Associate Director, CMC / Quality Project Management

Summit Therapeutics•Princeton, NJ

About The Position

The Associate Director, CMC / Quality Project Management is an individual-contributor role that provides program leadership for CMC and Quality activities, with a prioritized focus on CMC, supply, quality, and business activities. The role helps build the Program Management department’s infrastructure, tools, and processes and provides strategic and operational leadership for CMC and Quality deliverables throughout the biologics development lifecycle, from early clinical phases through BLA submission and post-approval changes. Working in a matrixed environment, the Associate Director collaborates with Process Development, Analytical Development, Quality, Regulatory Affairs, Manufacturing, and external partners such as CDMOs and CROs to support high-quality regulatory submissions and commercialization readiness. The position represents Program Management in cross-functional teams, supports program and governance decisions, and develops plans, timelines, risk strategies, reports, and presentations for teams and senior leaders. It also oversees external CMC partners and clinical-supply planning, including work with external collaborators. Limited travel may be required, including global travel, and the role requires flexibility for virtual meetings across time zones.

Requirements

Bachelor’s degree in life sciences, chemistry, engineering, or a related field.
At least 8 years of experience in the pharmaceutical or biotechnology industry, with substantial experience in CMC development, late-stage biologics, and regulatory filing preparation (BLA, MAA).
Prior pharmaceutical drug-development experience.
Proven success leading global, matrixed, cross-functional teams in a regulated environment.
Strong skills in integrated project planning, risk management, resource allocation, and budget oversight.
Proficiency with the MS Office suite, including PowerPoint, Word, Excel, and Project.
Experience using electronic document-management systems and document-review tools, and ability to quickly build presentations for leaders and teams.
Excellent public-speaking, meeting-facilitation, and written communication skills, including email communication.
Ability to excel in a fast-paced, demanding, and diverse environment.
Flexibility for global virtual meetings across different time zones.
Ability to travel globally may be needed, including to the EU, and to meet Chinese visa requirements.

Nice To Haves

Advanced degree such as an MS, PharmD, PhD, or MBA.
Professional proficiency in Mandarin to facilitate communication with overseas collaborators.
PMP certification.
Experience with Smartsheet, MS Project, Power BI, Office Timeline, or similar tools.
Late-stage-to-commercialization experience and biologics experience.
Late-stage oncology development experience and understanding of GMP, manufacturing, and global regulatory supply chains.

Responsibilities

Represent the Program Management department in cross-functional teams with clinical development, non-clinical, and/or regulatory focus.
Develop and maintain detailed CMC submission plans, timelines, and risk-mitigation strategies for BLA and other regulatory filings.
Prepare presentations, decision memos, and status reports for senior management and governance forums.
Implement and refine program tools, workflows, and processes to improve the efficiency, transparency, and quality of CMC operations.
Align CMC strategy for early-stage IND/IMPD and late-stage biologics suitable for BLA/MAA filings, including characterization, control strategy, comparability, stability, and regulatory expectations.
Align CMC deliverables with project milestones and product target profile through data-driven and risk-based decision-making.
Participate in cross-functional governance and steering committees to influence and guide program direction.
Develop decision-quality approaches, including options and trade-off assessments, within assigned areas.
Identify, track, and mitigate risks, and identify opportunities that may accelerate project success.
Develop, implement, and maintain CMC plans for assigned activities, including scenario planning, dashboards, reports, and timelines integrated into overall program plans.
Communicate CMC plans to cross-functional teams and leadership.
Provide clinical-supply inputs to development scenarios, clinical-supply forecasts, vendor plans, and governance decisions, balancing patient needs, feasibility, cost, inventory, expiry, and supply risk.
Support clinical-trial start-up and execution by tracking critical supply dependencies and escalating issues that could affect first-patient-in, site activation, enrollment, or dosing continuity.
Serve as the primary CMC project-management interface for CDMOs/CMOs performing drug-substance, drug-product, and analytical-testing work.
Monitor CDMO performance against KPIs, including batch production and release, deviation closure, and CAPA effectiveness, and proactively escalate risks.
Serve as the CMC/Supply project-management liaison for external study collaborations, integrating partner assumptions and timelines into internal program plans.
Facilitate cross-company risk reviews, scenario assessments, issue resolution, and governance decisions to support alignment on study readiness and continuity of clinical supply.
Lead CMC and clinical-supply program management for collaborative clinical studies with external partners by establishing joint plans, governance cadence, roles, decision rights, milestones, dependencies, deliverables, and escalation pathways aligned with contractual obligations and program objectives.
Perform other duties as assigned.