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Therapeutic Area Biomarker Lead (Renal) - Associate Director or Director

Novartis
Full-time
On-site
Cambridge, MA
$145,600 - $344,500 USD yearly
Clinical Research and Development

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Role Summary

Therapeutic Area Biomarker Lead (Renal) - Associate Director or Director. Lead areas related to renal diseases, overseeing project matrix teams of Biomarker Leads and subject matter experts to support clinical projects as the Biomarker Lead. Biomarkers enable translational research and precision medicine approaches across early and late clinical development, covering target engagement, pathway modulation, efficacy, PD/PK, safety, disease modification, patient selection, and other contexts of use to support program decisions.

Responsibilities

  • Act as BMDโ€šร„รดs strategic and scientific leader within the renal portfolio to develop fit-for-purpose clinical biomarker strategies and plans, translational sciences, data, and precision medicine approaches in collaboration with clinical development, research, and other translational medicine functions.
  • Identify, develop, and drive disease, mechanistic, and compound biology to support clinical and precisionmedicine approaches across the multi-indication portfolio; contextualize and interpret biomarker data.
  • Lead or co-lead enterprise-wide cross-functional teams around asset strategies, indication or pathway task forces, translational data, and precision medicine.
  • Lead a matrixed group of biomarker leads and subject matter experts to develop biomarker strategies across the Research-Development-Commercial continuum.
  • Act as Biomarker Lead on clinical projects to drive biomarker and precision medicine strategy at the compound level.
  • Represent BMD on decision boards and during clinical protocol reviews for their projects.
  • Develop deep understanding of translational biomarkers for a project, focusing on compound, disease, target, and pathway biology.
  • With data science leads, drive translational data efforts integrating large-scale patient multi-modal data sets (omics, imaging, digital, etc.).
  • Provide thought leadership with other BMD TABLs to identify alignments and drive innovation across assets, indications, and therapeutic areas.
  • Report to the Therapeutic Area Biomarker Head and collaborate to develop disease area/indication/project biomarker strategies and plans, implementation, contextualization, and interpretation.
  • Act as an enterprise partner and strategic leader in a matrix environment, integrating and representing projects in internal/external scientific discussions and initiatives.
  • Stay up to date on clinical, disease, biology and scientific literature for respective disease areas or indications.

Qualifications

  • This position will be located at the Cambridge, MA site and will not be remote; approximately 5% travel expected.
  • Minimum 3โ€šร„รฌ5 years (Associate Director level) and 10 years (Director level) of experience with deep understanding of renal biology, immunology, autoimmune diseases, genetic diseases, or related areas; strong translational research, drug development and clinical biomarkers experience.
  • PhD, MD, PharmD, MD/PhD, or equivalent degrees with relevant experience.
  • Pharmaceutical industry experience strongly preferred.
  • Scientific excellence evidenced by academic/industry career track and/or high-quality publications; clinical and/or biological expertise in renal biology, autoimmune disease, genetic diseases, or related areas.
  • Experience with quantitative research and data; familiarity with genetics and omics profiling, clinical imaging, machine learning, genetics or data science is strongly preferred.
  • Proven success in leading and partnering in multidisciplinary matrix teams across pharma, biotech, academia, or commercial functions.
  • Well-developed interpersonal and leadership skills with strong presence and ability to influence within large organizations.

Skills

  • Strategic biomarker leadership in renal/related indications
  • Translational science and biomarker strategy development
  • Cross-functional and matrix team leadership
  • Data integration and translational data analytics
  • Stakeholder management and communication

Education

  • PhD, MD, PharmD, MD/PhD, or equivalent

Additional Requirements

  • Travel: ~5% travel required (domestic and/or international).
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