Atara Biotherapeutics, Inc.
We launched Atara Biotherapeutics in August 2012 to help patients with serious diseases and few therapeutic options. We’re named after Atara Ciechanover who suffered from cancer before passing away. 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.Position SummaryThis role is responsible, from the clinical data perspective, for the preparation and execution of clinical trials from database development through clinical study reports. The role ensures completion of all study data deliverables, and proactively identifies and resolves clinical data/database issues and participates in process improvement initiatives as required.Reports to Associate Director, Clinical Data ManagementLocation Westlake Village (northwest Los Angeles area), CA preferred or South San Francisco, CA Primary Responsibilities:Manages data management projects, products and/or Therapeutic Areas.Manages data activities for all clinical trials (Phase I - IV) as well as the design, review, and validation of the clinical database to deliver data for analysis and submission as part of a regulatory filing.Designs case report forms (CRFs) as well as data edit checks and aggregate check specifications with CROs. Will oversee the development of any clinical database by the EDC/CRO vendor, and will manage the sponsor user acceptance testing of the clinical database.Works in coordination with statisticians and programmer/analysts.Works in coordination with clinical research and development, clinical operations, and CROs to develop study documents including the study protocols, (CRFs), and CRF instructions.Serves as the primary interface with CROs for any data management related activities. Ensures that data management tasks remain on target according to study timelines and requirements.Proactively works with CROs to organize on-going data review throughout the study to ensure timely identification and correction of errors or discrepancies. Routinely communicates site data concerns/issues with clinical operations team and CROs in order to ensure collaboration toward resolution.Ensures delivery of a quality locked database for analysis at the close of studies.Travel Travel may be required (up to 25%).Physical RequirementsSubject to extended periods of sitting and standing, vision to monitor and moderate noise levels. Work is generally performed in an office or clinical environment. Car and airplane (see above) travel may be an essential part of the job. Professional QualificationsRequiredBachelor's degree or equivalent combination of education/experience in math, science or health-related field.Minimum of 5-8 years of clinical trial data management experience in a Pharmaceutical/Biotech environment with 2-5 years of clinically relevant therapeutic experience.Manager minimum = 5 yearsSr Manager minimum = 8 yearsStrong understanding of clinical trial process and EDC platforms.Experience with data programming tools and/or data viewing tools (J-Review, SAS JMP.etc).Excellent communication and organizational skills, along with problem solving, conflict resolution, leadership and team-building skills.Role model for Atara’s Values of patients first, innovation teamwork, community and mindset.PreferredOncology, Neuro and Nephrology experience.Global trial experience.Smaller bio-oncology company experience.Immuno-Oncology experience a plus.More About Atara BioNow in our sixth year, we’re proud of our team of 180 Atarians co-located at Westlake Village, CA (northwest Los Angeles area) and South San Francisco, CA, with a process development lab in the Denver, CO area at the Fitzsimons Innovation Center and an office in New York City. We’ll be bringing on our new cell therapy plant and office in Thousand Oaks (near Westlake Village) in Q2 and moving the Westlake Village team over to the new facility.One mission - Transform the lives of patients with serious medical conditions through pioneering science, teamwork and expertise – and a singular vision - Cell therapy treatment for every patient, any time – provide inspiration and direction for us all.Originating from over a decade of groundbreaking clinical experience at Memorial Sloan Kettering and QIMR Berghofer, Atara’s off-the-shelf, or allogeneic, T-cells are bioengineered from donors with healthy immune function and allow for rapid delivery from inventory to patients without a requirement for pretreatment. Atara’s T-cell immunotherapies are designed to precisely recognize and eliminate cancerous or diseased cells without affecting normal, healthy cells.Atara’s most advanced T-cell immunotherapy in development, tabelecleucel (formerly known as ATA129), is being developed for the treatment of patients with rituximab-refractory Epstein-Barr virus (EBV) associated post-transplant lymphoproliferative disorder (EBV PTLD), as well as other EBV associated hematologic and solid tumors, including nasopharyngeal carcinoma (NPC).Tabelecleucel is in Phase 3 clinical development for the treatment of EBV PTLD following an allogeneic hematopoietic cell transplant (MATCH study) or solid organ transplant (ALLELE study), and a Phase 1/2 study of tabelecleucel in combination with Merck’s anti-PD-1 (programmed death receptor-1) therapy, KEYTRUDA® (pembrolizumab), in patients with platinum-resistant or recurrent EBV associated NPC is planned for 2018. Tabelecleucel is also available to eligible patients with EBV associated hematologic and solid tumors through an ongoing multicenter expanded access protocol (EAP) clinical study.Off-the-shelf ATA188 and autologous ATA190, the Company’s T-cell immunotherapies using a complementary targeted antigen recognition technology, target specific EBV antigens believed to be important for the potential treatment of multiple sclerosis (MS). A Phase 1 clinical study of autologous ATA190 in patients with progressive MS is ongoing. Atara also initiated a global Phase 1 ATA188 clinical study in patients with progressive or relapsing-remitting MS in Australia in the fourth quarter of 2017 with patient enrollment at U.S. sites beginning in early 2018.Atara’s clinical pipeline also includes ATA520 targeting Wilms Tumor 1 (WT1) and ATA230 directed against cytomegalovirus (CMV).Working at Atara BioPeople at Atara Bio are high integrity, roll-up-your-sleeves, get-it-done types who are keenly committed to putting patients first, advancing medical care and doing so with demonstrated urgency. At their core Atarians are people who work well with others and are “team-centric”, have purposeful curiosity and can’t wait to save patient lives. And similar to other biotech companies who have so many accomplished people, we expect humility (we are a “low hubris” sort of place), flexibility, respect, teamwork, good judgment and getting the most out of any dollar we spend. We also expect to enjoy the journey (and each other) as we move forward with a shared responsibility to teach and to learn from what we do and from our teammates.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.
Atara Biotherapeutics, Inc.
Website : http://www.atarabio.com
We launched Atara Biotherapeutics in August 2012 to help patients combat cancer, kidney disease and other illnesses. Our research is based on groundbreaking discoveries regarding the ability of activin, myostatin and other growth factors to change the course of disease progression. Our goal is to help patients such as Atara Ciechanover, our company’s namesake, who suffered from cancer before passing away in 2012. We aim to empower patients to fight their illnesses with better treatment options.