Director, Submission Excellence Technology Business Leader

Role Overview

• Serve as strategic thought partner to SubX leadership on priorities, roadmap, operating model, and budget; translate strategy into executable plans and quarterly OKRs.
• Stand up and run the SubX technology program office: governance cadence, meeting preparation, decision logs, action tracking to closure, and issue/risk management.
• Establish and monitor progress toward multi-year SubX technology key deliverables; intervene to remove roadblocks and keep critical-path items on track.
• Coordinate and consolidate business requirements for submission tools (e.g., biostats automation, document generation, QC/review, regulatory intelligence, publishing) and ensure they are delivered into solution designs and releases.
• Develop integrated, cross-functional plans spanning GRA, Medical Writing, Biostatistics, Regulatory Operations, Data Sciences, and JJT; align dependencies with other technology development programs.
• Oversee program portfolio, resources, and budget; support build/partner/buy evaluations and vendor management in partnership with Procurement and Finance.
• Prepare executive-ready status, dashboards, investment cases, CARs, and leadership presentations; ensure clear storytelling of value, risks, and decisions.
• Lead change management and communications for SubX at the program layer; enable initiative-level change/communications execution.
• Drive process optimization and adoption of new digital workflows; define success measures and monitor user experience, engagement, and compliance.
• Ensure alignment to standards and policies (e.g., eCTD, CDISC), responsible AI practices, and audit-ready documentation.
• Act as primary liaison to enabling functions (Finance, Procurement) to accelerate resourcing and contracting.
• Coach and develop a high-performing, diverse matrixed team (PMs, change partners, analysts, workstream leads); foster an agile, learning culture.

Requirements

• A minimum of a Bachelor's degree in a scientific, technical, IT or business related field is required.
• 10+ years of overall work experience, including 6+ years in the pharmaceutical/healthcare industry is required.
• A minimum of 6 years in a pharmaceutical/MedTech or comparable R&D area, with demonstrated organizational awareness and applied end-to-end (E2E) drug or medical device development knowledge is required.
• A track record leading complex, cross-functional programs and managing multiple workstreams from inception through close-out is required.
• Demonstrated ability to build cross-group plans, drive execution, and report progress; strong partner management and executive communication skills is required.
• Experience coordinating business requirements into system design/development and releases in partnership with technology teams is required.
• Relevant certifications such as Six Sigma, LEAN, PMP and/or Agile; demonstrated process transformation and culture change leadership is preferred.
• Experience with end-to-end process for operationalizing major regulatory submissions is preferred.
• Experience with IT system design, development and implementation; vendor/SOW management is preferred.

Tech Stack

• PMP

Benefits

• medical, dental, vision, life insurance
• short
• and long-term disability
• business accident insurance
• group legal insurance
• consolidated retirement plan (pension)
• savings plan (401(k))
• long-term incentive program
• Vacation –120 hours per calendar year
• Sick time
• 40 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
• Holiday pay, including Floating Holidays –13 days per calendar year
• Work, Personal and Family Time
• up to 40 hours per calendar year
• Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
• Condolence Leave – 30 days for an immediate family member: 5 days for an extended family member
• Caregiver Leave – 10 days
• Volunteer Leave – 4 days
• Military Spouse Time-Off – 80 hours