The Position
We advance science so that we all have more time with the people we love.
Genentech’s Research and Early Development (gRED) Early Clinical Development (ECD) organization is responsible for developing and driving 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 (E4A/SE6 level) 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:
Contributes as a standing member of the Clinical Science Sub-Team (CST), is an ad hoc member of the Core Team, and may represent CS on other relevant sub-teams. Presents and leads discussions relating to clinical data or protocol execution. Helps cross-functional team members synthesize/contextualize clinical data to facilitate discussion and decision making. May independently spearhead working groups and/or Subteam initiatives in support of protocol, disease area, or CDP.
Contributes to CDP and development of long-range strategy for assigned programs.
Drives authoring, review and team decisions required to develop study protocols, ICFs, and study start-up documents requiring clinical expertise (eg, development/updating of CRFs, supervising plans, study registry and disclosure etc.).
Conducts medical data review. Collaborates with the Visual Analytics Manager to tailor visualizations and summaries of Spotfire’s clinical and safety data required for ongoing medical data review. Collaborates with Data Management to ensure all queries submitted to sites by CS have been appropriately addressed.
Processes and conducts regular review and analysis of protocol deviations.
Drafts clarifications to protocols and protocol amendments as needed, and ensures any protocol amendments and corresponding ICFs and study related documents are completed/updated as needed.
Responsible for ensuring the completeness and quality of CS documents in the trial master files (TMF).
May mentor and/or train new Clinical Scientists, Interns, or Rotation candidates.
Supports or leads business and process improvement goals and initiatives and the development/maintenance of CS resources and procedural documents/SOPs.
Who You Are:
Advanced clinical/science degree preferred (PharmD, PhD, MSN, MPH, etc.) and 4 or more year's experience with clinical trials preferred.
In-depth understanding of drug development and experience working with the principles and techniques of data analysis, interpretation, and assessment of clinical relevance.
Comprehensive understanding of product and safety profiles.
Proficient in medical aspects of GCP (Good Clinical Practice) and ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use).
Has impeccable ethics, outstanding attention to detail and written communication skills.
Strong business acumen; has knowledge of the multidisciplinary functions involved in a company’s drug development process.
Excellent leadership and project management skills: can prioritize multiple tasks and goals and deliver them in a timely, on-target and high-quality manner within budget guidance.
Excellent interpersonal, verbal communication and influencing skills: can influence without authority and has proven experience building and cultivating relationships with key partners and stakeholders, both internally and externally.
Relocation benefits are not available for this job 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 California is $141,000 - $261,800 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
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.
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