I
Not Specified Permanent

Seattle, Washington · USA job

Director, Program Management

Immunome

Seattle, Washington

This job is no longer available — it was removed from the JobsMint Pro catalog and cannot be applied to. Location: Seattle, Washington · 98101

Job description

Overview

In this role you will drive cross-functional planning and execution for two assets across development stages. You will own the integrated development plan for the first ADC program as it transitions from early to late-stage, and also manage an early-stage radiopharmaceutical asset from candidate selection through IND-enabling activities. You will help shape the program management operating model and enable data-driven governance to support a growing pipeline. You will partner with R&D, CMC, Regulatory, Clinical, Quality, and external partners to translate strategy into actionable plans and decision-ready updates.

Responsibilities
  • Own the integrated development plan for the first ADC asset across clinical, nonclinical, CMC, and regulatory workstreams.
  • Evolve the transition from early to late-stage development with governance cadence and staffing changes to meet late-stage needs.
  • Maintain the integrated program timeline and critical path, identifying sequencing conflicts and long-lead items.
  • Prepare for stage-gates and regulatory interactions with decision-ready materials.
  • Manage the early-stage radiopharmaceutical program from candidate selection to IND-enabling activities and early clinical evaluation.
  • Develop the early development plan covering discovery, nonclinical, CMC, regulatory strategy, and first-in-human readiness.
  • Coordinate cross-functional workstreams into a single critical path and drive IND stage-gate readiness.
  • Plan for radiopharmaceutical-specific operational and supply considerations.
  • Represent CMC on the core product development team and own CMC deliverables, timelines, and risks.
  • Liaise with contract manufacturing organizations and external partners; manage scope, deliverables, and schedule adherence.
  • Direct the CMC budgeting process and manage spend to target.
  • Coordinate and facilitate cross-functional meetings, capture decisions, and hold teams to commitments.
  • Communicate program status to stakeholders and prepare dashboards and executive updates.
  • Identify and mitigate program risks across technical, operational, supply, and regulatory dimensions.
  • Develop budgets with Finance, manage resource planning, and protect critical path.
  • Ensure complete and compliant documentation, adhering to regulatory requirements and GxP standards.
  • Develop and improve the program management operating model, templates, and tools across the portfolio.
  • Support additional PMO projects as the company grows.
Key requirements
  • 8 to 10 years of project and program management experience in biotechnology or pharmaceutical industry
  • Experience across multiple development stages and transitioning from early to late-stage
  • Direct hands-on CMC project management, including manufacturing timelines and external partnerships
  • Proven track record in leading cross-functional core teams in a matrixed environment
  • Strong knowledge of drug development functions, regulatory expectations, and industry standards (FDA/EMA)
  • Excellent cross-functional communication and relationship-building skills
  • Ability to manage multiple priorities in a fast-paced setting; strong problem-solving and decision-making abilities
  • Proficiency with project management tools (Smartsheet, MS Project, Asana) and MS Office Suite
  • Preferred: antibody-drug conjugates, radiopharmaceuticals, oncology development, regulatory submissions (IND/CTA) and experience in a biotech environment
  • Bachelor's degree in a technical or scientific field; advanced degree or PMP desirable
  • cross-functional collaboration
  • influencing at all levels
  • problem solving
  • Smartsheet
  • MS Project
  • Asana

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