Work Location: Billerica, Massachusetts Shift: Department: HC-RD-BCB Biomarker Prog. Leads N&I Recruiter: Sarah Ellis
This information is for internals only. Please do not share outside of the organization.
Your Role
The Clinical Biomarker Lead is a key role within our organization, accountable for delivering fit-for-purpose clinical biomarker strategies to support dose finding, demonstrate mechanism of action, and enable patient stratification in our programs throughout the development lifecycle.
As an Associate Director Clinical Biomarker Lead Neurology & Immunology (N&I), you will lead a cross-functional biomarker team of subject matter experts to collaboratively develop and execute the clinical biomarker strategy in alignment with the clinical development plan according to agreed timelines & budget. You serve as the biomarker point of contact for clinical studies, represent the program biomarker team to management/governance, and support biomarker-relevant aspects of global regulatory interactions and filings. Building on your expertise, you also support the evaluation of opportunities for collaboration, licensing, and acquisition to further enrich the N&I pipeline.
Location: US/Billerica or Germany/Darmstadt
Who You Are
Minimum Qualifications:
B.S. with 8+ years professional experience, M.D. with 5+ years or PhD 3+ years. Degree in Life Sciences or equivalent.
Experience in clinical biomarkers and/or translational research within the pharmaceutical or biotech industry.
Preferred Qualifications:
Direct contribution to biomarker-driven clinical development
Strong scientific background (publication track record) in translational sciences; proven expertise in the fields of neurological, autoimmune, and inflammatory diseases is a plus
In-depth understanding of biomarker technologies
Strong understanding of clinical drug development strategies and quality related requirements under GxP
Understanding of the operational considerations for executing biomarker strategies in clinical development
Personal track record in a matrix leadership role
Strong presentation, communication, interpersonal, and stakeholder management skills
Ability to work effectively in multidisciplinary drug development teams by fostering scientific excellence, collaboration, data-driven decision-making, and a winning team culture
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