Global Biomarker Lead

Job not on LinkedIn

🔥 12 hours ago

🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

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Amgen

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1980

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

💰 $28.5G Post-IPO Debt on 2022-12

Healthcare • Biotechnology • Pharmaceuticals

Amgen is a global leader in biotechnology, focusing on the development and commercialization of innovative medicines made from living cells. The company aims to treat serious illnesses, often targeting diseases with limited therapeutic options. Amgen emphasizes scientific innovation and is committed to ethical research, patient safety, and environmental sustainability. It actively engages in clinical trials and is known for its contributions to the fields of cancer treatment and obesity management among others.

📋 Description

• Develop and drive clinical biomarker strategies, implementation, and execution for one or more programs • Develop clear and testable hypotheses for patient stratification/selection, pharmacodynamics, mechanism of action, and resistance evidence from clinical trial samples • Own biomarker elements in clinical protocols, biomarker analysis plans, regulatory submissions, investigator meetings, advisory boards, and publications • Build relationships with team members, key opinion leaders, academic institutions, and external partners • Integrate aligned and prioritized clinical biomarker evidence plans addressing clinical objectives and translational research • Partner with cross-functional stakeholders to drive biomarker innovation at product, disease, and modality levels • Interpret and communicate key clinical biomarker findings and next steps to cross-functional teams, Precision Medicine teams, and leadership

🎯 Requirements

• Doctorate degree and 3 years of industry experience in oncology clinical biomarker experience OR Master’s degree and 5 years of industry experience in oncology clinical biomarker experience OR Bachelor’s degree and 7 years of industry experience in oncology clinical biomarker experience OR Associate’s degree and 12 years of industry experience in oncology clinical biomarker experience OR High school diploma / GED and 14 years of industry experience in oncology clinical biomarker experience • Experience developing and executing pharmacodynamic, predictive, and exploratory biomarker strategies using clinical trial samples • Experience assessing and implementing biomarker platforms and technologies for oncology clinical programs • Proficiency interpreting and contextualizing biomarker data and communicating findings to diverse stakeholders • Clinical development experience working with cross-functional teams conducting clinical trials • Experience establishing and implementing biomarker collaborations with academic laboratories/KOLs and CROs • Proficiency in biomarker assay development and qualification, clinical sample analysis, and leading assay outsourcing processes • Experience working effectively and leading in a team environment • Strong written skills, including drafting technical reports, clinical protocols, clinical study reports, submission document responses, and biomarker publications • Strong communication skills when presenting strategy, plans, and results to leadership • Proficiency developing and executing biomarker strategies for immuno-oncology agents and/or ADCs

🏖️ Benefits

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions • Group medical, dental and vision coverage • Life and disability insurance • Flexible spending accounts • A discretionary annual bonus program • Stock-based long-term incentives • Award-winning time-off plans • Flexible work models where possible • Career development opportunities • Financial plans with opportunities to save towards retirement or other goals • Work/life balance support

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