Associate Director, CMC / Quality Project Management

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 China's National Medical Products Administration (NMPA). Summit is headquartered in Miami, Florida, and has additional offices in California, New Jersey, the UK, and Ireland.

The Associate Director, Project Management (CMC, Quality) is an individual contributor position that will play a critical role in driving the success of Summit programs and with prioritized focus in CMC, Supply, Quality and Business activities.

Role will provide CMC / Quality program leadership in cross-functional team settings and will help build the infrastructure, tools and processes contributing to the success of Program Management department. 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.

Working within a matrixed environment, you will collaborate across Process Development, Analytical Development, Quality, Regulatory Affairs, Manufacturing, external partners (CDMOs/CROs) to deliver high-quality submissions and commercialization readiness. If you enjoy the excitement and intensity of senior leader engagements where assignments may deeply embed you with targeted functions or teams, then this is the role for you!

Role and Responsibilities

• Cross-functional Collaboration and CMC Leadership
• 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 high-impact presentations, decision memos, and status reports for senior management and governance forums
• Implement and refine program tools, workflows, and processes to enhance efficiency, transparency, and quality of CMC operations
• Strategic Responsibilities:
• Ensure alignment in CMC strategy for early stage IND/IMPD and late-stage biologics suitable for BLA/ MAA filings (including characterization, control strategy, comparability, stability, regulatory expectations)
• Ensure alignment of CMC deliverables with project milestones and product target profile through data-driven and risk-based decision-making
• Engage in cross-functional governance and steering committees to influence and guide program direction.
• Project Management
• Maintain decision-quality approaches within assigned areas with options and trade-off assessments
• Actively identify, track and mitigate risks, to include opportunity creation that may accelerate project success
• Develop, implement and maintain CMC plans for assigned activities, to include scenario planning, dashboards, reports and timelines that integrate into overall Program Plans. Communicate CMC plans to cross-functional team and leadership
• Provide clinical supply inputs to development scenarios, clinical supply forecast, 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 ensuring timely escalation of issues that could affect first-patient-in, site activation, enrollment, dosing continuity.
• CDMO/CMO Oversight & External Collaboration Management
• Serve as the primary CMC PM interface for CDMOs/CMOs performing drug substance, drug product, and analytical testing.
• Monitor CDMO performance against KPIs (batch production and release, deviation closure, CAPA effectiveness) and escalate risks proactively.
• Serve as the CMC/Supply PM 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 maintain alignment on study readiness and continuity of clinical supply.
• Lead CMC and clinical supply program management for collaborative clinical studies with external partners, establishing joint plans, governance cadence, roles, decision rights, milestones, dependencies, deliverables, and escalation pathways aligned with contractual obligations and overall program objectives.
• Limited travel may be required depending on assigned activities or projects, plus flexibility for global virtual meetings in different time zones. Ability to travel globally may be needed, including EU and meeting Chinese Visa requirements.
• All other duties as assigned

Experience, Education and Specialized Knowledge and Skills

• Education: Bachelor's degree in life sciences, chemistry, engineering, or related field required; advanced degree (MS, PharmD, PhD, MBA) desirable.
• Experience: 8+ years in pharmaceutical/biotech industry, with substantial experience in CMC development, late-stage biologics, and regulatory filing preparation (BLA, MAA)
• Leadership: Proven success leading global, matrixed, cross-functional teams in a regulated environment
• Preferred Language: Professional proficiency in Mandarin is strongly preferred to facilitate communication with overseas collaborators.
• Project Management: Strong skills in integrated project planning (PMP certified), risk management, resource allocation, and budget oversight. Experience with tools like Smartsheet, MS Project, Power BI, Office Timeline etc., is beneficial.
• Prior pharmaceutical (drug development) experience required, late-stage to commercialization phase experience and biologics preferred
• Prior oncology experience in late-stage development and understanding of GMP, manufacturing and global regulatory supply chains preferred
• Proficient user of MS Office suite (e.g., PowerPoint, Word, Excel, Project), experience using electronic document management systems, document review tools and can quickly build presentations for leaders/teams
• Excellent communicator in public-speaking, meeting facilitation and email communication
• Ability to excel in a fast-paced, demanding and diverse environment.

This is the pay for this position

Pay Transparency $174,000 - $204,000 USD

Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to skill set, depth of experience, certifications, and specific work location. This may be different in other locations due to differences in the cost of labor. The total compensation package for this position may also include bonus, stock, benefits and/or other applicable variable compensation.

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