The Immunology, Infectious Diseases and Ophthalmology (I2O) Discovery and Translational Area (DTA) of Roche Pharma Research and Early Development (pRED) is seeking a highly motivated Clinical Microbiologist to join the Antibiotic Translational Microbiology Group in Infectious Diseases, located in Basel, Switzerland.
The position will be within the Microbiology Hub, a joint effort of both Genentech Research and Early Development (gRED) and pRED for supporting the clinical microbiology needs of Antibiotics programs.
In this position, the selected candidate will play an active role in a diverse team of scientists involved in the development of novel anti-infective agents for the treatment of multi-drug resistant bacterial infections within a truly global team.
Key Responsibilities :
Perform and coordinate translational microbiology studies for building the package required for health authority submissions of new antimicrobial agents
Design, outsource, analyze and interpret results of microbiological studies, including but not limited to i) Determination of the antibacterial spectrum of activity through Minimal Inhibitory Concentration (MIC) testing, ii) Evaluation of the bacterial Killing kinetic and iii) Resistance assessment of the targeted pathogens versus the novel investigational antimicrobial agents
Oversee design and execution of global surveillance program for testing the investigational antibacterial drug against a population of recent clinical isolates that represent the target bacteria for indications being sought for regulatory approval.
Develop the strategy for antibacterial susceptibility test (AST) methodology and generation of provisional interpretive criteria (breakpoints).
Working with a CRO, establish validated susceptibility testing methods (e.g. micro dilution and disk diffusion) and provisional AST interpretive criteria to ensure the generation of precise, accurate, and reproducible results.
Working with protocol execution and clinical operation teams and clinical sites, ensure that the clinical sites and / or central labs have the appropriate methods, instrumentation, quality control, and documentation measures to conduct and report AST results in compliance with regulatory standards.
Generate detailed information on the mechanisms of resistance and the potential for cross-resistance for resistant isolates encountered during clinical studies.
Interpret and communicate results to teams / stakeholders as well as author or contribute to the authoring of study protocols, microbiology study reports, and regulatory communication document
Work collaboratively with the appropriate functions at Roche and Genentech to identify, evaluate, and select appropriate CRO(s) to conduct microbiological studies.
Be actively involved with setting the terms of the contracts and SOWs for microbiological studies.
Who you are :
You are a passionate scientist who wants to make a difference and the next step in the field of anti-infectives. You enjoy working in a dynamic environment and you are interested to collaborate with colleagues in a truly global team.
You are someone that wants to apply your clinical microbiology expertise to support development of molecules in the preclinical and clinical stage for delivering new antibiotic solutions to fight multidrug resistant pathogens.
A Ph.D. in Microbiology or equivalent and at least 5 years of relevant experience as a scientist in clinical microbiology applied to anti-infective agents in industrial or clinical settings
Experience in translational and clinical microbiology, performing in vitro assays for the assessment of antibiotics activity and resistance development in accordance to established guidelines (e.g. CLSI, EUCAST)
Experience with industry guidance (e.g. FDA, EMA) for developing, analyzing and presenting microbiology data required to build the in vitro preclinical package supporting IND and NDA of antimicrobial agents
Experience in working with CROs is a must and conducting observational studies is a plus
Ability to work in a Global organization, leveraging virtual working tools across multiple time zones
Team player with strong collaboration skills
Efficient presentation and communication skills
Encourages adoption of new approaches and demonstrates ongoing commitment to become more dynamic, agile and continuously improves
Fluent in English (both oral and written)
If you are proud of contributing and feel you have the dedication to teamwork and innovation that we are seeking, then Roche is the organization for you.
Every role at Roche plays a part in making a difference to patients’ lives. If you want work in a passionate team, make your mark & improve lives, apply now.