Director, Project Management - CMC

Summit Therapeutics Sub•Princeton, NJ

22h•$184,000 - $230,000•Onsite

About The Position

About Summit: Summit Therapeutics Inc. is a biopharmaceutical oncology company with a mission focused on improving quality of life, increasing potential duration of life, and resolving serious unmet medical needs. At Summit, we believe in building a team of world class professionals who are passionate about this mission, and it is our people who drive this mission to reality. Summits core values include integrity, passion for excellence, purposeful urgency, collaboration, and our commitment to people. Our employees are truly the heart and soul of our culture, and they are invaluable in shaping our journey toward excellence. Summits team is inspired to touch and help change lives through Summits clinical studies in the field of oncology. Summit has multiple global Phase 3 clinical studies, including: Non-small Cell Lung Cancer (NSCLC) HARMONi: Phase 3 clinical study which was intended to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who were previously treated with a 3rd generation EGFR TKI. HARMONi-3: Phase 3 clinical study which is intended to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic NSCLC. HARMONi-7: Phase 3 clinical study which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC. Colorectal Cancer (CRC) HARMONi-GI3: Phase 3 clinical study intended to evaluate ivonescimab in combination with chemotherapy compared with bevacizumab plus chemotherapy. Ivonescimab is an investigational therapy not presently approved by any regulatory authority other than Chinas National Medical Products Administration (NMPA). Summit is headquartered in Miami, Florida, and has additional offices in California, New Jersey, the UK, and Ireland. Overview of Role: The Director, Project Management role will ensure robust planning and execution, of drug product development for global commercial supply. Reporting to the VP of Project Management, this position is responsible for the hands-on management and execution of CMC, manufacturing, and supply chain projects that support the reliable, compliant, and cost-effective commercial supply of pharmaceutical products. This role focuses on day-to-day project execution, ensuring defined scope, timelines, budgets, and quality objectives are met across the commercial product lifecycle.

Requirements

Bachelors degree required; advanced degree (MBA, MS, PhD, PharmD) strongly preferred.
10+ years of experience in project management, operational excellence, reporting, and performance management within biopharmaceutical or life sciences organizations.
5+ years of direct project management experience supporting commercial manufacturing and supply
Proven ability to translate complex data into executive-ready insights.
Expertise in project management and process improvement methodologies (PMP, Lean, Six Sigma, Agile).
Strong analytical mindset
Change leadership in fast-paced, evolving environments
Proven ability to influence senior stakeholders and drive accountability without direct authority.
Willingness to travel 30-50% of the time.

Nice To Haves

Prior experience in pre-commercial or early commercial biotech/pharma strongly preferred.

Responsibilities

Lead commercial supply related projects from initiation through completion, including lifecycle changes, capacity expansions, site transfers, and continuous improvement initiatives.
Develop and manage detailed project plans, schedules, budgets, and resource forecasts for commercial supply projects.
Track progress against milestones and deliverables; proactively manage risks, issues, and change control.
Ensure projects are delivered on time, within scope, and in compliance with regulatory and quality requirements .
Manage CMC projects supporting post-approval changes, process improvements, scale-up, validation, and product lifecycle management.
Lead projects supporting commercial manufacturing readiness, capacity optimization, sourcing changes, and network resilience.
Coordinate change implementation in alignment with global regulatory filing strategies and health authority commitments .
Ensure alignment between project execution and ongoing commercial supply operations .
Support launch sustainment, inventory strategies, and mitigation of supply risks .
Ensure design of executive-ready dashboards clearly communicate status, trends, risks, and performance against projects, OKRs and enterprise initiatives.
Work closely with Program Management Support reporting cadences for executive leadership, governance forums, and cross-functional reviews.
Ensure alignment between project execution and ongoing commercial supply operations.
Enable leadership to make informed decisions based on execution performance, risk, and value.
Partner with IT, and functional teams to ensure data accuracy, consistency, and automation of dashboards and reports.
Evaluate and recommend tools and platforms to support scalable reporting and analytics.
Act as a senior partner to assigned functional leadership on execution strategy, planning, and risk management.
Drive accountability across functional leaders for milestones, deliverables, and outcomes.
Apply structured methodologies (Lean, Six Sigma, Agile, hybrid) to improve efficiency, predictability, and scalability.
Build enterprise capability in disciplined project execution, metrics literacy, and data-driven decision-making.
Foster a culture of accountability, transparency, and continuous improvement.
All other duties as assigned.