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SR Translational Med & Biomarker Expert Immunology

Description: Through integrative leadership provide clinical development and biomarker strategies to achieve Proof of    Clinical Principle (PoCP) as a member of the Early Clinical Development (ECD) Team drive and supporttranslational medicine and biomarker aspects in post-PoCP projects including drug registration and Product Maintenance & Optimization (PMO) activities Enable the discovery, translation, fit-for-purpose assay validation, analysis and clinical qualification of biomarkers. Ensure appropriate and timely evaluation, interpretation and reporting of clinical biomarker data including presentation at relevant meetings/committees As appropriate, initiate and lead exploratory non-interventional human studies, and assess novel biomarker methods and assays   As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees   Duties & Responsibilities: Be a role model for integrative leadership in all aspects of early clinical drug development Ensure regulatory compliance with ICH GCP (or alike) of biomarker analysis in clinical studies to provide credible and reliable data and reported results, and to protect the rights, safety, wellbeing, and confidentiality (data integrity, protection and data privacy) of trial subjects. As Trial Biomarker Analyst (TBMA), execute the agreed biomarker strategy in conjunction withinternal as well as external partners and interfaces. For BI-sponsored clinical trials, this includes operational aspects, e.g. the fit-for-purpose assay validation, implementation, monitoring, data transfer and reporting of biomarkers, as well as budgetary adherence. As Biomarker Integrator (BMI), represent BM functions in the ECD team thereby providing clinical development and biomarker strategies to achieve PoCP. Apply integrative leadership skills to coordinate a cross-functional team of experts to ensure timely development of biomarker strategies, contributions to respective documentation (e.g. Clinical Development Plan (CDP)) and presentation at relevant meetings/committees. As appropriate, support Companion Diagnostics (CDx) development. Adapt biomarker strategy based on novel study results. As a Core Team member represent TMCP and drive TMCP aspects through the ECD phase and ensure timely delivery. Provide relevant sections to the investigator's brochure (IB). Be accountable for all clinical operational aspects including budget oversight up to PoCP. Report to relevant governance bodies with respect to strategic & study content related aspects (CEC) as well as operational clinical & budget related aspects (DC). As a member of the disease area biomarker team, provide clinical biomarker strategy on a disease area level, generate an aligned and actionable disease area biomarker plan, as well as plan and conduct resulting  work-packages within strict timelines and in close collaboration with the relevant therapeutic area in Research and Medicine. Develop biospecimen banking strategies for a disease area. Initiate and lead exploratory non-interventional studies for biomarker identification and qualification. This includes generating a project proposal and plan with strict timelines, budget, and deliverables in close collaboration with the respective therapeutic area in Research and Medicine. Initiate and lead interactions with external experts and identify external collaborations on biomarker aspects. Act as a BI representative to medical experts, expert groups, consortia, and other scientific, medical or regulatory organizations. Provide biomarker relevant sections of drug registration dossiers in e.g. Summary of Clinical Pharmacology and Associated Methods, Summaries of Clinical Efficacy and Safety. Support drug registration by participation in regulatory authority meetings (e.g. pre-IND, pre-NDA). Provide input to responses to regulatory authority queries, as appropriate. Two positions available   Requirements: MD/PhD (in Biology, Biochemistry or Pharmacology) from an accredited institution required with strong practical experience in independent clinical/research activities At least five (5) years of experience in a pharmaceutical company's drug development environment or independent clinical research activities in academia preferred. Experience in Immunology and relevant technologies with strong scientific knowledge of the pathophysiology and respective therapies Profound experience in Immunology Comprehensive knowledge in clinical drug development and biomarker analytics Basic project management skills Profound knowledge of and experience in the preclinical and clinical application of biomarkers, their evaluation and analysis and the linkage to pathophysiology and clinical endpoints Ability to communicate effectively and in an integrative manner with internal and external experts and with opinion leaders   Eligibility Requirements: Must be legally authorized to work in the United States without restriction Must be willing to take a drug test and post-offer physical (if required) Must be 18 years of age or older  189260
Salary Range: NA
Minimum Qualification
Not Specified years

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