Senior Director, Oncology Clinical Development, Early Phase (mRNA)

Location: Cambridge, Massachusetts, United States. The role follows a 70/30 in-office work model. Due to export-control requirements, only U.S. persons are eligible, and visa sponsorship is not available.

Salary: $210,900–$379,200 per year, with potential bonus, incentive compensation, or equity award.

Company

hirify.global develops mRNA-based medicines through its mRNA technology platform.

What you will do

• Lead clinical development programs for one or more early-phase oncology mRNA precision immunotherapies.
• Develop clinical development plans and optimize study designs using scientific, regulatory, product, and commercial inputs.
• Write protocols, establish timelines and Go/No Go criteria, oversee execution, and provide medical monitoring.
• Generate clinical evidence on efficacy, safety, differentiation, patient value, and probability of technical success.
• Lead clinical development discussions with regulators and support IND, NDA, BLA, and MAA submissions.
• Collaborate with translational medicine, pharmacometrics, research, biostatistics, clinical operations, regulatory, commercial, CRO, and external expert teams.

Requirements

• MD, DO, or non-U.S. equivalent degree with relevant hematology and/or oncology experience in an academic or hospital environment.
• At least 3 years of oncology drug development experience in the biopharmaceutical industry; in exceptional cases, at least 5 years as an early-phase clinical trialist in academia may be considered.
• Experience leading cross-functional teams and complex clinical development workstreams.
• Strong knowledge of clinical research methodology, biostatistics, clinical and non-clinical study design, and the full drug development process.
• Thorough command of FDA, MHRA, and ICH GCP guidelines, including clinical study conduct, audits, and regulatory inspections.
• Must qualify as a U.S. person under U.S. export-control laws; non-U.S. persons cannot be sponsored for an export-control license.

Nice to have

• Medical oncology and/or hematology fellowship training.
• Experience with oncology or hematology immunotherapeutics.
• Experience conducting translationally rich oncology or hematology clinical trials.
• Experience using digital tools and innovative methods in clinical development.

Culture & Benefits

• In-person collaboration, mentorship, and cross-functional teamwork supported through the 70/30 work model.
• Competitive healthcare and voluntary benefit programs.
• Fitness, mindfulness, mental health, family planning, fertility, adoption, and surrogacy support.
• Paid vacation, volunteer days, sabbatical, global recharge days, and year-end shutdown.
• Savings and investment programs, plus location-specific perks.