Boehringer Ingelheim SR Translational Med & Biomarker Expert - Cancer Immunology in RIDGEFIELD, Connecticut
Boehringer Ingelheim is an equal opportunity global employer who takes pride in maintaining a diverse and inclusive culture. We embrace diversity of perspectives and strive for an inclusive environment which benefits our employees, patients and communities.
Through integrative leadership
provide clinical development and biomarker strategies to achieve Proof ofClinical Principle (PoCP) as a member of the Early Clinical Development (ECD) Team
drive and support translational 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 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 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.
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 Cancer Immunology and relevant technologies with strong scientific knowledge of the pathophysiology and respective therapies
Profound experience in Cancer 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
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
Boehringer Ingelheim is one of the world’s top 20 pharmaceutical companies and operates globally with approximately 50,000 employees. Since our founding in 1885, the company has remained family-owned and today we are committed to creating value through innovation in three business areas including human pharmaceuticals, animal health and biopharmaceutical contract manufacturing. Since we are privately held, we have the ability to take an innovative, long-term view. Our focus is on scientific discoveries and the introduction of truly novel medicines that improve lives and provide valuable services and support to patients and their families. Employees are challenged to take initiative and achieve outstanding results. Ultimately, our culture and drive allows us to maintain one of the highest levels of excellence in our industry. We are also deeply committed to our communities and our employees create and engage in programs that strengthen the neighbourhoods where we live and work. Boehringer Ingelheim, including Boehringer Ingelheim Pharmaceuticals, Inc., Boehringer Ingelheim USA, Boehringer Ingelheim Animal Health USA, Inc., Merial Barceloneta, LLC and Boehringer Ingelheim Fremont, Inc. is an equal opportunity and affirmative action employer committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender identity or expression; affectional or sexual orientation; disability; veteran or military status, including protected veteran status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
Boehringer Ingelheim is firmly committed to ensuring a safe, healthy, productive and efficient work environment for our employees, partners and customers. As part of that commitment, Boehringer Ingelheim conducts pre-employment verifications and drug screenings.
Organization: US-BI Pharma/BI USA
Title: SR Translational Med & Biomarker Expert - Cancer Immunology
Location: Americas-United States-CT-Ridgefield
Requisition ID: 189254