Summit Therapeutics Sub, Inc.
Associate Director, CMC/Quality Project Management (Biologics)
Summit Therapeutics Sub, Inc., Princeton, New Jersey, us, 08543
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Associate Director, CMC/Quality Project Management (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 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. This 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. They will provide 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, this position will collaborate across Process Development, Analytical Development, Quality, Regulatory Affairs, Manufacturing, external partners (CDMOs/CROs) to deliver high-quality submissions and commercialization readiness. This role requires flexible, execution-focused capabilities with the ability to take on additional responsibilities as the department/company grow. 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 Integrate Analytical Development/Quality Control (QC), Drug Product development and manufacturing, and end-to-end Supply Chain to ensure robust control strategies, inspection readiness, and reliable supply. 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 Can quickly build strong and sustaining relationships with stakeholders at all levels Lead key activities or assigned projects, which may rapidly evolve based on business needs 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. Monitor global regulatory trends (FDA, EMA, PMDA, ICH) to anticipate changes and manage compliance strategies in submissions. 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 Lead assigned internal and external communications outputs. CDMO/CMO Oversight & External Network 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. Drive method transfer, tech transfer, and validation activities at CDMOs to meet regulatory and program 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 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: Minimum of 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. The pay range for this role is $153,000-$180,000 annually. 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. 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.
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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 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. This 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. They will provide 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, this position will collaborate across Process Development, Analytical Development, Quality, Regulatory Affairs, Manufacturing, external partners (CDMOs/CROs) to deliver high-quality submissions and commercialization readiness. This role requires flexible, execution-focused capabilities with the ability to take on additional responsibilities as the department/company grow. 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 Integrate Analytical Development/Quality Control (QC), Drug Product development and manufacturing, and end-to-end Supply Chain to ensure robust control strategies, inspection readiness, and reliable supply. 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 Can quickly build strong and sustaining relationships with stakeholders at all levels Lead key activities or assigned projects, which may rapidly evolve based on business needs 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. Monitor global regulatory trends (FDA, EMA, PMDA, ICH) to anticipate changes and manage compliance strategies in submissions. 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 Lead assigned internal and external communications outputs. CDMO/CMO Oversight & External Network 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. Drive method transfer, tech transfer, and validation activities at CDMOs to meet regulatory and program 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 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: Minimum of 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. The pay range for this role is $153,000-$180,000 annually. 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. 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.
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