Develops and maintains effective, collaborative relationships with study teams, scientific function key stakeholders, data groups, internal outsourcing contacts, and CROs.
Applies relevant regulatory compliance and internal business standards in the performance of job responsibilities (e.g. eTMF, RACT, Maintenance of Study Tracking Documentation).
Assists function with outside spend (PVC) budget planning and management of actual spend (invoices, PO) for studies.
May work with pharmacology sub-teams to provide input on PK/ADA deliverable timing, PVC input during PAR team review, and to understand clinical program development direction (filings, new studies) to ensure program needs are met.
May assist with training and participate on organizational initiatives to support business needs.
Participates in study start-up, conduct, and close out activities including but not limited to the following:
Authors and reviews relevant section of study related documents (i.e., central lab SOWs, study protocols/ICFs, bioanalytical reports, etc.).
Develops study-specific sample and data flows plans with stakeholders (e.g. BAMP).
Harmonizes sample collection and handling instructions per bioanalytical strategies and assay requirements to ensure they are included in clinical site lab manual.
Facilitate resolution of sample and data discrepancies and disposition of samples throughout the study lifecycle.
Develops and manages timelines for bioanalytical labs to ensure samples are tested according to protocol and data is transferred in the Roche specified format per study team timelines.
Contributes to identification of bioanalysis CROs and set up of contracts for bioanalysis, working with internal contacts.
Through CRO Central Point of Contact (CPoC), manage CRO deliverables and performance, ensuring all deliverables are met per SOWs and study timelines. Provide input on CRO performance, escalating concerns as appropriate.
Education and Experience Requirements:
Bachelor’s degree or higher in biology, chemistry, or related scientific discipline. Project management certification desirable.
8-11 years of professional experience in pharmaceutical or biotechnology industry that includes experience related to bioanalysis and sample handling, CRO management, and/or clinical development/operations.
Working knowledge of ICH GCP.
Highly effectively verbal and written communication
Ability to make sound decisions with limited information in a changing landscape, influence, and negotiate effectively, using appropriate judgement
Highly motivated and proactive in performing work independently with problem-solving mindset
Demonstrated evidence of successful collaboration and delivery of results in a highly matrixed organization, working with culturally and geographically diverse teams.
Excellent organization and project management skills with high attention to detail to independently manage multiple projects with competing priorities
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.