Global Biomarker Lead, Rare Disease

🕒 July 7

🇺🇸 United States – Remote

💵 $166.5k - $225.3k / year

⏰ 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

• Lead the development and execution of robust program-specific clinical biomarker strategies to inform target engagement, pharmacodynamics, mechanism of action, and patient selection across early and late stage programs • Serve as precision medicine subject matter expert within product evidence generation teams to deliver precision medicine and translational medicine approaches to enable strategic alignment and delivery of high-quality biomarker datasets • Responsible for biomarker elements in clinical protocols, biomarker analysis plans, regulatory submissions, investigator meetings, advisory boards and publications • Lead and partner with biomarker technical sub-teams to plan all components of clinical biomarker strategy implementation including specialty vendor evaluations, biomarker budget and contract planning, biomarker and pharmacodynamic sample operations, biomarker data analysis plans, and cross-functional data sharing. • Interpret and communicate key clinical biomarker findings in an impactful way to cross functional and non-technical stakeholders, including Precision Medicine teams, product teams, R&D leadership, external scientific congresses, and lay audiences. • Establish and implement biomarker studies and collaborations with academic laboratories/KOLs

🎯 Requirements

• Doctorate degree in a bioscience or medical discipline and 3+ years of industry experience • Or Master’s degree in a bioscience or medical discipline and 6+ years of industry experience • Or Bachelor’s degree in a bioscience or medical discipline and 8+ years of industry experience • PhD in a relevant field; PharmD, MD, or equivalent considered. • Minimum 5+ years of relevant experience, ideally in industry • Strong expertise in rare disease, autoimmunity, inflammation, cell biology, and genomics • Strong written and verbal communication skills with experience drafting technical reports, clinical documents, and biomarker publications, • Experience implementing a broad array of biomarker platforms and technologies including biomarker assay development and qualification • Experience in managing direct and dotted line reports, as well as matrix management of staff through team leadership • Experience working effectively in a globally dispersed team environment with cross-cultural partners • Experience with global programs and regulatory filings (IND/CTA/NDAs) is a plus.

🏖️ 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, or for field sales representatives, a sales-based incentive plan • Stock-based long-term incentives • Award-winning time-off plans • Flexible work models where possible.