Atara Biotherapeutics: Director, Preclinical Sciences
6 days ago
Atara Biotherapeutics: Director, Preclinical Sciences
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, Preclinical Sciences, will be instrumental in supporting the growth of Atara Biotherapeutics abilities in the areas of hematology, oncology, diabetes, metabolism, and muscle regulation. The incumbent will have hands-on responsibility designing preclinical pharmacology, pharmacokinetic, and toxicology IND enabling studies, 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 preclinical drug development.
Reports to: Chief Medical Officer
Location: Thousand Oaks, CA preferred, South San Francisco, CA potential.
Responsibilities:
- Design and optimizes pre-clinical studies and ensures these align with and support the clinical development plan.
- Leads a pre-clinical team, including interactions with internal and external collaborators.
- Writes pre-clinical protocols in collaboration with staff physicians, consultants and collaborators
- Conducts scientific review and interpretation of efficacy, pharmacokinetic, biomarker and toxicology data from preclinical studies.
- Has responsibility for the quality, coordination, scientific accuracy and timeliness of preclinical studies in collaboration with medical writing staff.
- Assists to oversee quality, coordination and timeliness of preclinical sections of INDs, Investigator Brochures, Meeting Abstracts and manuscripts.
- Presents and discusses data and findings at relevant team, KOL and regulatory meetings.
- Establishes and maintains strong working relationships with study investigators, KOLs, 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.S. or Ph.D degree and advanced training in biochemistry, cell biology, veterinary sciences, toxicology, hematology, immunology, oncology, endocrinology or internal medicine.
- Minimum 5 years of industry experience designing, leading and managing preclinical studies in therapeutic areas of immunology, endocrinology, hematology and/or oncology.
- Demonstrated understanding of the drug development process.
- Knowledge of Good Laboratory Practices (GLP), FDA regulations and guidelines, and applicable regulatory requirements.
- Experience in working with the design of clinical trial strategies to obtain regulatory approval.
- Ability to provide scientific expertise to a clinical development program and evaluate predictive and/or prognostic biomarker strategies for a product.
- Ability to effectively evaluate outside expert advice.
- The ideal candidate will be familiar with biomarker development and qualification for use as a companion diagnostic.
- Ability to run work independently.
- Experience working effectively in a very fast paced, collegial non-siloed team-based environment.
- Strong scientific/technical skills
- Strong interpersonal capabilities and ability to build and maintain networks
- 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.
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