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 new molecular entities. The role participates in the development of clinical strategies for assigned molecules and indications, and is responsible for developing and ensuring effective and efficient execution of the Clinical Development Plan (CDP). Responsibilities include:
Acts as a standing member of the Clinical Science Team or ad hoc member of relevant sub-teams and may regularly present and lead discussion of clinical data updates
Effectively represents Clinical Science on the Execution Teams of assigned molecule(s)/indication(s), and helps ensure 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 and review of all study documents requiring clinical expertise
Contributes to clinical documentation of study execution including management of regulated documents, response to IRBs and Health Authorities, registry disclosures, and notes of clinical decisions and study conduct that are considered permanent record
Originates clarifications to protocols and the initial draft of protocol amendments, and ensures any protocol amendment and corresponding Informed Consent Forms are completed as meets study team needs
Authors in collaboration with a Medical Writer any clinical sections of regulatory documents that support on-going or concluded clinical trials
Contributes to eCRF development and conducts medical data reviews, including collaborating with Data Management to ensure all queries submitted to sites by Clinical Science have been appropriately addressed
Collaborates with the Visual Analytics team to tailor clinical and safety data displays to assigned studies
Trains study site personnel, including preparation of training decks and other materials, and acts as a first point of contact for protocol-related inquiries from internal colleagues and external sites, and addresses queries or triages as appropriate
Collaborates with Safety Science to identify and track any potential safety events within a given trial
We are seeking candidates with the following skills, abilities and experience. The level of the position will depend on the qualifications of the selected candidate.
Education and Experience
Advanced degree such as a PhD or PharmD; equivalent combination of relevant education and experience may also be considered
2+ years relevant pharma/biotech industry experience OR relevant equivalent clinical or laboratory research experience OR relevant advanced academic experience
Skills and Abilities
Outstanding written communication skills with the ability to understand technical content such as complex regulatory documents, biologic rationale and information related to the drug development process
Experience working with the principles and techniques of data analysis and interpretation
Strong computer skills
Outstanding attention to detail
Business acumen and excellent project management skills
Strong interpersonal, verbal communication and influencing skills with the ability to drive discussions and decisions toward desired end-results
Strong presentation skills with the ability to effectively summarize and present key considerations and decision-points
Excellent teamwork skills with the ability to complete deliverables by working effectively with colleagues
Demonstrated understanding of Phase I-II drug development
Working knowledge of the medical aspects of GCP, ICH, FDA, EMEA, NICE and other relevant guidelines and regulations
Experience publishing clinical trial results in peer-reviewed journals
Experience working in complex matrixed setting
Who We Are
Genentech, a member of the Roche group and founder of the biotechnology industry, is dedicated to pursuing groundbreaking science to discover and develop medicines for people with serious and life-threatening diseases. To solve the world's most complex health challenges, we ask bigger questions that challenge our industry and the boundaries of science to transform society. Our transformational discoveries include the first targeted antibody for cancer and the first medicine for primary progressive multiple sclerosis.
Diversity and Inclusion (D&I) are critical to the success of our company and our impact on society. We believe that by championing diversity of background, thought and experience, we can foster a sense of belonging and provide an environment where every employee feels valued, included, and able to contribute their best for the patients we serve. We’re focused on attracting, retaining, developing and advancing our people to their full potential by rewarding bold ways of thinking and integrating inclusive behaviors into every aspect of our work.
The next step is yours. To apply today, click on the "Apply for this job" 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.