Translational Science Lead
Gaithersburg, MD - USA
Job Summary
The Translational Science and Early Clinical Development (TSECD) department delivers seamless end-to-end translational evidence for our Respiratory & Immunology (R&I) portfolio: robust human target validation development and execution of early clinical development plans with clear evidence of target engagement and pharmacology and deeper understanding of the mechanism of action for programs in clinical development via biomarker-driven insights.
The Translational Science Lead (TSL) is a key role within TSECD accountable for the development and execution of the translational strategies for portfolio projects underpinned by a deep understanding of disease relevant pathways and drivers. This includes human target validation plans at the time of target selection strategies for target engagement and delivering evidence for proof-of-mechanism (PoM) in early clinical trials and deepening our understanding of the mechanism of action and patient selection during clinical development.
The Translational Science Lead is a project facing role collaborating closely with biosciences during preclinical development to support human target validation packages and leading biomarker data exploration in non-interventional cohorts and via back-translated clinical trials. As the program moves into the clinic the TSL contributes significantly to clinical development including but not limited to application of target engagement assays developing and executing an appropriate biomarker sampling strategy and enabling the evaluation of key novel biomarkers by facilitating assay transfer and execution in the clinical trial setting. As a program progresses in clinical development TSLs are the key scientific voice on project teams enabling product development and launch through generation of the mechanistic differentiation and scientific evidence package for our assets and providing robust scientific reasons to believe for lifecycle opportunities.
Accountabilities and responsibilities:
Develop and integrate translational science strategies for R&I projects and clinical studies including accountability for human target validation target engagement and precision medicine.
Build mechanistic understanding of the target and disease through designing and leading innovative application of experimental methods and technologies.
Establish the translational evidence package for new targets utilizing public and proprietary biobanks to better to understand responding sub populations biomarkers and the biology of our drug targets.
Integrate and interpret clinical biomarker and multi-omics data to generate mechanistic and translational insights that enhance patient outcomes.
Partnering with data science to enable AI/ML strategies to discover mechanisms biomarkers and patient phenotypes.
Identifying and enabling PoM biomarkers to demonstrate target engagement at FirstTimeInHuman clinical trials.
Delivering precision medicine strategies to identify the patients most likely to benefit from our medicines including early molecular biomarker assay development planning if common clinical features are not sufficient for precision medicine.
Represent TSECDs translational strategy through investment decisions and governance interactions and facilitate cross-functional communication to enable accurate execution.
Integrate translational strategy into key clinical documents.
Clinical Study Protocols Informed Consent Forms Sample Life Cycle Plans Case Report Forms local Health Authority applications Human Genetic Resources Clinical Study Reports.
Contribute to regulatory and health authority responses author Submission document sections relating to Mode of Action PK/PD precision medicine.
Prepare and review scientific publications to support publication and marketing strategies.
Minimum Requirements Education and Experience:
PhD or MD equivalent with a strong experimental drive and background in relevant scientific field
Post-doc experience or otherwise relevant scientific research experience
Minimum 5 years of experience in a Biomedical or Pharmaceutical role
Experience in an academic and/or industry setting
Strong publication record
Desirable Skills/Experience:
8 years of experience in a Scientific role within the Biomedical or Pharmaceutical Industry
Experience leading projects
Experience from clinical trials
Experience and skills
Proven ability to deliver translational readouts and human target validation and their application to drug discovery.
Excellent understanding of the Respiratory therapy area including but not limited to COPD Asthma NCFBE and IPF/ILDs and disease biology including related molecular pathways and mechanisms.
Experience and knowledge of the biological basis for target engagement biomarkers and familiar with PoM biomarker invention and implementation.
Experience and knowledge of the biological basis for patient stratification and precision medicine and familiar with patient selection biomarker invention and implementation.
Broad understanding of relevant technologies and methodologies along with excellent scientific skills and ability to design experiments to address key scientific questions.
Excellent skills in hypothesis forming and testing and able to draw conclusions and suggest next steps based on the experimental data.
Shown experience and solid understanding of pharmacology translational medicine and clinical sciences as well as clinical development with pre-eminence in at least one of these areas.
Demonstrated leadership skills ability to be a self-starter.
Strong team working skills with a proven track record of working collaboratively to ensure scientific excellence and robust delivery to projects.
Excellent written oral presentation and interpersonal skills.
Are you interested in working at AZ apply today!
When we put unexpected teams in the same room we unleash bold thinking with the power to inspire life-changing -person working gives us the platform we need to connect work at pace and challenge perceptions. Thats why we work on average a minimum of three days per week from the office. But that doesnt mean were not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.
The annual base pay for this position ranges from $175498.40 - $263247.60 USD Annual. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors including market location job-related knowledge skills and addition our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles) to receive a retirement contribution (hourly roles) and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program 401(k) plan; paid vacation and holidays; paid leaves; and health benefits including medical prescription drug dental and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired employee will be in an at-will position and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time including for reasons related to individual performance Company or individual department/team performance and market factors.
At AstraZeneca we champion a perspective of excellence. Our environment is driven by a belief that good can always be better. We continuously seek opportunities to contribute by harnessing science and evidence to foresee risks. Its a place where innovation thrives as we find new ways to improve outcomes for patients. With a focus on growth and innovation there are always exciting products to quality assure as we go to market globally.
Ready to make a difference Apply now to join our team!
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Date Posted
23-Apr-2026Closing Date
07-May-2026Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and furtherance of that mission we welcome and consider applications from all qualified candidates regardless of their protected characteristics. If you have a disability or special need that requires accommodation please complete the corresponding section in the application form.
About Company
AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, ... View more