Senior CMC Project Manager (Biologics)
Location: Princeton, NJ or Oxford, UK (on-site)
Summit Therapeutics, Inc. is seeking a Senior CMC Project Manager (Biologics). Ivonescimab, known as SMT112, is a novel, potential first‑in‑class investigational bispecific antibody combining the effects of immunotherapy via a blockade of PD‑1 with the anti‑angiogenesis effects associated with blocking VEGF into a single molecule. Ivonescimab displays unique cooperative binding to each of its intended targets with multifold higher affinity when in the presence of both PD‑1 and VEGF. Summit has begun its clinical development of ivonescimab in non‑small cell lung cancer (NSCLC), with three active Phase III trials:
* HARMONi is a Phase III clinical trial which intends to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR‑mutated, locally advanced or metastatic non‑squamous NSCLC who have progressed after treatment with a 3rd generation EGFR TKI (e.g., osimertinib).
* HARMONi‑3 is a Phase III clinical trial which is designed to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first‑line metastatic NSCLC.
* HARMONi‑7 is a Phase III clinical trial which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first‑line metastatic NSCLC whose tumors have high PD‑L1 expression.
Ivonescimab is an investigational therapy that is not approved by any regulatory authority in Summit’s license territories, including the United States and Europe. Ivonescimab was approved for marketing authorization in China in May 2024. Ivonescimab was granted Fast Track designation by the US Food & Drug Administration (FDA) for the HARMONi clinical trial setting.
Overview of Role
The Senior CMC Project Manager (Biologics) is an individual contributor position that will play a critical role driving the success of Summit programs and with prioritized focus in CMC, Supply, Quality and Business activities. This role requires a strong technical foundation in analytical development, drug product manufacturing, process validation (PPQ), and supply chain strategy, as well as proven experience managing external CDMOs and internal stakeholders in a matrixed environment. Role requires flexible, execution‑focused capabilities with the ability to take on additional responsibilities as the department/company grow.
Responsibilities
* Cross‑functional Collaboration and CMC Leadership
* Orchestrate CMC matrix teams (PD, AD, DP, MSAT, QA/QC, RA CMC, Supply Chain) across functions to deliver integrated project plans, timelines, and ensure milestone achievement.
* Build and maintain critical path roadmaps, scenarios, and resource/load views; ensure robust change control and decision logs.
* Prepare high‑impact presentations, decision memos, and status reports for senior management and governance forums.
* Can quickly build strong and sustaining relationships with stakeholders at all levels.
* Translate technical CMC topics into clear business impacts and options; enable fast, informed decisions.
* Implement and refine program tools, workflows, and processes to enhance efficiency, transparency, and quality of CMC operations.
* Strategic Responsibilities:
* Ensure alignment of 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 program 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
* Drive development, execution, and oversight of CMC strategies, including analytical method development and validation, drug substance and drug product process development, technology transfer, and process performance qualification (PPQ).
* 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 Project Plans. Communicate CMC plans to cross‑functional team and leadership.
* Lead assigned internal and external communications outputs.
* CDMO/CMO Oversight & External Network Management
* Serve as the primary CMC Quality PM interface for CDMOs/CMOs performing drug substance, drug product, and analytical testing.
* Monitor CDMO performance against KPIs (batch planning and release, deviation closure, CAPA effectiveness) and escape risks proactively.
* Drive method transfer, tech transfer, and validation activities at CDMOs to meet regulatory and project timelines.
* Support audit readiness and participate in vendor audits as needed.
* 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.
Qualifications
* 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 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.
Other Information
* Seniority level: Mid‑Senior level
* Employment type: Full‑time
* Job function: Strategy/Planning and Information Technology
Summit does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Summit’s Talent Acquisition team at recruiting@smmttx.com to obtain prior written authorization before referring any candidates to Summit.
#J-18808-Ljbffr