Associate Director, Clinical Data Management

Non-small Cell Lung Cancer (NSCLC)

• HARMONi: Phase 3 clinical study which was intended to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who were previously treated with a 3rd generation EGFR TKI.
• HARMONi-3: Phase 3 clinical study which is intended to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic NSCLC.
• HARMONi-7: Phase 3 clinical study which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC.

Colorectal Cancer (CRC)

• HARMONi-GI3: Phase 3 clinical study intended to evaluate ivonescimab in combination with chemotherapy compared with bevacizumab plus chemotherapy.

Ivonescimab is an investigational therapy not presently approved by any regulatory authority other than China's National Medical Products Administration (NMPA). Summit is headquartered in Miami, Florida, and has additional offices in California, New Jersey, the UK, and Ireland.

Overview of Role

We are looking for an experienced Associate Director, Clinical Data Management that will contribute to and support the company's research and development efforts to create high value therapeutics to address unmet medical needs. The Associate Director, Clinical Data Management independently leads the data management components of a clinical trial ranging from small early phase to large global and late phase programs.

This role will direct the planning, implementation and overall direction of executing/achieving clinical trial data management activities including CRF/eCRF design, database development, validation programming, data review, discrepancy management, and database lock.

Additionally, the position will manage data management staff, Contract Research Organizations (CROs) and service providers' activities in overseeing the data management process life cycle in coordination with internal Biostatistics, Clinical, and Regulatory teams to ensure the accurate, efficient, and complete data collection for clinical trials.

Role and Responsibilities

• Provide expertise and contribute to the strategy and development of the Clinical Data Management Portfolios to ensure data quality in support of clinical study data milestones and deliverables
• Lead and support establishment of systems and processes to help ensure clinical data security, integrity, and long-term goals of the business function, in alignment with company priorities
• Leads the data management of overall drug development process with early and late phase clinical trials in large or complex development program(s)
• Provides technical expertise to develop and implement clinical data standards, data management plans, data transfer agreements, and data flow processes to ensure timely and quality data delivery for analysis purpose
• Oversees the process to identify, evaluate and select CROs, vendors and technology for CDM activities
• Leads, designs and/or oversees eCRF design, eCRF specifications, eCRF completion guidelines, annotated CRFs, User Acceptance Testing, query logic, edit checks, data query resolution, SAE reconciliation between clinical and pharmacovigilance databases, vendor data reconciliation & cleaning, data migration and database closeout for clinical trials
• Represents Data Management and promotes productive collaboration with other functions (e.g., Clinical Operations, Clinical Development, Biostatistics, Statistical Programming, Translational Science, Project Management, Regulatory, QA, and IT) to ensure proper alignment around data management activities & deliverables, operational excellence, compliance with regulations, policies, procedures, and clinical objectives
• Supports cross functional teams and studies to handle data management questions, troubleshoot, help resolve issues and mitigate risks. Initiates continuous efforts in reviewing and identifying best practices among study teams and enforcing standardization among teams and studies
• Works with the Director of Clinical Data Science (CDS) to enhance efficiency, optimize costs, and drive excellence
• Works with the Director of Clinical Data Science to establish CDM processes and procedures including SOPs to ensure highest data quality/integrity/security and regulatory. compliance with FDA regulations, GCP, ICH guidelines and Good Clinical DM Practices.
• Leads clinical data management activities during regulatory audits, ensuring compliance with industry standards and regulations, and providing expert input throughout the audit process
• Works with the Head of Statistical Programming & CDS to manage departmental budget and execute resource planning across multiple projects
• Works with the Director of Clinical Data Science to provide oversight and guidance, as well as establish key performance metrics with CROs to ensure the highest data quality/integrity and regulatory compliance
• Accommodate ad hoc data requests between clinical team members, scientists, and vendors to support data cleaning, data entry requirements and exploratory data review if needed
• Uses scientific and drug development knowledge to anticipate and mitigate data management-related challenges during clinical trial execution
• Reviews and contributes to clinical protocols and amendments, study manuals, and other study conduct related clinical documents; review clinical data according to these documents
• All other duties as assigned

Experience, Education and Specialized Knowledge and Skills

• Bachelor's degree in Life Sciences, Computer Science, or relevant field of study; or equivalent practical experience
• A minimum of 10+ years of Clinical Data Management experience (oncology experience highly desirable) in biotechnology or pharmaceutical industry with excellent understanding of late phase clinical drug development processes required
• Experience with various data collection and Electronic Data Capture (EDC) systems and understanding of the MedDRA and WHODRUG coding processes
• Strong track record of line management and supervisory experience of CDM staff, shown leadership skills to lead and inspire CDM staff including consultants
• Excellent interpersonal, communication, and leadership skills
• Consistent, detail oriented, communicative, dedicated to do a job well done
• CRO and vendor oversight experience preferred
• Strong knowledge of clinical research, FDA & ICH, GCP, GCDMP, and related regulatory requirements

This is the pay for this position

Pay Transparency $174,000—$205,000 USD

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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