Associate Director, CMC / Quality Project Management

Summit Therapeutics•Princeton, NJ

1d•$174,000 - $204,000

About The Position

The Associate Director, Project Management (CMC, Quality) is an individual contributor who drives Summit programs, with a prioritized focus on CMC, supply, quality, and business activities. The role provides CMC and Quality program leadership in cross-functional teams and helps build the infrastructure, tools, and processes used by the Program Management department. The position provides strategic and operational leadership for CMC and Quality deliverables across the biologics development lifecycle, from early clinical phases through BLA submission and post-approval changes. 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 submissions and commercialization readiness. The role may involve close engagement with senior leaders and deep embedding with assigned functions or teams. Limited travel may be required, including international travel, and the position requires flexibility for global 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 preparation of regulatory filings such as BLA and MAA.
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.
Prior pharmaceutical drug development experience.
Proficiency with MS Office applications, including PowerPoint, Word, Excel, and Project.
Experience using electronic document management systems and document review tools, and ability to quickly prepare presentations for leaders and teams.
Excellent public-speaking, meeting-facilitation, and email communication skills.
Ability to excel in a fast-paced, demanding, and diverse environment.
Ability to travel globally may be needed, including to the EU, and to meet Chinese visa requirements.
Flexibility to participate in global virtual meetings across different time zones.

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 tools such as Smartsheet, MS Project, Power BI, or Office Timeline.
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 Program Management in cross-functional teams focused on clinical development, non-clinical development, and/or regulatory matters.
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 efficiency, transparency, and quality of CMC operations.
Ensure alignment of CMC strategy for early-stage IND/IMPD and late-stage biologics intended for BLA/MAA filings, including characterization, control strategy, comparability, stability, and regulatory expectations.
Align CMC deliverables with project milestones and product target profile using data-driven and risk-based decision-making.
Participate in cross-functional governance and steering committees to influence and guide program direction.
Maintain decision-quality approaches within assigned areas, including options and trade-off assessments.
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 with overall Program Plans; communicate these plans to cross-functional teams and leadership.
Provide clinical supply inputs to development scenarios, supply forecasts, vendor plans, and governance decisions, balancing patient needs, operational 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.
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 and facilitating cross-company risk reviews, scenario assessments, issue resolution, and governance decisions.
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.