South San Francisco
California, United States of America
Genentech is seeking a Clinical Scientist with relevant pharmaceutical/biotechnology industry drug development experience to join Genentech’s Research and Early Development (gRED) Early Clinical Development (ECD) OMNI Clinical Science group. The Clinical Scientist will have an opportunity to work across multiple disease areas while facilitating the clinical and regulatory aspects of early drug development within gRED ECD OMNI Clinical Science.
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 Clinical Scientist participates in the development of clinical strategies for assigned molecule(s)/indication(s) and is responsible for developing and ensuring effective and efficient execution of the Clinical Development Plan (CDP). gRED Clinical Scientists are expected to perform their responsibilities with some supervision from senior staff.
Is a standing member of the Clinical Science Team or ad hoc member of relevant sub-teams, and as such, may regularly present clinical data or enrollment status updates to the CST
Effectively represents Clinical Science (CS) on the Execution Teams of assigned molecule(s) or indication(s), and ensures cross-functional integration, coordination and alignment to enable effective and efficient CDP execution, including regular review and analysis of protocol deviations, authoring of study start-up documents required from Clinical Science, and review of all study documents requiring clinical expertise as identified by the Execution Team
May author, with guidance and in collaboration with Medical Writing, the first draft of any clinical sections of regulatory documents that support IND applications or on-going or concluded clinical trials including clinical trial protocols or any/all protocol amendments
Collaborates with cross-functional members in the creation of electronic Case Report Forms to support the clinical database
Responsible for the review, finalization, and updates of information/data entered into clinical trials registry
Authors the first draft of responses to inquiries from Health Authorities or sites
Is the primary point of contact for protocol-related study inquiries from either internal functional representatives, study site personnel, or CRO personnel
Identifies data-driven study-specific analyses
Contributes to clinical documentation of study execution including management of regulated documents, notes of clinical decisions, and study conduct that are considered permanent record
Trains study site personnel on protocol execution, including authoring the Protocol Overview section of the Site Initiation Visit training deck and supplemental training materials required with protocol amendments
Collaborates with the Visual Analytics Manager to tailor Spotfire’s clinical and safety data visualization to assigned studies.
Conducts medical data reviews and collaborates with Data Management to ensure all queries submitted to sites by Clinical Science have been appropriately addressed
Provides Clinical Science input into and review of updates or new SOPs and Guidance documents
Collaborates with Safety Science to identify and track any potential safety events within a given trial
Supports departmental goals and initiatives
2. QUALIFICATIONS & EXPERIENCE:
Advanced clinical/science degree preferred (PharmD, PhD, MSN, MPH, etc.)
Generally 4 or more years pharma/biotech industry experience or demonstrates relevant equivalent clinical or laboratory research experience
Generally at least 2 years experience with clinical trials
Has experience working in complex matrix setting(s)
Relevant therapeutic area experience preferred
Experience authoring clinical trial protocols and/or study results and conclusions
In-depth understanding of Phase I-II drug development
Experience working with the principles and techniques of data analysis, interpretation, and assessment of clinical relevance
Comprehensive understanding of product and safety profiles
Well-versed in medical aspects of GCP (Good Clinical Practice), ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use), FDA, EMEA, NICE and other relevant guidelines and regulations
Strong computer skills
Proven abilities to perform CS responsibilities with some supervision from more senior colleagues. Has demonstrated, through past experience, abilities to competently manage the majority of CS deliverables associated with assigned clinical studies
Has impeccable ethics. Demonstrates, or proven abilities to demonstrate, gRED values
Outstanding attention to detail
Developing business acumen; is aware of the multidisciplinary functions involved in a company’s drug development process, e.g., clinical operations, biostatistics, regulatory, commercial operations, etc. and can proactively integrate multiple perspectives into the clinical development process for best end-results
Excellent project management skills: can prioritize multiple tasks and goals and deliver them in a timely, on-target and high-quality manner within budget guidance
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
Outstanding written communication skills
Strong presentation skills: effective at summarizing and presenting the key considerations and decision-points
Excellent teamwork skills: knows how to complete deliverables by working effectively with colleagues; can effectively drive discussions and decisions toward desired end-results
A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 40 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. Genentech has multiple therapies on the market for cancer & other serious illnesses. Please take this opportunity to learn about Genentech where we believe that our employees are our most important asset & are dedicated to remaining a great place to work.
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Genentech is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status. For more information about equal employment opportunity, visit our Genentech Careers page.
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