Clinical Scientist/Lead Clinical Scientist jobs in United States
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Genentech · 2 days ago

Clinical Scientist/Lead Clinical Scientist

Genentech is a biotechnology company focused on developing innovative medicines. The Lead Clinical Scientist is responsible for leading clinical protocol development, ensuring effective communication across teams, and overseeing medical data analysis to support clinical trials.

BiotechnologyLife ScienceManufacturing
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Comp. & Benefits
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H1B Sponsor Likelynote

Responsibilities

Lead the authoring and refinement of clinical protocols, ICFs, and study start-up documents, ensuring scientific integrity and alignment with the Clinical Development Plan (CDP)
Act as the primary Clinical Science POC for Execution Teams and sub-teams, facilitating communication between Medical Monitoring, Biostatistics, and Clinical Operations to ensure seamless trial delivery
Execute rigorous medical data reviews and protocol deviation analyses, utilizing tools to visualize safety/efficacy trends and partnering with Data Management to resolve clinical queries
Lead the development of clinical sections for regulatory filings (IND/NDA), respond to Health Authority inquiries, and contribute to peer-reviewed publications and international conference presentations
Serve as the subject matter expert to train internal teams and external site personnel on protocol requirements, medical nuances, and execution standards
Support long-term therapeutic area strategy, including due diligence for in-licensing opportunities and the development of SOPs to improve clinical science workflows
Maintain a high standard of trial documentation within the Trial Master File (TMF) and collaborate with Safety Science to monitor and track potential safety signals

Qualification

Clinical protocol authoringData analysisInterpretationRegulatory writingGCP knowledgeInterpersonal skillsOphthalmology experienceTraining skillsCross-functional teamwork

Required

Advanced clinical/science degree (PharmD, PhD, MSN, MPH, etc.) with 0-3 years pharma/biotech industry experience (Clinical Scientist); 4+ years experience (Lead Clinical Scientist); ophthalmology experience a plus
Experience working in a matrix environment on cross-functional teams for authoring clinical trial protocols and other study-related documents, in depth experience with data analysis and interpretation, understanding of safety science, and writing manuscripts for peer-reviewed journals
Knowledge of medical aspects of GCP (Good Clinical Practice), ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use), FDA, EMEA, NICE and other relevant guidelines and regulations
Strong interpersonal, verbal communication and influencing skills: can influence without authority and is willing to cultivate relationships with key partners and stakeholders, both internally and externally
Ability to travel globally (<10%; variable based on project assignment)
Onsite presence, on our South San Francisco campus, is expected for at least 3 days a week

Benefits

Relocation benefits are available for this job posting.
A discretionary annual bonus may be available based on individual and Company performance.

Company

Genentech

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Genentech is a biotechnology research company that specializes in genetic testing and personalized medicines.

H1B Sponsorship

Genentech has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (167)
2024 (148)
2023 (150)
2022 (178)
2021 (121)
2020 (158)

Funding

Current Stage
Public Company
Total Funding
unknown
2009-03-26Acquired
1999-07-20IPO
1976-01-01Series Unknown

Leadership Team

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Ashley Magargee
Chief Executive Officer
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Michael Laird
Vice President, Global MSAT Drug Substance Biologics Technology and Commercial Products Support
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Company data provided by crunchbase