Summit Therapeutics Sub, Inc.
Senior Director, CMC Strategy Development & Delivery
Summit Therapeutics Sub, Inc., Princeton, New Jersey, us, 08543
Career Opportunities with Summit Therapeutics Sub, Inc.
All candidates should make sure to read the following job description and information carefully before applying. A great place to work. Careers at Summit Therapeutics Sub, Inc. Current job opportunities are posted here as they become available. Ivonescimab, known as SMT112, is a novel, potential first-in-class investigational bispecific antibody combining immunotherapy via PD-1 blockade with anti-angiogenesis effects by blocking VEGF. It exhibits unique cooperative binding with higher affinity when targeting both PD-1 and VEGF. Summit has initiated clinical development of ivonescimab in non-small cell lung cancer (NSCLC), with three active Phase III trials: HARMONi : A Phase III trial evaluating ivonescimab with chemotherapy versus placebo with chemotherapy in EGFR-mutated, locally advanced or metastatic non-squamous NSCLC patients who progressed after third-generation EGFR TKI treatment. HARMONi-3 : A Phase III trial assessing ivonescimab with chemotherapy versus pembrolizumab with chemotherapy as first-line treatment for metastatic NSCLC. HARMONi-7 : A Phase III trial comparing ivonescimab monotherapy versus pembrolizumab monotherapy in first-line metastatic NSCLC with high PD-L1 expression. Ivonescimab is an investigational therapy not yet approved in the US or Europe, but was approved in China in May 2024. It has received Fast Track designation from the FDA for the HARMONi trial. Overview of Role: The Senior Director of CMC Strategy Development & Delivery will lead the development and execution of CMC strategies to support the ongoing process development, manufacturing, clinical supply, regulatory filings, and launch of Ivonescimab. Responsibilities include: Developing comprehensive CMC strategies aligned with regulatory standards. Ensuring timely achievement of strategic objectives such as process improvements, manufacturing site introductions, and commercial readiness. Leading cross-functional initiatives to optimize development and supply chain processes. Collaborating with stakeholders to align strategies with business and development timelines. Identifying and executing strategic partnerships to enhance capabilities. Overseeing technology transfer processes for seamless transition to manufacturing. Addressing regulatory and logistical challenges proactively. Staying updated on industry trends and integrating innovative approaches. Representing the company in high-level discussions with regulatory and industry partners. Preparing strategic reports for senior management and the board. Performing other duties as assigned. Qualifications and Skills: Bachelor’s degree in Chemistry, Biochemistry, Biotechnology, Chemical Engineering, or related; advanced degrees preferred. At least 12 years of experience in CMC and supply chain strategy within biopharmaceuticals, especially monoclonal antibodies. Successful track record in product transfers, regulatory filings, and launches preferred. Strong leadership and strategic thinking skills. Deep knowledge of regulatory requirements and industry standards. Excellent problem-solving and decision-making skills. Effective communication and interpersonal skills. Ability to thrive in a fast-paced environment. The salary range for this role is $221,000 to $277,000 annually, with total compensation including bonuses, stock, and benefits depending on experience and other factors. Summit does not accept referrals from employment agencies without prior authorization. Contact recruiting@smmttx.com for referral procedures.
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All candidates should make sure to read the following job description and information carefully before applying. A great place to work. Careers at Summit Therapeutics Sub, Inc. Current job opportunities are posted here as they become available. Ivonescimab, known as SMT112, is a novel, potential first-in-class investigational bispecific antibody combining immunotherapy via PD-1 blockade with anti-angiogenesis effects by blocking VEGF. It exhibits unique cooperative binding with higher affinity when targeting both PD-1 and VEGF. Summit has initiated clinical development of ivonescimab in non-small cell lung cancer (NSCLC), with three active Phase III trials: HARMONi : A Phase III trial evaluating ivonescimab with chemotherapy versus placebo with chemotherapy in EGFR-mutated, locally advanced or metastatic non-squamous NSCLC patients who progressed after third-generation EGFR TKI treatment. HARMONi-3 : A Phase III trial assessing ivonescimab with chemotherapy versus pembrolizumab with chemotherapy as first-line treatment for metastatic NSCLC. HARMONi-7 : A Phase III trial comparing ivonescimab monotherapy versus pembrolizumab monotherapy in first-line metastatic NSCLC with high PD-L1 expression. Ivonescimab is an investigational therapy not yet approved in the US or Europe, but was approved in China in May 2024. It has received Fast Track designation from the FDA for the HARMONi trial. Overview of Role: The Senior Director of CMC Strategy Development & Delivery will lead the development and execution of CMC strategies to support the ongoing process development, manufacturing, clinical supply, regulatory filings, and launch of Ivonescimab. Responsibilities include: Developing comprehensive CMC strategies aligned with regulatory standards. Ensuring timely achievement of strategic objectives such as process improvements, manufacturing site introductions, and commercial readiness. Leading cross-functional initiatives to optimize development and supply chain processes. Collaborating with stakeholders to align strategies with business and development timelines. Identifying and executing strategic partnerships to enhance capabilities. Overseeing technology transfer processes for seamless transition to manufacturing. Addressing regulatory and logistical challenges proactively. Staying updated on industry trends and integrating innovative approaches. Representing the company in high-level discussions with regulatory and industry partners. Preparing strategic reports for senior management and the board. Performing other duties as assigned. Qualifications and Skills: Bachelor’s degree in Chemistry, Biochemistry, Biotechnology, Chemical Engineering, or related; advanced degrees preferred. At least 12 years of experience in CMC and supply chain strategy within biopharmaceuticals, especially monoclonal antibodies. Successful track record in product transfers, regulatory filings, and launches preferred. Strong leadership and strategic thinking skills. Deep knowledge of regulatory requirements and industry standards. Excellent problem-solving and decision-making skills. Effective communication and interpersonal skills. Ability to thrive in a fast-paced environment. The salary range for this role is $221,000 to $277,000 annually, with total compensation including bonuses, stock, and benefits depending on experience and other factors. Summit does not accept referrals from employment agencies without prior authorization. Contact recruiting@smmttx.com for referral procedures.
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