Lead Clinical Scientist

Genentech; San Francisco (CA); On-site; USD 141,000 - 262,000; Full time

Job summary

Genentech, part of Roche, seeks a Lead Clinical Scientist for its gRED Early Clinical Development organization on the South San Francisco campus. The role develops clinical strategies, executes the Clinical Development Plan for one or more molecules, and contributes to complex projects with limited supervision.

The individual will author and review study protocols, conduct medical data reviews, and collaborate across functions to present data in clear formats, driving efficient development

Qualifications

• Advanced clinical/science degree preferred (PharmD, PhD, MSN, MPH, etc.)
• 4+ years pharma/biotech industry experience
• Experience working in complex matrixed setting(s)
• Experience with cross-functional authoring of full clinical trial protocols
• In-depth understanding of drug development and data interpretation

Responsibilities

• Contributes as a standing member of the Clinical Science Sub-Team.
• Drives authoring, review and team decisions for study protocols, ICFs, and start-up documents.
• Conducts medical data review.
• Reviews protocol deviations regularly and analyzes findings.
• Acts as primary point of contact for protocol-related inquiries from internal and external sites.
• Collaborates to present study data in simplified/fit-for-purpose formats.

Skills

Cross-functional authoring

Data analysis

Drug development knowledge

Clinical trial protocols

Matrixed environment

Education

Advanced clinical/science degree

Job description

The Position

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.

Genentech’s Research and Early Development (gRED) Early Clinical Development (ECD) organization is responsible for developing and executing early development clinical strategies and plans to provide proof-of-concept data with respect to safety, efficacy, and the utility of biomarkers for gRED new molecular entities. The Lead Clinical Scientist participates in development of clinical strategies for assigned molecule(s)/indication(s) and is responsible for developing and effective and efficient execution of the Clinical Development Plan (CDP) for one or more molecules. Lead Clinical Scientists are expected to perform their responsibilities independently, have core knowledge of the CS function to enable increased participation in department level initiatives, and may contribute to complex projects with supervision.

The Opportunity:

Your responsibilities in this role will include:

• Contributes as a standing member of the Clinical Science Sub-Team.
• Drives authoring, review and team decisions required to develop study protocols, ICFs, and study start-up documents documents requiring clinical expertise.
• Conducts medical data review.
• Processes and conducts regular review and analysis of protocol deviations.
• Primary POC for protocol-related inquiries from internal colleagues and external sites.
• May author, in collaboration with relevant team members and/or support functions, clinical sections of regulatory documents, or responses to healthy authority (HA) or ethics committee inquiries
• Collaborates cross-functionally to develop simplified/novel/fit-for-purpose presentation of study data.

Who You Are:

• Advanced clinical/science degree preferred (PharmD, PhD, MSN, MPH, etc.)
• 4 or more years pharma/biotech industry experience preferred
• Has experience working in complex matrixed setting(s)
• Experience with cross-functional authoring full clinical trial protocols
• In-depth understanding of drug development
• Experience working with the principles and techniques of data analysis, interpretation, and assessment of clinical relevance

Relocation benefits are not available for this posting.

Onsite presence, on our South San Francisco campus, is expected for at least 3 days a week.

The expected salary range for this position based on the primary location of South San Francisco, California is $141,000- $261,800. 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

#LI-JD1

#ECD

Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.

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