Medical Director Clinical Sciences - Neuroscience

Clinical Science Westlake Village (Los Angeles), California

Position Summary
This role is responsible for providing expert medical input to human clinical trials for Atara Bio products under development for multiple sclerosis and other conditions. The incumbent has hands-on responsibility for designing clinical trials to evaluate the efficacy, safety, clinical pharmacology, and pharmacokinetics of cellular immunotherapies, and also managing scientific collaborations with pre-eminent academic institutions and consultants.  As with all of our clinicians, interested candidates should have an interest and passion for work in all aspects of clinical drug development.

 

Location        Thousand Oaks (northwest Los Angeles area), CA or South 
                             San Francisco, CA

Reports to     Senior Director, Clinical Sciences


Primary Responsibilities

  • Designs and optimizes multiple sclerosis 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.
  • 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 Standard Operating Procedure (SOP) standards.
  • 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 

  • or M.D., Ph.D. with advanced training or significant experience in multiple sclerosis.  Board certification is preferred.
  • Demonstrated understanding of the drug development process.
  • Knowledge of Good Clinical Practices (GCP), FDA regulations and guidelines, and applicable regulatory requirements.
  • Ability to effectively evaluate outside expert advice.
  • Ability to communicate and explain medical issues to clinical, regulatory, biomarker, biostatistics, data management and manufacturing colleagues who may have a non-medical background.
  • Ability to manage and direct work independently as well as work effectively in Atara’s team-based environment.
  • Experience working effectively in a fast-paced, team-based environment.


Personal Qualifications

  • Strong leadership skills with an ability to set a vision, to lead change, and to lead and mentor others.
  • Ability to create and communicate a compelling sense of core purpose and ability to solicit opportunities and possibilities.
  • Ability to organize, structure and staff the organization in a rapidly changing environment.
  • Strong personal presence with ability to command respect through exercise of sound business judgment and clear decision-making.
  • Forward thinker with strong industry knowledge and an ability to identify, synthesize and act upon strategic information and changes within the environment.
  • Demonstrates a passion for and focus on results with an ability to create excitement and a sense of purpose.

 

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.