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Clinical Scientist Early Clinical Development

South San Francisco
California, United States of America


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The Position

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

ABILITIES:

  • 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

Who We Are

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.

The next step is yours. To apply today, click on the "Apply online" button.

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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