Director / Senior Director, Clinical Sciences

Clinical Science Thousand Oaks, California South San Francisco, California

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 Summary
This role is instrumental in supporting the growth of Atara Bio's pipeline in immuno-oncology and hematology-oncology. The successful candidate has hands-on responsibility designing clinical trials to evaluate the efficacy, safety, clinical pharmacology, and pharmacokinetics of biologic and cellular immunotherapies, managing scientific collaborations with pre-eminent academic institutions and consultants, and participating in health authority interaction activities to support CMA/BLA submissions. 

Reports to:   VP, Clinical Sciences

Location:      Westlake Village, CA preferred, South San Francisco, CA potential.

  

Primary Responsibilities

  • Designs and optimizes immuno-oncology and biologic therapy clinical trials, including development of clinical protocols and amendments, investigator brochures, annual reports, abstracts, manuscripts and clinical study reports in collaboration with the clinical development team.
  • Serves as a medical monitor, including evaluation of the safety, pharmacology and efficacy in ongoing and completed studies in close collaboration with the clinical operations team.
  • As the medical lead of a study, responsible for ensuring data quality, summary and writing of clinical study reports in close collaboration with the clinical operations, biometrics and medical writing team.
  • Works on CMA and BLA submission documents.
  • Establishes and implements exploratory pharmacodynamic, predictive and prognostic biomarker plans in conjunction with staff, consultants and collaborators.
  • Interacts with study investigators, thought leaders, including advisory boards, academicians, and internal colleagues.
  • Ensures adherence to Atara Bio’sStandard Operating Procedures.
  • Maintains clinical and scientific awareness in area of expertise. 


Travel
- Travel may be required (up to 25%).

Physical Requirements
Subject to extended periods of sitting and/or standing, vision to monitor and moderate noise levels. Work is generally performed in an office or clinical environment. Car and airplane (see above) travel is an essential part of the job.


Professional Qualifications

  • Minimum of an M.D. or Ph.D., and advanced training in hematology, oncology, with immunology or similar experience preferred. Board certification is preferred.
  • Minimum 2 years of industry experience designing, leading and managing clinical studies in solid tumors, hematologic malignancies and preferably immuno-oncology. Title commensurate with experience.
  • Must have closed a clinical study and authored a clinical study report in industry. CMA/NDA/BLA experience a plus.
  • Demonstrated understanding of the drug development process.
  • Knowledge of Good Clinical Practices, FDA regulations and guidelines and applicable regulatory requirements.
  • Ability to effectively evaluate outside expert advice.
  • Ability to communicate and explain immunologic and oncologic technical issues to clinical, regulatory, biomarker, biostatistics, data management and manufacturing colleagues who may have a non-medical background.
  • Ability to work independently.
  • Experience working effectively in a fast-paced, team-based environment.
  • Strong clinical/scientific/technical skills.
  • Strong interpersonal capabilities.
  • Ability to anticipate and resolve problems effectively.
  • Strong verbal communication and technical writing skills.
  • Ability to present clearly using scientific and clinical terminology.
  • Strong interpersonal skills and the ability to communicate effectively with people in diverse and different settings.
  • Sound organizational skills.
  • Possesses sense of urgency; identifies challenges and problems and takes the initiative to identify solutions.
  • Motivates team members; fosters and nurtures teamwork.
  • Project management skills and focus on delivery of results.
  • Role model for Atara’s values of patients first, innovation, teamwork, community and mindset.


This position search is being managed by our search firm collaborators at BioSearch Recruiting.  Please contact Todd Fulscher todd@biosearchrecruiting.com if you are qualified and interested or know someone who might be qualified and interested you'd like to refer.

More About Atara Bio
Now in our sixth year, we’re proud of our team of 260+ Atarians co-located by design in South San Francisco (corporate headquarters) and Southern California (R&D and manufacturing headquarters in the northwest Los Angeles area) with a newly-established European headquarters in Zug, Switzerland. Atara also has a R&D site in the Denver, Colorado area and an office in New York City. Our Southern California hub is anchored by a new 90,000 sq. ft., state-of-the-art Atara T-Cell Operations and Manufacturing (ATOM) facility in Thousand Oaks, California.

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 all of us.”

The Company's off-the-shelf, 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, or tab-cel™ (formerly known as ATA129), is being developed for the treatment of patients with Epstein-Barr virus (EBV) associated post-transplant lymphoproliferative disorder (EBV+ PTLD) who have failed rituximab, as well as other EBV-associated hematologic and solid tumors, including nasopharyngeal carcinoma (NPC). Tab-cel™ 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).

Atara is also developing off-the-shelf, allogeneic ATA188 and autologous ATA190 T-cell immunotherapies using a complementary targeted antigen recognition technology for 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 is also advancing a Phase 1 clinical study of ATA188 in patients with progressive or relapsing-remitting MS across clinical sites in the United States and Australia. Atara's clinical pipeline also includes ATA520 targeting Wilms Tumor 1 (WT1) and ATA230 directed against cytomegalovirus (CMV).

 

Working at Atara Bio
People 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. 

 

This position search is being managed by our search firm collaborators at BioSearch Recruiting.  Please contact Todd Fulscher todd@biosearchrecruiting.com  if you are qualified and interested or know someone who might be qualified and interested you'd like to refer.
More About Atara Bio.