Reporting to the Chief Medical Officer, the VP of Clinical Operations leads resourcing, development, training and management of our clinical operations team to support multiple programs in various phases of development. The lead program in oncology has breakthrough and prime designation and is in Phase 3 with an EU marketing authorization and an accepted BLA submission in 2024. The lead program has early and late phase studies - both ongoing. Other programs include an early Phase program in NHL and SLE as well as pre-IND assets being actively evaluated. The individual works closely with CMO and cross functional department heads in establishing and adding to fit for purpose processes and governance.
Reports to: SVP, Chief Medical Officer
Location: Thousand Oaks, CA OR Remote
Primary ResponsibilitiesEnsures the effective and constructive integration of clinical operations knowledge and expertise into all applicable Clinical Development activities including integrated development plans and study protocols; interact and collaborate with other department heads as appropriate.Provides leadership, strategic oversight, and guidance of Clinical Operations to ensure quality, timeline, resources and budget goals are met.Creates, executes and proactively manage clinical trial Establishes performance indicators and apply to ensure the successful execution of clinical Represents all aspects of Clinical Operations and is an integral part of governance bodies such as development review committee.Leads and mentors clinical operations staff to support successful internal training and implementation and serves as an advocate for professional Develops Director/Sr. Director level leads for the various programs within clinical operations.Oversees, plans and implements quality checks for clinical projects and provides leadership and direction to ensure the highest standards for compliance with company SOPs, ICH-GCP guidelines, regulatory authority regulations and patient safety standards.Mentors clinical operations staff on the Regulatory Inspections process and develops a pro- active approach for Inspection readiness.Assists the QA department in the development, review and updating of clinical Develops and maintains strong relationships with CROs, external experts and Investigators to ensure effective execution of internal and external clinical projects.Coordinates with Biometrics to deliver high quality data deliverables on time and on budget (e.g. development of case report forms, collaboration with statisticians, collaboration with data managers, data overview, clinical study reports, etc.).Provides support for regulatory submissions, supporting dossier development and participating in interactions with FDA, EMA and other regulatory agencies.Keeps abreast of competitive regulatory and clinical practices and utilizes this knowledge during the ongoing development and adjustment of plans. Qualifications Bachelors in life or health care sciences; advanced degree preferredA minimum of 12 years of experience in the areas of clinical operations development and strategic planning; autoimmune and/or oncology experience is preferred; developing, implementing, and leading early to late (pre IND to post marketing) stage clinical trials.In-depth understanding and experience across the clinical operations value chain with a track record of success in study planning, execution, data cleaning, database locking, study report generation and regulatory inspection.Therapeutic experience in hematology/oncology and autoimmune disease, coupled with experience with pivotal, global multi-site clinical trials is highly desirable.Experience with global drug development and with any one of NDA/BLA/MAA filing is Proactive approach to problem solving; strong communication skills and ability to lead by Role model for Atara Bio More about Atara Bio
We launched Atara Biotherapeutics in August 2012 to help patients with serious diseases and few therapeutic options. We are considered a leading off-the-shelf T-cell immunotherapy company (Nasdaq ATRA) developing novel treatments for patients with cancer, autoimmune and viral diseases.
Our mission – “Transform the lives of patients with serious medical conditions through pioneering science, teamwork, and a commitment to excellence.”
Our vision - “T-Cell Immunotherapy for every patient, any time.”
Atara offers a competitive benefits packages that includes medical/dental/vision benefits, life and disability, retirement and stock program, as well as a generous paid time off and wellness plan that supports the well-being of our staff. Visit www.atarabio.com/careers to learn more.
Atara Bio is an equal opportunity employer and makes employment decisions on the basis of merit and other lawful factors. In accordance with applicable law, the Company prohibits discrimination based on race, color, religion, creed, sex, gender (including pregnancy, childbirth or medical condition related to pregnancy or childbirth), gender identity, expression or dysphoria, marital status, age, national origin or ancestry, physical or mental disability, medical condition, genetic information, veteran status, caregiver status, sexual orientation, transgender status or any other classification protected by federal, state or local laws or because of the individual’s association with a member of a protected group or connection to an organization or group related to a protected group.
We comply with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Atara Bio in the United States.
Software Powered by iCIMS
www.icims.com