At Roche you can show up as yourself embraced for the unique qualities you bring. Our culture encourages personal expression open dialogue and genuine connections where you are valued accepted and respected for who you are allowing you to thrive both personally and professionally. This is how we aim to prevent stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche where every voice matters.

The Position

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

Join us as aClinical Operations LeadatRoche/Genentechand be part of our bold vision to deliver 20 transformative medicines addressing diseases with the highest societal burden. Our mission inPharma Product Development (PD) Global Clinical Operations (PDG)is to revolutionize how we work always placing the patient at the center.

We are looking for a Clinical Operations Lead focused onbiomarker operations. You will be responsible and accountable for providing biomarker operational expertise planning coordinating and overseeing all operational activities for the lifecycle of biomarker and companion diagnostic samples and data for PDG clinical studies.

The Position

• Offer biomarker/IVD operational expertise to clinical study teams to ensure feasibility and quality data delivery.

• Accountable for the development of the Biomarker Management Plan and executing deliverables for assigned drug and device studies in partnership with the Clinical Study Lead or designee.

• Oversee all studylevel biomarker operations activities for both clinical (drug) and IVD studies including vendor/testing sites management ICF/protocol input eTMF/RACT setup sample/data flow data quality and transfer setup biomarker analysis timelines risks compliance ensuring adherence to ICH/GCP SOPs ISO 20916 and regulatory requirements.

• Collaborate with internal/external partners in the central lab setup providing sample collection and processing instructions shipping conditions and logistics for biomarker samples.

• Lead the identification selection and oversight of biomarker vendors including development and oversight of scope of work budgets ensuring quality delivery and performance.

• Identify areas of best practice and process improvements and contribute to/lead initiatives as required.

Who You Are

You are a talented and passionate individual driven by our shared purpose to innovate clinical trial delivery. Your principles include:

• CustomerCentricity:You prioritize patient and site needs fostering a culture of helpfulness influencing and motivating growth and innovation.

• Growth Mindset:You embrace learning and encourage others to learn embracing new experiences and risks.

• Enterprise View:You champion the greater good appreciating enterpriselevel tradeoffs and resource implications.

• Diversity Equity & Inclusion:You advocate for a diverse and inclusive work environment ensuring everyone can contribute and influence.

You are skilled in organizing problem solving planning and managing clinical operations efficiently with transparent and strategic communication and effective listening. Whether leading or participating in diverse teams you inspire others and embody Roches Leadership Framework principles of Visionary Architect Catalyst and Coach (VACC).

Technical Expertise

• Education:Minimum Bachelor/Master in Life Sciences (Scientific Medical or Healthcare subject area). A PhD and/or project management certification is desirable.

• Experience:3 years of experience in a clinical research setting clinical/diagnostic laboratory or pharmaceutical/biotechnology R&D environment.

• Clinical Development:Extensive clinical development experience with evidence of working in teams running clinical studies.

• Vendor and Project Management:Strong experience with vendor and project management.

• Regulatory Knowledge:Strong knowledge of drug development processes and respective regulations including ICH and GCP guidelines.

• Laboratory Experience:Clinical or laboratory experience with involvement in the processing and/or analysis of biological samples.

Who we are

A healthier future drives us to innovate. Together more than 100000 employees across the globe are dedicated to advance science ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities foster creativity and keep our ambitions high so we can deliver lifechanging healthcare solutions that make a global impact.

Lets build a healthier future together.

Basel is the headquarters of the Roche Group and one of its most important centres of pharmaceutical research. Over 10700 employees from over 100 countries come together at our Basel/Kaiseraugst site which is one of Roches largest sites. Read more.

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 also benefit from multiple services on site such as childcare facilities medical services restaurants and cafeterias as well as various employee events.