Director, Clinical Scientist & Operations - Immunology

HotSpot Therapeutics, Inc.; Boston (MA); Hybrid; USD 180,000 - 240,000; Full time

Benefits offered by this job

Competitive salary and bonus plans

Comprehensive benefits package

Generous paid holidays and time off

Supportive team environment

Job summary

HotSpot Therapeutics, Inc. seeks a highly collaborative Director, Clinical Scientist and Operations to shape early clinical development programs in immunology.

This hybrid role bridges Clinical Sciences, Clinical Operations, Translational Sciences, and Discovery—driving biomarker strategies, study execution, and key program milestones. In this position you will provide scientific leadership, oversee CROs and clinical sites, ensure safety and data integrity, and contribute to regulatory

Qualifications

• 10+ years of clinical development and/or operations experience in pharma/biotech.
• Strong scientific track record in Immunology.
• Experience managing external CROs, central labs, and clinical sites.
• Cross-functional collaboration skills in a fast-paced setting.
• Excellent oral and written communication; able to balance strategy and hands-on work.

Responsibilities

• Provide scientific and clinical study support from start-up through CSRs.
• Oversee study enrollment and ensure timelines and goals are met.
• Lead clinical biomarker strategies and data delivery from samples.
• Interpret safety/efficacy data and communicate findings.
• Ensure adherence to GCP, regulatory guidelines, and quality standards.
• Contribute to regulatory responses and meetings.
• Educate investigators, site personnel, and CRO partners.
• Prepare protocols, IBs, ICFs, and CSRs with cross-functional input.
• Lead CRO/vendor selection, budgets, plans, and timelines.
• Manage budgets and vendor agreements; ensure compliant change orders.
• Implement clinical trial operational plans; develop CRFs, EDC, IRT training.
• Review data completeness and maintain data fidelity in study conduct.

Education

Bachelor's Degree in biology/immunology

Master’s degree in related field

Advanced degree preferred

Job description

HotSpot Therapeutics, Inc. seeks a highly collaborative Director, Clinical Scientist and Operations to shape early clinical development programs in immunology.

This hybrid role bridges Clinical Sciences, Clinical Operations, Translational Sciences, and Discovery—driving biomarker strategies, study execution, and key program milestones. In this position you will provide scientific leadership, oversee CROs and clinical sites, ensure safety and data integrity, and contribute to regulatory