Jobs · Analyst · Indiana

Clinical Research Physician - GU Oncology

BioSpace · Indianapolis, IN · 3 wk ago
Analyst$198k–$389k/yrFull-time

Position Summary

The Clinical Research Physician (CRP), Clinical Development, provides scientific and clinical expertise to drive evidence generation and clinical strategy across Phase 1–3 programs. This role leads trial design and execution in close partnership with regulatory, statistics, NPP, medical affairs, and translational teams to deliver patient-focused outcomes.

Responsibilities

  • Lead design and authoring of Phase 1–3 protocols with cross-functional input

  • Ensure alignment of trial design (1°/2° endpoints, SOA, imaging, population, line of therapy, biomarker incorporation) with program goals across functional partners (regulatory, stats, NPP, medical affairs, CMC, translational)

  • Support scientific advisory boards and steering committee meetings

  • Design and execute enrollment plans including country and site selection, PI identification, and risk mitigation/trend monitoring

  • Partner with Medical Affairs and NPP to support TPP and indication deliverables

  • Proactively engage MSL teams for key insights and deliverables

  • Primary author for clinical content development for regulatory submissions and meetings

  • Author (with MW) disclosures

  • Define and monitor success metrics; ensure cross-functional alignment

  • Synthesize external data to inform trial design and strategy

  • Primary owner/author in data presentation at internal governance meetings; support external presentations

Qualifications

  • Medical Doctor or Doctor of Osteopathy. Must be board eligible or certified in relevant field or have completed the comparable level of post-medical school clinical training relevant to the country of hiring.

  • Physicians trained outside the US who are not US board eligible or certified may be hired directly for employment in the US at the discretion of the Chief Medical Officer.

  • Non-US trained physicians must have completed education and training at a medical school that meets the requirements of the Liaison Committee on Medical Education (LCME).

  • 3 years clinical and/or pharmaceutical industry experience

  • Clinical development experience

  • Experience supporting Phase I–III clinical programs

  • Oncology in particular GU oncology experience

  • Strong understanding of medical governance and regulatory requirements

  • Demonstrated ability to communicate complex scientific data to diverse audiences

  • Prominent cross-functional collaboration and stakeholder engagement skills

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