Translational Science Lead

AstraZeneca • Gaithersburg, MD

23h • Hybrid

About The Position

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.

Requirements

• 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
• 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.

Nice To Haves

• 8+ years of experience in a Scientific role within the Biomedical or Pharmaceutical Industry
• Experience leading projects
• Experience from clinical trials

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 First‑Time‑In‑Human 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 TSECD’s 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.

Benefits

• a qualified retirement program [401(k) plan]
• paid vacation and holidays
• paid leaves
• health benefits including medical, prescription drug, dental, and vision coverage
• short-term incentive bonus opportunity
• eligibility to participate in our equity-based long-term incentive program (salaried roles)

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree
• Number of Employees: 5,001-10,000 employees