Clinical Operations Lead

A healthier future. It's what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That's what makes us Roche.

Join us as a Clinical Operations Lead at Genentech and be part of our bold vision to deliver 20 transformative medicines addressing diseases with the highest societal burden. Our mission in Pharma Product Development (PD) Global Clinical Operations (PDG) is to redefine how we work, always placing the patient at the center.

We are looking for a Clinical Operations Lead focused on biomarker 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 Opportunity:

• 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 study-level biomarker operations activities for both clinical (drug) and IVD studies, including vendor/testing sites management, ICF/protocol input, eTMF/RACT set-up, sample/data flow, data quality, and transfer set-up.

• Collaborate with internal/external partners in the central lab set-up, 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.

• Actively partner with Data Management to oversee and coordinate biomarker data format and delivery timelines.

• Develop and oversee biomarker analysis timelines, budgets, risks, compliance, and quality, ensuring adherence to ICH/GCP, SOPs, ISO 20916, and regulatory requirements.

• Attend operations team meetings and investigator/monitor meetings to deliver presentations and in-depth training to stakeholders on biomarker and companion diagnostic sample collection, handling, and IVD procedures.

• Provide responses to biomarker sample/IVD related questions or issues from Health Authorities.

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

• Maintain ongoing and sustained onsite presence in compliance with local requirements.

Who You Are

• You have a Bachelor's in Life Sciences (Scientific, Medical or Healthcare or related field) with 3 years of proven experience OR a Masters in Life Sciences (Scientific, Medical, or Healthcare or related field with 1 year of proven experience

• You have 3+ years of demonstrated ability in a clinical research setting, clinical/diagnostic laboratory, or pharmaceutical/biotechnology R&D environment.

• You have extensive clinical development experience with evidence of working in teams running clinical studies.

• You have strong experience with vendor and project management.

• You have strong knowledge of drug development processes and respective regulations, including ICH and GCP guidelines.

• You have clinical or laboratory experience with involvement in the processing and/or analysis of biological samples.

• You have experience working in a global and matrix environment.

• You have excellent collaboration, communication, influencing, and presentation skills. Critical reasoning skills, diligent, ability to work independently, and lead multiple competing priorities.

The expected salary range for this position based on the primary location of San Francisco, CA is 125,100-232,300 of hiring range. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance.

This position also qualifies for the benefits detailed at the link provided below.

Benefits

Relocation benefits are not provided for this position

Genentech is an equal opportunity employer, and we embrace the increasingly diverse world around us. Genentech prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status.