About the company
A career at the company offers opportunity, ownership and impact.
All over the world, the company colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. the company, a global leader in the biopharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.
The candidate will be accountable for leading our early clinical development teams in translating our drug discovery programs into competitive clinical development strategies. The candidate will combine a deep understanding of cancer mechanisms in cell autonomous mechanisms and the tumor microenvironment (e.g. immuno-oncology) with strong experience in clinical biospecimen analysis to design and execute clinical translational studies that inform drug development decisions and that drive bedside to bench learning.
The successful candidate will partner collaboratively across integrated, multi-functional program teams encompassing development and research, and will identify, prioritize, and evaluate predictive and pharmacodynamic biomarkers that provide Proof of Mechanism and early Signs of Efficacy that enable proof of concept studies in selected patient populations.
• Responsible for the development of scientifically rigorous clinical translational research strategies that assess Proof Mechanism, establish early Signs of Efficacy, illuminate mechanisms of resistance, and drive combinations.
• Identifies, prioritizes, and evaluates predictive and pharmacodynamic biomarkers that provide Proof of Mechanism and early Signs of Efficacy that enable proof of concept studies in selected patient populations by partnering collaboratively across integrated, multi-
functional clinical program teams encompassing development (e.g. clinical, clinical pharmacology, statistics, development operations) and research (e.g. close interactions with biology and computational scientists), clinical biomarker assay specialists, diagnostics and asset leaders.
• Analyzes, interprets and reports results of clinical biomarker analyses, including support of regulatory filings.
• Innovates with academic collaborators to expand clinical translational research.
• Leverages external contract research organizations and vendors to execute biomarker analyses.
• Accountable for the development of Laboratory Developed Tests that seamlessly transition into Companion Diagnostics as needed.
• Advanced degree (PhD, MD, MD/PhD, Pharm. D.), with focus on cancer biology and/or immunology and a minimum of 8 years of experience in Oncology drug discovery and development. Candidates should possess an advanced understanding of modern cancer biology, cancer genetics and immuno-oncology, with a documented focus on translational research in phase 1 and 2 clinical trials.
• Demonstrated excellence in designing, executing and interpreting studies of cancer biomarkers in clinical trials, including biomarker development, validation and clinical application.
• Able to drive effective interactions at the interface between lab bench-based research and early clinical development up to proof of concept studies.
• Significant external scientific influence within the academic community, publication of primary research results in high-quality, peer-reviewed journals and national/international scientific reputation.
• Builds connections by developing positive, collaborative partnerships that drive sustainable business results.
• Experience with clinical protocol design, clinical trial operations, clinical trial biospecimen logistics, analytical and clinical validation of biomarker assays, and vendor interactions.
• Experience leveraging genomic and molecular information from patients with extraordinary responses in early stage clinical trials to guide clinical development.
• Direct experience and/or familiarity with state-of-the-art technologies applicable to cancer biomarker and/or immune response analysis (such as next-generation sequencing, immunohistochemistry, immunofluorescence, flow cytometry, in situ hybridization, gene expression profiling, or digital image analysis).
• Demonstrated ability to think strategically and creatively while contributing to multiple projects.
• Thrives in a highly collaborative, multi-disciplinary team setting.
• Highly effective verbal and written communication skills.
• Experience with multiple modalities (e.g. small molecules, nanoparticles, antibodies, antibody-drug conjugates, bispecifics) preferred.
Other Information - Internal
Colleagues who are issued an Incident Final Warning (IFW) on or after January 1, 2016, are not eligible to post and compete for a position for a period of 12-months from the date an IFW is issued.
EEO & Employment Eligibility
the company is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. the company also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. the company is an E-Verify employer.
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