Clinical Lead Early Clinical and Experimental Therapeutics

Location: Cambridge, Massachusetts, United States; hybrid. US and Puerto Rico residents only.

Salary: $206,250–$343,750 per year.

Company

hirify.global is an R&D-driven, AI-powered biopharmaceutical company developing medicines and vaccines through immunoscience, data, and digital technologies.

What you will do

• Design early clinical development and ECET plans across therapeutic areas and modalities, including small molecules, monoclonal antibodies, peptides, gene therapies, and nucleic acids.
• Design and conduct First-in-Human, First-in-Patient, natural history, mechanistic, signal-seeking, Proof-of-Mechanism, Proof-of-Concept, and pharmacokinetic studies.
• Supervise study execution, medical monitoring, dose selection, dose escalation, safety review, and Go/No Go decisions.
• Review and author protocols, informed consent forms, investigator brochures, regulatory documents, study reports, abstracts, manuscripts, and clinical study reports.
• Integrate research, toxicology, pharmacokinetic, modelling, biomarker, clinical, and operational inputs into translational medicine and human target validation plans.
• Lead cross-functional collaboration with internal teams, investigators, CROs, vendors, ethics committees, health authorities, and scientific experts.

Requirements

• M.D. or equivalent and postgraduate residency training.
• At least one year of experience designing and executing early development clinical trials, including Phase 1a/b and Phase 2a, or exploratory studies in pharmaceutical, academic, hospital, or CRO settings.
• Fluent English and excellent written and verbal communication skills.
• Experience working in matrix organizations and collaborating across clinical, research, regulatory, safety, pharmacology, and operational functions.
• Ability to make risk-managed decisions on protocol design, execution, dose escalation, and safety.
• Must be based in the United States or Puerto Rico and work in a hybrid arrangement in Cambridge, Massachusetts.

Nice to have

• M.D./Ph.D. and laboratory research experience in industry or academia.
• Knowledge of translational research and a broad biomedical background.
• Experience conducting late-phase clinical trials.
• Ability to apply new technical skills and digital or AI-driven solutions.

Culture & Benefits

• Supportive, future-focused environment centered on scientific innovation and collaboration.
• Opportunities for promotion, lateral moves, and international career development.
• Employee rewards, healthcare, wellbeing programs, and at least 14 weeks of gender-neutral parental leave.
• Work with patient insights, AI, data, and digital platforms to improve drug development.