Clinical Scientist Immunology
Job Summary
The Clinical Scientist will provide scientific, strategic, and operational leadership in early clinical development, focusing on peri IND and first-in-human programs. You will be responsible for advancing programs from translational insights through early-phase clinical studies while ensuring strong alignment between mechanisms, biomarkers, and clinical strategy. The role requires collaboration across functions to execute Phase 1/2 studies and maintain high standards of patient safety and data quality.
Responsibilities
- Design and execute early-phase (Ph1/2) clinical studies
- Integrate translational biomarkers into clinical strategy
- Support IND-enabling documentation and study protocols
- Collaborate cross-functionally with data, regulatory, and clinical teams
Required Skills
- Advanced degree (MD, PhD, PharmD)
- 6+ years in biotech/pharma clinical development
- Expertise in immunology and translational science
- Strong analytical and cross-functional leadership
Job Details
Responsibilities:
- Contribute to the design and execution of early-phase (Ph1/2, peri IND) studies, ensuring alignment with translational hypotheses and overall program strategy.
- Support development of clinical development plans, study protocols, and IND-enabling documents.
- Integrate mechanistic insights, biomarkers, and clinical endpoints to enable proof-of-concept and decision-making.
- Provide scientific input into early clinical study conduct, including protocol adherence and emerging data interpretation.
- Support evaluation of safety data and emerging signals in collaboration with cross-functional partners.
- Contribute to data review discussions and internal governance as appropriate.
- Support CRF design and data collection strategy to ensure fit-for-purpose capture aligned with study objectives.
- Partner with Data Management and Biostatistics on data review plans and interpretation of early-phase data.
- Contribute to ensuring data quality and readiness for interim analyses and regulatory interactions.
- Support feasibility assessments, including enrollment considerations and study design optimization.
- Partner closely with Clinical, Translational Sciences, Regulatory, Biomarkers, and Clinical Pharmacology to advance early programs.
- Contribute to alignment with external stakeholders including investigators, CROs, and academic collaborators.
Required Qualifications:
- Advanced scientific degree required (MD, PhD, PharmD, or equivalent).
- 6+ years of clinical development experience in the biotechnology or pharmaceutical industry or equivalent, preferably in immunology.
- Ability to survey and interpret scientific literature related to assigned projects.
- Strong interpersonal skills and ability to collaborate across internal teams and with external clinical partners.
- Strong analytical skills coupled with excellent oral and written communication skills to present findings and relevant data.
- Strong organizational skills and ability to thrive in a fast-paced environment.