Clinical Scientist – Clinical Development & Protocol Design (Phases III/IV)

Avant Health
We are a clinical research organization (CRO) and a strategy consulting firm that specializes in designing and implementing clinical and observational research across North America, Europe and other parts of the world. We identify, create and communicate value of healthcare and pharmaceutical products and services, solidifying the roadmap to commercial success, while maintaining focus on patient-centricity.
Position Overview
We are seeking a highly collaborative, metrics-driven Clinical Scientist to join our growing team and serve as the scientific architect for our late-stage international Clinical Trials. In this pivotal role, you will lead the end-to-end scientific design and author the core clinical protocols for complex Phase III and Phase IV (post-marketing) studies.
Our portfolio spans high-impact therapeutic sectors: Dermatology, Oncology, Immunology, and Rare Diseases. The ideal candidate bridges the gap between high-level medical strategy and execution. You must be a master protocol writer with a deep conceptual grasp of biostatistics to collaborate closely with our statistical teams, alongside a practical understanding of clinical operations to ensure protocols are logistically feasible for global trial sites and vulnerable patient populations.
Key Responsibilities
Late-Stage Protocol Authoring: Lead the development and writing of high-quality Phase III/IV trial protocols, major amendments, Case Report Forms, and informed consent documents.
Therapeutic Architecture: Apply scientific expertise across multi-indication pipelines—specifically managing the unique nuances of oncology endpoints, immunology pathways, dermatological scoring indexes, and rare disease small-population constraints.
Cross-Functional Translation: Act as the primary scientific bridge between multiple research functions and lead trial designs and ensure they are scientifically rigorous, mathematically sound, and operationally viable.
Statistical Collaboration: Apply a strong understanding of late-stage biostatistical concepts (e.g., survival analysis, non-inferiority designs, power analysis, and endpoint validation structures) to collaborate directly on the Statistical Analysis Plan (SAP).
Operational Feasibility: Review trial designs through an operational lens to ensure protocols minimize site burden, maximize patient retention, and scale effectively across global, multi-center late-phase frameworks.
Regulatory & Data Synthesis: Synthesize complex data to support major global regulatory submissions (FDA, EMA, health authorities) and contribute directly to the writing of comprehensive Clinical Study Reports.
Required Qualifications & Skills
Education: Advanced scientific degree required (Ph.D., Pharm.D., M.D., or Master’s in Life Sciences/Public Health with equivalent extensive experience).
Experience: 5+ years of direct experience in clinical research within a CRO setting, with a proven track record of authoring (hands-on) successful Phase III or IV trial protocols.
Therapeutic Footprint: Demonstrated experience working in at least one (ideally multiple) of our core areas: Dermatology, Oncology, Immunology, or Rare Diseases.
Statistical Literacy: Strong conceptual foundation in biostatistics. Direct hands-on programming experience in statistical software like SAS or R is optional but highly valued; the ability to interpret, critique, and direct statistical strategy is required.
Operational Awareness: Deep understanding of Good Clinical Practice (GCP), ICH guidelines, global regulatory pathways, and the practicalities of large-scale international site management.
Geographic Flexibility: Must be based in the US and capable of working autonomously in a remote, cross-border team environment. Individuals located in Europe may be considered.
If you are interested in exploring this opportunity with Avant Health, please submit your CV and a cover letter (including a comment on salary expectations) to Info@Avant-Health.com.

Work arrangement
Yes