Head of Translational Sciences for Microbial Sciences
This position is located in Gaithersburg, MD. A relocation package may be available for non-local candidates.
At AstraZeneca, we are constantly pushing the boundaries of science to deliver life-changing medicines to patients, with a real passion for discovery and a pipeline to show for it. Here, you’ll have the opportunity to make a difference in people’s lives every single day.
We are seeking candidates with a Ph.D. or M.D./Ph.D. in microbiology/immunology or similar area with emphasis in translational medicine, biomarkers, immunology and drug or antibody development. Successful candidate will be part of Microbial Sciences tasked with unlocking the potential of the microbiome to discover and develop new drugs. The Head of Translational Sciences manages scientists that design and support observational studies, clinical trials and support development of novel therapeutics for the prevention or treatment of diseases in AstraZeneca’s core therapeutic areas of oncology, respiratory, inflammation, cardiovascular and metabolic diseases. An understanding of clinical trial design and regulatory processes, proof-of-concept studies, diagnostics, clinical immunology and biomarkers is required. The individual will help design, execute and analyze studies to support discovery of new targets, new drugs and support clinical development of new drugs to treat or prevent disease. Specifically, the individual will be involved in overseeing studies to identify new targets, new drugs, biomarkers, and developing in vitro, in vivo and ex vivo assays to support observational and clinical studies. The individual must have a strong background in immunology, drug development, assay development and validation, bioinformatics and GCP guidelines. Strong project planning skills, management skills and experience with IND-enabling studies and clinical trials are required. Previous industry experience with a record of effective project leadership and a good understanding of the drug development process, from lead identification through proof-of-concept clinical trials, is required. The successful candidate should be able to work productively in a matrix team environment, as well as take ownership of multiple projects. The individual will support programs within Microbial Sciences and will serve on product development teams. Excellent written, oral, presentation and interpersonal skills are required.
Specific duties and major responsibilities include:
- Serve on the Microbial Sciences leadership team and develop strategic and operational departmental plans.
- Collaborate with team leaders in the core therapeutic areas of Respiratory, Immunology, Autoimmunity, Oncology, Cardiovascular, Renal and Metabolism to develop, implement and analyze biomarkers from observational and clinical trials.
- Work effectively with microbiome discovery and targeted therapeutics to support drug discovery and development through IND.
- Develop new processes and procedures to collect and analyze microbiome-centric samples from clinical trials and observational studies
- Collaborate with research, toxicology and pharmacokinetics department to design animal studies to help select a primary indication and a first in human dose for clinical trials
- Work closely with Research, Clinical Development, Clinical Operations, Data Science and core Therapeutic Areas to design sample collection, sample testing algorithms and prepare a lab manual for a Phase 0, I and II clinical trials
- Manage and mentor staff in Microbial Sciences Translational Sciences
- Serve as representative on Product Development teams
- Prepare high quality presentations for both internal and external meetings
Education: PhD with at least 12 years ofexperience in research, immunology, biomarkers and drug and/or biologics development, including a minimum of 5 years of experience in the industry.
- Strong knowledge of immunology and drug development.
- Proven track record of industry experience in biomarker, translational and clinical research in immunology and drug or biologics development.
- Familiarity with predictive biomarkers, personalized healthcare approaches highly desired.
- Ability to handle human clinical samples and design and execute assays to identify biomarkers associated with elevated risk of infection.
- Hands-on experience in development of in vitro and in vivo assays for clinical and research use, with the aim of assessing biomarkers for indication selection.
- Ability to develop biomarker strategies and diagnostics to evaluate successful response to prophylaxis and/or treatment with monoclonal antibody.
- Knowledge of clinical protocols and regulatory processes.
- Organizational skills and demonstrated ability to write technical reports, monthly updates and biomarker protocols, perform quantitative analyses, and graph and present data.
- Outstanding verbal and written communication skills.
- Strong leadership and interpersonal skills to work in a matrix team environment.
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.