical partner, Roche Diagnostics Int Ltd. based in Rotkreuz, we are looking for a qualified and motivated **Scientist Lab Technician Assay Development** for one year with option for extension. **Tasks**: - Working with high throughput lab - analyzer - Routine lab work with infectious samples and leading of own...

  • International Healthcare Quality Improvement Consultant

    vor 2 Wochen

    Rotkreuz, Schweiz F. Hoffmann-La Roche Gruppe Vollzeit

    Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche,...

  • Scientist Lab Technician Assay Development

    vor 5 Monaten

    Rotkreuz, Schweiz Work Selection Vollzeit

    **Beschreibung**: For our international medical partner, Roche Diagnostics Int Ltd. based in Rotkreuz, we are looking for a qualified and motivated **Scientist Lab Technician Assay Development** for one year with option for extension. **Tasks**: - Working with high throughput lab - analyzer - Routine lab work with infectious samples and leading of own...

  • Clinical Research Associate

    vor 5 Monaten

    Rotkreuz, Schweiz ITech Consult Vollzeit

    **Clinical Research Associate I (M/F/d) GCP / FDA / IVD directives / clinical studies / English** **Project: For our customer Roche Diagnostics International AG based in Rotkreuz we are looking for a qualified Clinical Research Associate I (M/F/d)** **Background**: The Clinical Research Associate will design, plan, coordinate, and conduct all activities...

  • International Healthcare Quality Improvement Consultant

    vor 3 Wochen

    Rotkreuz, Schweiz F. Hoffmann-La Roche Gruppe Vollzeit

    Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche,...

  • Solution Train Engineer/ System Development Lead

    vor 5 Monaten

    Risch-Rotkreuz, Schweiz Roche Vollzeit

    The Position About the role  NAVIFY Algorithm Suite is a Roche-built software application which is hosted on the NAVIFY platform and designed to enable and consolidate individual (or group of) clinical high medical value algorithms, all in a one unique access point integrated to our customer network be it LIS or EMR. For Roche Information Solution...

  • Global Study Lead

    vor 6 Stunden

    Rotkreuz, Schweiz F. Hoffmann-La Roche AG Vollzeit

    Global Study Lead - Diagnostics (m/f/d)Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a...