Senior Clinical Program Manager/Clinical Program Manager (Early Development)

Scorpion Therapeutics is a precision oncology company founded in February 2020 by a preeminent group of scientists from Harvard University/Massachusetts General Hospital – Keith Flaherty, MD, Gaddy Getz, Ph.D. and Liron Bar-Peled, Ph.D. The company has raised $270M in Series A and Series B financings led by blue-chip investors, including Atlas Venture, Boxer Capital of Tavistock Group, EcoR1 Capital, LLC, Omega Funds, and Vida Venture.

Scorpion Therapeutics’ mission is to serve oncology patients by discovering and developing best-in-class and first-in-class, small molecule cancer medicines that address large patient segments with significant unmet medical needs. To accomplish this mission, we are building a highly collaborative team focused on the pursuit of novel approaches to small molecule drug discovery. This approach relies upon dynamic collaboration between cancer biology, proteomics, informatics, structural biology and medicinal chemistry – with the ultimate goal of realizing the full potential of targeted/precision oncology.

Job Summary:

The Sr. Clinical Program Manager/Clinical Program Manager will provide support and/or leadership to two or more Oncology studies and provide strategic planning and organization to ensure successful study completion. The Clinical Program Manager will maintain full ownership of the study and ensure the effective and efficient delivery of the operational aspects in accordance with the Clinical Plan, The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), Good Clinical Practice (GCP) standards, Scorpion Therapeutics Standard Operating Procedures (SOPs), local operating guidelines and local regulatory requirements.

Role Responsibilities/Accountabilities:

In this position, you will be primarily accountable for:

• Ensuringon time delivery of operational activities to meet the clinical study objectives
• Managing and overseeing Contract Research Organization (CRO) and other vendors
• Ensuring assigned vendor partners deliver on commitments to agreed targets
• Ensuring study adherence to budget, ICH-GCP standards, Scorpion Therapeutics SOPs and other operating guidelines and regulatory requirements
• Developing and cultivating productive relationships with internal and external partners/stakeholders
• Ensuring that risk and quality plans are robust and implemented for each assigned study
• Contributing to study management and clinical operations excellence by identifying opportunities, mitigating risks and supporting continuous improvement
• Driving and making clear decisions in the project team environment
• Contributing clinical operations expertise into the Clinical Development Plans

 In this position, you will be responsible to:

• Serve as a member of one or more global cross-functional study teams through all study stages (start-up, conduct, close-out) to contribute to the accomplishment of studies outlined by the Clinical Development Plan
• Oversee delegated outsourced activities to ensure Contract Research Organization (CRO) and vendor delivery
• Participate in developing and finalizing cross-functional activities to ensure delivery of critical clinical trial documents such as protocols, informed consent forms (ICFs), site and country budget templates, case report forms (CRFs), EDC systems , IRTS, central/specialty lab, ECG, imaging, drug supply and biomarker/sample management plans, TMF, and CSRs.
• Draft and implement study plans, including vendor oversight, risk, quality, safety, and communication
• Support EDC and Clinical Trial Management System (CTMS) systems and data maintenance
• Track timelines, milestones, budget, and critical study activities; identifying issues and proposing potential resolutions
• Partner closely with colleagues to provide strategic operational input on protocol feasibility
• Provide input into the study budget and manage assigned vendor budget(s); communicate variances in actual versus forecasted spend in vendor budgets and develop action plan for resolution
• Participate in selection of vendors (participate in the Request for Proposal [RFP] process)
• Utilize outputs from operational analytical tools to enhance and improve study execution
• Contribute to study site selection and management
• Oversee protocol, country, and site feasibility assessments
• Assist with all activities related to site selection, contracting, set-up and maintenance
• Develop site budget template and contribute to site budget negotiations in collaboration with CRO
• Proactively identify risks and develop risk mitigation strategies to ensure operational e