Skip to main content

Associate Director, Translational Biomarker Strategies, Regulatory Affairs and Drug Development Solutions

Apply now
Primary Location: Reading, Berkshire, United Kingdom Additonal Locations: Aarhus, Denmark,DNK; Amsterdam, Netherlands,NLD; Antwerp, Belgium,BEL; Athens, Greece,GRC; Barcelona, Spain,ESP; Belgrade, Serbia,SRB; Bratislava, Slovakia,SVK; Bucharest, Romania,ROU; Budapest, Hungary,HUN; Dublin, Ireland,IRL; Espoo, Finland,FIN; Frankfurt, Germany,DEU; Kaunas, Lithuania,LTU; Ljubljana, Slovenia,SVN; Milan, Italy,ITA; Oeiras, Portugal,PRT; Oslo, Norway,NOR; Paris, France,FRA; Prague, Czech Republic,CZE; Riga, Latvia,LVA; Sofia, Bulgaria,BGR; Solna, Sweden,SWE; Tartu, Estonia,EST; Vienna, Austria,AUT; Warsaw, Poland,POL; Zagreb, Croatia,HRV Full time R1338792

Job description

IQVIA is changing an entire industry through inspired innovation. Our People make the difference. We believe that great ideas can come from anywhere. Great products come from great ideas. And great ideas come from great people. We look for the very best people and then give them meaningful work to do. Join IQVIA and help us make the world a better place.

PURPOSE 

Provide biomarker strategic support within the Regulatory Affairs and Drug Delivery Solutions (RADDS) department.  

Prepares separate or integrated biomarker plans and translational research strategies for clinical trial planning and marketing authorization activities for external clients as a part of a RADDS project team.

Support CDx development activities including high level evaluation of relevant client considerations and interactions with central lab or additional external laboratory.

RESPONSIBILITIES

Lead develop of strategies for clinical biomarker objectives and endpoints and testing in drug studies, indication prioritization, patient stratification, combination therapies, and drug candidate differentiation

• Identify pharmacodynamic and predictive biomarkers and assays for utility in the clinical setting; help define PK/PD/dose determination strategies

• Develop clinical biomarker testing strategies for clinical trials in collaboration with clinical team and central laboratory

• Advise clients on all aspects of CDx development together with central lab, and consulting and regulatory groups

• Author and review the translational sections of regulatory documents

• Manage internal and external collaborators to advance scientific and technical capabilities to design and execute translational research and precision medicine across all therapeutic areas. 

Additional responsibilities as needed and directed

• Acts as a preclinical pharmacology subject matter expert on regulatory document preparation or review.

• Competently writes regulatory and/or technical documents with minimal review by senior staff.

• Establishes relationships with many customers; may meet face to face without rest of team to discuss technical/clinical/scientific issues and present lessons learned. Adopts a proactive and flexible approach to resolve any issues.

• Present to clients at business development meetings by phone or in person, for a range of strategic and planning deliverables, at discretion of senior management

• Will be involved in biomarker and CDx thought leadership activities within and external to IQVIA in areas related to clinical research, genomics and precision medicine

• Performs other tasks or assignments, as delegated by RADDS senior management. 

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

•  Demonstrates comprehensive scientific and technical expertise related to biomarker strategies for clinical drug development

• Knowledge of companion diagnostics and familiarity with diagnostics development

• Good negotiating skills and the ability to identify and resolve issues, using flexible adaptable approach

•Strong software and computer skills, including MS Office applications

• Ability to work on several projects, retaining quality and timelines and can prioritize workload with minimal supervision • 

MINIMUM REQUIRED EDUCATION AND EXPERIENCE

• Advanced degree in life science-related discipline or professional equivalent plus at least 10+ years relevant experience* in drug development, trial planning and design and laboratory testing (*or combination of education, training and experience).  

#LI-ElenaSzudorova

#LI-Remote

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com

Apply now

Join our Global Talent Network

Let’s stay connected. Join our Global Talent Network to receive alerts when new opportunities become available that match your career ambitions.

Join our network
Top of page