Clinical Scientist/Lead Clinical Scientist

Genentech • Daly City, CA

2d • Onsite

About The Position

Genentech’s Research and Early Development (gRED) Early Clinical Development (ECD) organization is responsible for developing and executing strategies to provide proof-of-concept data with respect to safety, efficacy, and the utility of biomarkers for new molecular entities. Clinical Scientists play a central role in the development of assigned molecule(s)/indication(s) and are responsible for supporting effective and efficient execution of the Clinical Development Plan (CDP).
The Opportunity:
Protocol Leadership: 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).
Cross-Functional Integration: 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.
Medical Data Oversight: 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.
Regulatory & Scientific Writing: 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.
Study Team Training: Serve as the subject matter expert to train internal teams and external site personnel on protocol requirements, medical nuances, and execution standards.
Strategic & Clinical Support: Support long-term therapeutic area strategy, including due diligence for in-licensing opportunities and the development of SOPs to improve clinical science workflows.
Quality & Compliance: 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.

Requirements

• 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.

Nice To Haves

• ophthalmology experience

Responsibilities

• lead the authoring and refinement of clinical protocols, ICFs, and study start-up documents
• Act as the primary Clinical Science POC for Execution Teams and sub-teams
• Execute rigorous medical data reviews and protocol deviation analyses
• Lead the development of clinical sections for regulatory filings (IND/NDA)
• Serve as the subject matter expert to train internal teams and external site personnel
• Support long-term therapeutic area strategy
• Maintain a high standard of trial documentation within the Trial Master File (TMF)

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Ph.D. or professional degree