Atara Biotherapeutics: Director, Clinical Research and Development (Immuno-Oncology – Hematolog[...]
Behavioral Health Market Context
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Qualifications
- •Minimum 2 years of industry experience designing, leading and managing clinical studies in solid tumors, hematologic malignancies and preferably immuno-oncology
- •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 immunologic and oncologic technical issues to clinical, regulatory, biomarker, biostatistics, data management and manufacturing colleagues who may have a non-medical background
- •Ability to run 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
- •12 more items(s)
Responsibilities
- •Atara Biotherapeutics: Director, Clinical Research and Development (Immuno-Oncology – Hematology/Oncology)
- •The Director, Clinical Research and Development, will be instrumental in supporting the growth of Atara Biotherapeutics pipeline in immuno-oncology and hematology-oncology
- •The incumbent will have hands-on responsibility designing clinical trials to evaluate the efficacy, safety, clinical pharmacology, and pharmacokinetics of biologic and cellular immunotherapies, and also managing scientific collaborations with pre-eminent academic institutions and consultants
- •The incumbent should have an interest and passion for work in all aspects of clinical drug development
- •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 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%)
- •Project management skills and focus on delivery of results
- •9 more items(s)
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