Senior Director-Next Generation CAR-T (off-the-shelf), Clinical R&D
We are looking for a board-certified medical oncologist/hematologist with immunotherapy experience to provide medical and scientific leadership to our engineered T cell programs.
Atara is building engineered CAR T cells that target Acute Myelogenous Leukemia, B cell malignancies, Hepatocellular Carcinoma and additional Solid Tumors taking advantage of our experience with off-the-shelf viral T cells to revolutionize access and speed to treatment for patients.
Novel CAR signaling domains derived from scientific collaborations will be integrated from pre-eminent academic institutions that promise to improve T cell persistence and potency. In addition, our solid tumor targeting CARs incorporate checkpoint inhibition to overcome the immunosuppressive tumor cell microenvironment.
The Senior director will be responsible for designing and monitoring clinical trials to evaluate the efficacy, safety, kinetics of T cell expansion, and biomarker program for CAR T product candidates working together with internal and external regulatory colleagues. He/she will manage clinical and scientific collaborations with academic pioneers and consultants, will participate in regulatory interactions to support IND submission and clinical development in a fast-paced environment, and will gain experience in business development and product assessment.
The Sr. Director must be a strong leader with an excellent immunotherapy scientific knowledge base to operationalize the translation CAR T programs.
Reports to: EVP, Chief Scientific Officer
Location: Thousand Oaks or Westlake Village, CA.
- Designs and optimizes immuno-oncology CAR T clinical trials, including literature review, development of clinical protocols and amendments, investigator brochures, annual reports, abstracts, manuscripts and clinical study reports in collaboration with the cross functional team and academic collaborators.
- Identifies obstacles and implements solutions to avoid delays in clinical trial implementation.
- Serves as a medical monitor, including evaluation of the safety, pharmacology and efficacy in ongoing and completed studies and advocates for the health and well-being of patients.
- 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 IND, EOP2, BTD, BLA and equivalent international submission documents.
- Establishes and implements exploratory pharmacodynamic, predictive and prognostic biomarker plans in conjunction with staff, consultants and collaborators.
- Aids the Chief Scientific Officer in business development and product assessment including literature review and supervision of consultants.
- Ensures adherence to Atara Bio’s Standard Operating Procedures.
Travel- Travel is required (up to 25%).
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.
- Minimum of an M.D. or M.D./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.