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.

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

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

program managementcross-functional planningbusiness requirements coordinationsystem designprocess optimizationregulatory submissionsvendor managementdata analysisproject executionrisk management

Soft Skills

strategic thinkingcommunicationleadershipcollaborationchange managementcoachingstorytellingorganizational awarenessproblem-solvingteam development

Certifications

Six SigmaLEANPMPAgile