Director, Submission Project Management Lead

Location: Foster City, California, United States

Salary: $226,185–$292,710 annually in the Bay Area; other US locations: $205,615–$266,090 annually. Additional eligibility may include an annual bonus, stock-based long-term incentives, paid time off, and benefits.

Company

hirify.global is a biopharmaceutical company developing cancer immunotherapies, including CAR T-cell and T-cell receptor engineered cell therapies.

What you will do

• Lead end-to-end planning, readiness, and execution for BLAs, sBLAs, and other major global regulatory filings.
• Coordinate clinical data generation, database lock, data review, statistical analyses, clinical study report inputs, and regulatory submission components.
• Align Clinical Development, Clinical Operations, Data Management, Biostatistics, Statistical Programming, Regulatory Affairs, Medical Writing, Translational Sciences, Safety, and Quality teams.
• Manage critical paths, dependencies, risks, milestones, governance, performance metrics, dashboards, and forecasting tools.
• Identify process improvements that reduce time-to-filing while maintaining quality, inspection readiness, and regulatory compliance.
• Provide executive-ready communications and targeted Global Project Manager support for Product Teams and Development sub-teams.

Requirements

• Doctorate plus 6 years, Master’s plus 10 years, or Bachelor’s plus 12 years of pharmaceutical, biotechnology, or relevant industry experience.
• Extensive experience supporting late-stage development and major regulatory submissions.
• Experience leading complex filings such as BLAs, sBLAs, NDAs, MAAs, or equivalent global submissions.
• Strong understanding of clinical trial execution, clinical data generation, data management, statistical analysis, medical writing, safety, quality, and regulatory processes.
• Demonstrated ability to lead large cross-functional initiatives and influence senior leadership in a matrixed organization.
• Experience with project management, submission planning, clinical data, governance, timeline, or enterprise portfolio tools.

Nice to have

• Oncology, hematology, cell therapy, or advanced therapeutics experience.
• Experience as a Global Project Manager, program lead, or equivalent operational leader.
• PMP, operational excellence, Lean Six Sigma, or related certification.
• Experience leading continuous improvement initiatives.

Culture & Benefits

• Work in a mission-driven environment focused on developing treatments for cancer.
• Lead and develop talent while fostering inclusion and empowering teams.
• Company-sponsored medical, dental, vision, and life insurance plans.
• Paid time off and potential annual bonus and stock-based long-term incentives.