Global Biomarker Lead, Rare Disease

atAmgenRemoteUS flagUnited StatesFull-timeUncategorizedSenior$166.5k – $225.3k/year

Posted Jul 8

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee the creation and implementation of comprehensive, program-specific clinical biomarker strategies aimed at informing target engagement, pharmacodynamics, mechanism of action, and patient selection throughout both early and late-stage programs.

• Act as a precision medicine expert within product evidence generation teams to provide precision and translational medicine strategies that align with and deliver high-quality biomarker datasets.

• Accountable for the biomarker components in clinical protocols, biomarker analysis plans, regulatory submissions, investigator meetings, advisory boards, and publications.

• Collaborate with biomarker technical sub-teams to strategize all facets of clinical biomarker strategy execution, including specialty vendor assessments, biomarker budget and contract planning, biomarker and pharmacodynamic sample operations, biomarker data analysis plans, and cross-functional data sharing.

• Analyze and convey essential clinical biomarker insights effectively to cross-functional and non-technical stakeholders, such as Precision Medicine teams, product teams, R&D leadership, external scientific conferences, and general audiences.

• Design and implement biomarker studies and partnerships with academic laboratories and key opinion leaders (KOLs).


⛳️ Requirements

• Doctorate degree in a bioscience or medical field with 3+ years of industry experience.

• Alternatively, a Master’s degree in a bioscience or medical discipline with 6+ years of industry experience.

• Or a Bachelor’s degree in a bioscience or medical discipline with 8+ years of industry experience.

• PhD in a relevant discipline; PharmD, MD, or equivalent qualifications are also considered.

• At least 5+ years of pertinent experience, preferably within the industry.

• Strong expertise in rare diseases, autoimmunity, inflammation, cell biology, and genomics.

• Excellent written and verbal communication skills with a track record of drafting technical reports, clinical documents, and biomarker publications.

• Experience in deploying a diverse range of biomarker platforms and technologies, including biomarker assay development and validation.

• Proven ability to manage both direct and indirect reports, along with matrix management of staff through effective team leadership.

• Experience working in a globally distributed team environment with cross-cultural partnerships.

• Familiarity with global programs and regulatory submissions (IND/CTA/NDAs) is advantageous.


🏝️ Benefits

• A comprehensive employee benefits package, which includes a Retirement and Savings Plan with substantial 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 feasible.

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