This role supports the growth of Atara Bio's pipeline in autoimmune disease and immunotherapy 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 regulatory 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, CA (Hybrid/Flex) or Remote (West coast hours)
Travel: Travel may be required (up to 25%)
Primary Responsibilities
- Serves as the clinical lead on one or more early development studies.
- Designs and optimizes 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 INDs.
- 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.
- Ensures adherence to Atara Bio’s Standard Operating Procedures and values, maintains the highest level of ethical behavior, leads by example.
- Maintains clinical and scientific awareness in area of expertise.
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: Senior Medical Director, Clinical Sciences
Location: Thousand Oaks, CA (Hybrid/Flex) or Remote (West coast hours)
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
- Role model for Atara TRAIT values (Transparency, Respect, Accountability, Integrity, Trust)
