Director, Clinical Scientist

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 (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 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:

We seek a dynamic Director, Clinical Scientist to lead innovation in clinical data management, standards governance, and technology implementation to streamline complex processes in data management and cleaning. In this strategic role, you will play a pivotal part in developing high-value therapeutics designed to meet critical medical needs.

You will oversee all aspects of clinical and lab data management across diverse phases of clinical trials, with a strong emphasis on oncology therapeutics. This includes driving CRF/eCRF design, database development and validation, comprehensive data review, discrepancy management, and ensuring timely database locks.

In close collaboration with the Head of Statistical Programming & Clinical Data Science, you will shape strategies surrounding DM vendor oversight, process automation, and the implementation of cutting-edge technologies. A key focus will be championing the exploration of open-source tools and AI/ML/GenAI solutions to enhance the efficiency and accuracy of data review and cleaning processes. Additionally, your expertise will guide the development and execution of company-wide clinical data standards, ensuring consistency, integrity, and adherence to evolving industry best practices.?

Role and Responsibilities:

• Lead Clinical Data Management:

• Oversee all aspects of clinical data management throughout the lifecycle of early- and late-phase oncology studies.

• Manage data governance and promote good clinical practices to enhance data quality and integrity.

• Guide the design, UAT, query resolution, and database closeout processes for eCRFs.

• Integrate expertise in EDC, RWE and external data to optimize data collection and standardization.

• Develop and implement proactive risk-based data management strategies, identifying critical data and utilizing efficient cleaning tools. Monitor and address KRIs for optimal data integrity.

• Unlock the power of data by combining visual storytelling with cutting-edge visualization tools. Simplify data review and uncover hidden trends and abnormalities with speed and accuracy.

• Drive Technical Leadership in Data Standards:

• Lead the development and implementation of clinical data standards, aligning with CDASH and SDTM standards, regulatory requirements, and industry best practices.

• Create robust data management and review plans, oversee data transfer agreements, and streamline processes for optimal data flow.

• Leverage emerging technologies and methodologies to optimize data standardization processes.

• Provide Strategic CRO and Vendor Oversight:

• Direct the evaluation and selection of CROs and vendors, ensuring adherence to company standards.

• Establish effective vendor partnerships and drive the selection of optimal data management technologies.

• Foster Cross-Functional Collaboration:

• Represent Data Management, building strong relationships with Clinical Operations, Clinical Science, Biostatistics, Statistical Programming, Regulatory and IT teams.

• Employ exceptional communication skills to align data management activities with broader clinical and business objectives.

• Champion Continuous Improvement and Innovation:

• Identify, implement, and champion best practices for data management, driving process standardization and efficiency gains.

• Ensure adherence to data security and governance principles, maintaining rigorous data integrity and compliance.

• Actively promote the exploration and integration of advanced technologies and methodologies.

• Introduce sound clinical data engineering practices to improve the process and outcome of clinical data collection and integration.

• Lead, Mentor, and Develop Talent:

• Provide leadership and mentorship to Data Management professionals and Clinical Programmers, fostering a culture of continuous learning and innovation.

• Directly manage the professional growth of team members, including Associate Directors and Sr. Managers.

• All other duties as assigned

Experience, Education and Specialized Knowledge and Skills:

• Bachelor's degree in Computer Science, Statistics, Life Sciences, or a related field is required. Master's degree in a relevant field is preferred.

• Minimum of 10+ years of progressive experience in clinical data management within the biopharmaceutical industry, including a demonstrated focus on oncology therapeutics.

• Proven leadership overseeing complex clinical data processes from acquisition to delivery, including leadership of data management teams.

• In-depth knowledge of Electronic Data Capture (EDC) systems and clinical databases. Experience with EHR, eCOA, IRT, and MDR systems is a plus.

• Proficiency in coding dictionaries (MedDRA, WHODRUG).

• Exceptional communication and collaboration skills, demonstrated through cross-functional leadership and effective conflict management.

• Documented success in fostering high-performance teams with a culture of innovation, continuous learning, and professional development.

• Experience in successful CRO and external vendor management.

• Demonstrated ability to identify and implement organization-wide standards, processes, and initiatives.

• Proven track record in managing global, cross-functional standards and processes.

• Entrepreneurial mindset with the ability to take measured risks, challenge the status quo, and drive change.

• Leadership experience influencing senior-level management and key stakeholders.

• Familiarity with common software and technologies used in clinical data science (e.g., SAS, R, Python, Rave, Veeva).

The pay range for this role is $200,000 - $240,000 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.

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