Senior/Principal Clinical Biomarker Lead - Hybrid

Hiring By - Biostaffic

 BioPharma

Job Highlights

Not Disclosed

Director

Posted 4 months ago
Job details
Description
This position is considered site based with flexibility for remote working. Working onsite a minimum of 2-3 days per week is required. Remote working norms will be clarified during the interview process.
As a role model for integrative leadership, the Principal Clinical Biomarker Lead acts as primary internal reference for translational and biomarker approaches in certain disease areas. As such, the Principal Clinical Biomarker Lead elaborates on biomarker strategies for clinical development and its appropriate representation in relevant documents and meetings/committees. Furthermore, the Principal Clinical Biomarker Lead initiates and leads exploratory non-interventional human studies, and supports the discovery, translation, clinical fit-for-purpose validation, implementation, evaluation and reporting of clinical biomarkers.
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 with internal 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 Inflammation 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.
Requirements
Senior Clinical Biomarker Lead
  • MD/PhD (in Biology, Biochemistry or Pharmacology) with strong practical experience in independent clinical/research activities
  • At least 3 years of experience in a pharmaceutical company's drug development environment or independent clinical research activities in academia preferred.
  • Biomarker experience in Inflammatory diseases strongly preferred
  • Experience relevant technologies with strong scientific knowledge of the pathophysiology and respective therapies
Principal Clinical Biomarker Lead
  • MD or PhD (in Biology, Biochemistry or Pharmacology) from an accredited institution with strong practical experience in independent clinical/research activities.
  • At least six (6) years of experience in a pharmaceutical company´s drug development environment or independent clinical research activities in academia preferred.
  • Biomarker experience in Inflammatory diseases strongly preferred
  • Experience in relevant technologies with strong scientific knowledge of the pathophysiology and respective therapies.
  • Profound experience in certain therapeutic area.
  • 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.
  • Comprehensive knowledge in clinical drug development and biomarker analytics.
  • Ability to communicate effectively and in an integrative manner with internal and external experts and with opinion leaders.
  • Basic project management skills.
Compensation Data
This position, Senior Clnical Biomarker Lead offers a base salary typically between $135,000 and $232,000.  The position may be eligible for a role specific variable or performance based bonus and or other compensation elements. For an overview of our benefits please click here.

Benefits Offered?

  • No

Bonus Offered?

  • No

Travel Required?

  • No

Location:

Experience:

  • Director

Global Experience Needed?

  • No

Specialized Experience Needed?

  • No

Apply before:

  • Apr 16, 2024
Company Overview
Boehringer Ingelheim
Boehringer Ingelheim

Current Openings: 0

Seit mehr als 135 Jahren erforscht, entwickelt und produziert Boehringer Ingelheim neue Medikamente mit hohem therapeutischem Nutzen für Mensch und Tier. Als Pharmaunternehmen in Familienbesitz planen wir langfristig und investieren daher besonders in die Forschung und Entwicklung. Wir sind stolz, so einige der größten Gesundheitsprobleme unserer Zeit angehen zu können. Unsere Vision „Werte schaffen durch Innovation“ hat unsere Zusammenarbeit seit jeher geprägt und ist für uns Anspruch und Antrieb zugleich. Mit Hauptsitz in Ingelheim, Deutschland, beschäftigt Boehringer Ingelheim weltweit insgesamt rund 53.000 Mitarbeiter. Weitere Informationen zu Boehringer Ingelheim finden Sie unter www.boehringer-ingelheim.de
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