Executive Director, Clinical Development Lead (Oncology)

Location: Cambridge, Massachusetts, United States; 70% in-office work model

Salary: $243,100–$437,000 annually, with potential bonus, incentive compensation, or equity.

Company

hirify.global develops medicines using its mRNA technology platform.

What you will do

• Lead clinical development strategy and clinical development plans for oncology assets.
• Design clinical studies, write protocols, establish timelines and decision criteria, and oversee medical monitoring and execution.
• Lead clinical development discussions for regulatory submissions, including IND, BLA, and MAA materials.
• Integrate scientific, clinical, regulatory, commercial, and patient-need considerations into target product profiles and development decisions.
• Collaborate with Research, Regulatory, Clinical Operations, Statistics, Commercial, external experts, pharmaceutical partners, and CROs.
• Coach and mentor Clinical Sciences staff, with potential direct line management responsibility.

Requirements

• U.S. person status is required due to U.S. export control regulations; non-U.S. persons cannot be sponsored for an export control license.
• M.D. with at least 8 years of oncology drug development experience in the biopharmaceutical industry, or a medical oncologist with 10+ years of clinical development experience including at least 5 years in biopharma.
• Experience in oncology or immuno-oncology clinical drug development and leading clinical trial design and execution.
• Experience leading cross-functional teams across translational medicine, biostatistics, regulatory, preclinical pharmacology, and pharmaceutical sciences.
• Strong knowledge of clinical research methodology, biostatistics, the drug development process, and data-driven clinical trial planning.
• Excellent communication, analytical, problem-solving, strategic planning, organization, and complex project management skills.

Nice to have

• Experience with translational medical approaches in development programs.
• Experience using AI, machine learning, and digital technologies in oncology clinical development.
• Experience with cGCP audits, regulatory inspections, and FDA, MHRA, and ICH GCP guidelines.

Culture & Benefits

• In-person collaboration model with direct mentorship and cross-functional teamwork.
• Healthcare and voluntary benefit programs, including fitness, mindfulness, and mental health support.
• Family planning support covering fertility, adoption, and surrogacy.
• Paid vacation, volunteer days, sabbatical, global recharge days, and discretionary year-end shutdown.
• Savings and investment programs plus location-specific benefits.