Associate Medical Director/Medical Director - Clinical Sciences

Job Locations US-CA-Thousand Oaks | US-CA-South San Francisco
ID
2020-1308
Category
Clinical Development
Type
Regular Full-Time

Job Description

Title: Associate Medical Director/Medical Director

 

Position Summary:
This role supports the growth of Atara Bio's pipeline in immuno-oncology and hematology-oncology at the clinical trials level. In collaboration with clinical and project teams of the company, the successful candidate plans, designs, and executes clinical development research studies to evaluate the efficacy, safety, clinical pharmacology, and pharmacokinetics of biologic and cellular immunotherapies. The position is also on-point to initiate and manage scientific collaborations with pre-eminent academic institutions, investigators, and consultants, culminating in participation in interactions with health authorities to support CMA/BLA submissions. This role also serves as a critical internal resource for clinical science for a variety of functions needing clinical science input, ranging from pre-clinical to commercial.


Reports to:
 Vice President, Clinical Sciences

 

Location: Thousand Oaks (NW Los Angeles area), or South San Francisco, CA. Willing to consider remote basis.

 

Travel: Travel may be required (up to 25%)

 

Primary Responsibilities

  • Serves as the clinical lead on one or more Phase 1-Phase 3 studies.
  • 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 safety and clinical operations teams.
  • Provides consulting for clinical perspective for various internal functions such as Commercial, Medical Affairs, Business Development, Pre-Clinical/Translational Science.
  • Interfaces and leads interactions with investigators, academicians, and thought leaders via a variety of interaction settings including academic society meetings, advisory boards, and investigator meetings.
  • 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 teams.
  • Works on regulatory submission documents including those for BLAs or CMAs.
  • Establishes and implements exploratory pharmacodynamic, predictive and prognostic biomarker plans in conjunction with pre-clinical scientists, consultants and collaborators.
  • Attends scientific meetings pertinent to clinical science activities
  • Maintains clinical and scientific awareness in area of expertise
  • Ensures adherence to Atara Bio’s Standard Operating Procedures and values, maintains the highest level of ethical behavior, leads by example
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Qualifications

Professional Qualifications

  • Minimum of an M.D., Ph.D., or PharmD., and advanced training in hematology, oncology, or immunology, with immunotherapeutic or similar experience preferred. Board certification is preferred.
  • Minimum 3 years of industry experience designing, leading and managing clinical studies in solid tumors, hematologic malignancies and preferably immuno-oncology.
  • Significant experience in designing and executing clinical studies. Participation in closing a clinical study and authorship of elements of a clinical study report in industry preferred. CMA/NDA/BLA experience a plus.
  • Demonstrated understanding of the drug development process evidenced by the ability to execute and deploy drug development strategic plans, to develop contingency plans, to provide technical and strategic advice, and to meet milestones and budgets.
  • Strong 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 as well as work effectively leading and participating in teams.
  • Experience working effectively in a fast-paced, team-based environment.
  • Strong clinical/scientific/technical skills.
  • Strong interpersonal capabilities and leadership skills.
  • Possesses a strong sense of urgency; proactively identifies challenges and problems and rapidly proposes solutions.
  • 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.
  • Skilled at motivating team members within Atara and partners and collaborators externally; fosters and nurtures teamwork.
  • Project management skills and focus on delivery of results.
  • Role model for Atara Bio’s values.

More about Atara Bio

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.

 

We’re proud of our team of 350+ 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.

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.”

 

Visit www.atarabio.com 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.
 
 

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