Clinical Development Lead Infectious Diseases and Immunology (Diagnostics)

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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.

Who we are

At Roche, more than 100,000 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 Diagnostics International in Rotkreuz is a leading provider of diagnostic systems solutions, and the largest manufacturer of fully automated in vitro diagnostic systems in Switzerland. We are more than 2’700 passionate colleagues from over 65 nationalities. Find out more about our site in Central Switzerland, here .

Besides extensive development and training opportunities, we offer flexible working options, 18 weeks of maternity leave and 10 weeks of gender independent partnership leave. Our employees benefit from multiple services on site such as child-care facilities, medical services, restaurants and cafeterias, as well as various employee events.

We believe in the power of diversity and inclusion, and strive to identify and create opportunities that enable all people to bring their unique selves to Roche.