Atara Biotherapeutics: Director, Clinical Research and Development (Immuno-Oncology - Hematolog[...] (South San Francisco)

Atara Biotherapeutics: Director, Clinical Research and Development (Immuno-Oncology – Hematology/Oncology)

Director, Clinical Research and Development (Immuno-Oncology – Hematology/Oncology)

Atara Biotherapeutics’ mission is to develop novel treatment options for patients with severe and life-threatening conditions that have been underserved by scientific innovation. We serve that mission by investigating biotech-derived therapies targeting unique pathways to halt or reverse patients’ underlying diseases.

Position Summary

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.

Reports to: Chief Medical Officer

Location: Thousand Oaks, CA preferred, South San Francisco, CA potential.

Responsibilities:

• 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%).

Professional Qualifications

• Minimum of an M.D. or M.D., Ph.D degree, 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.
• 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.
• Project management skills and focus on delivery of results.