Associate Director, CMC/Quality Project Management (Biologics)

Summit Therapeutics plc • Princeton, NJ

56d • $153,000 - $180,000

About The Position

About Summit 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 eg 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 Summits 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 lifecyclefrom 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 CDMOsCROs 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 departmentcompany grow

Requirements

• Bachelors degree in life sciences chemistry engineering or related field required; advanced degree MS PharmD PhD MBA desirable
• Minimum of 8 years in pharmaceuticalbiotech 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
• 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
• Excellent communicator in public speaking meeting facilitation and email communication
• Ability to excel in a fast paced demanding and diverse environment

Nice To Haves

• Preferred Language Professional proficiency in Mandarin is strongly preferred to facilitate communication with overseas collaborators
• Prior oncology experience in late stage development and understanding of GMP manufacturing and global regulatory supply chains preferred
• Project experience using electronic document management systems document review tools and can quickly build presentations for leadersteams

Responsibilities

• Cross functional Collaboration and CMC Leadership Represent the Program Management department in cross functional teams with clinical development non clinical andor regulatory focus
• Integrate Analytical DevelopmentQuality 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 INDIMPD 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 CDMOCMO Oversight & External Network Management Serve as the primary CMC PM interface for CDMOsCMOs 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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Chemical Manufacturing