Director Medical Study Operations
Scorpion Therapeutics, Sleepy Hollow Trailer Village, Arizona, United States
Role Summary
The Director, Medical Study Operations will oversee External Sponsored Research (ESR) programs including Investigator-Initiated Studies (IIS) and Research Collaboration (RC). Responsibilities include people management, establishing structure and procedures to support growth, ensuring timely deliverables, and providing financial management support. The role involves leading cross-functional activities to ensure compliant, efficient management of ESR programs across multiple products or therapeutic areas. Responsibilities
Support of Investigational and/or Commercialized Products, including non-filing post-marketing research activities, timelines, key deliverables, budgets, forecasting, disclosures, and compliance Support of Late-Stage Molecules, and launch readiness activities Support of Early Phases molecules, post-IND filing, ensure non-clinical and non-drug studies are reviewed in line with brand and corporate strategy, and ensuring no conflicts with ongoing development plans Alliance (collaboration partner) Management: Ensuring optimal alignment with both Alliance and internal collaborators for processes and strategy supporting a therapeutic area or multiple products; drive activities forward while communicating risks and solutions transparently Ensure ESR programs are led compliantly, with cross-functional reviews and inputs completed, and senior input as needed prior to implementing Program management: budgets, timelines, publications, risk management, compliance; oversee all aspects of program planning in support of multiple products or a therapeutic area, including lifecycle management, budget allocation/movement, timelines and deliverables, risk mitigation planning, and annual review of Areas of Interest in alignment with corporate strategy Budget tracking, planning, reporting: oversee budgeting aspects including annual planning, projections for activities/programs, drug-related costs, reforecasts, actuals and accruals; oversee budget reporting for program planning, corporate audit, sunshine act, and commercial finance Drug/material planning, shipping, tracking, expiry, temp excursions, quarantines: oversee drug/material planning including timing of drug and labeling campaigns, expiry events and potential impact, ensuring compliance for shipments, temp excursions, and quarantines Compliance: ESR Processes, FMV, Safety, Regulatory, Training; adhere to and ensure team adherence to SOPs and required reporting; create/update SOPs, practices, forms and tracking documents; ensure audit readiness Recruit and develop direct reports with growth-minded goals and development plans Qualifications
Required: Bachelor’s degree or advanced degree or equivalent work experience; 16+ years of progressive industry/relevant professional experience; mandatory Biotech/Pharmaceutical experience; 11+ years of active work experience in clinical research and/or regulatory and/or field-based roles in pharmaceutical and/or biotech companies; proven ability to work in a fast-paced, dynamic environment, with minimal supervision and effective collaboration with clinical, pre-clinical, commercial, and external partners
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The Director, Medical Study Operations will oversee External Sponsored Research (ESR) programs including Investigator-Initiated Studies (IIS) and Research Collaboration (RC). Responsibilities include people management, establishing structure and procedures to support growth, ensuring timely deliverables, and providing financial management support. The role involves leading cross-functional activities to ensure compliant, efficient management of ESR programs across multiple products or therapeutic areas. Responsibilities
Support of Investigational and/or Commercialized Products, including non-filing post-marketing research activities, timelines, key deliverables, budgets, forecasting, disclosures, and compliance Support of Late-Stage Molecules, and launch readiness activities Support of Early Phases molecules, post-IND filing, ensure non-clinical and non-drug studies are reviewed in line with brand and corporate strategy, and ensuring no conflicts with ongoing development plans Alliance (collaboration partner) Management: Ensuring optimal alignment with both Alliance and internal collaborators for processes and strategy supporting a therapeutic area or multiple products; drive activities forward while communicating risks and solutions transparently Ensure ESR programs are led compliantly, with cross-functional reviews and inputs completed, and senior input as needed prior to implementing Program management: budgets, timelines, publications, risk management, compliance; oversee all aspects of program planning in support of multiple products or a therapeutic area, including lifecycle management, budget allocation/movement, timelines and deliverables, risk mitigation planning, and annual review of Areas of Interest in alignment with corporate strategy Budget tracking, planning, reporting: oversee budgeting aspects including annual planning, projections for activities/programs, drug-related costs, reforecasts, actuals and accruals; oversee budget reporting for program planning, corporate audit, sunshine act, and commercial finance Drug/material planning, shipping, tracking, expiry, temp excursions, quarantines: oversee drug/material planning including timing of drug and labeling campaigns, expiry events and potential impact, ensuring compliance for shipments, temp excursions, and quarantines Compliance: ESR Processes, FMV, Safety, Regulatory, Training; adhere to and ensure team adherence to SOPs and required reporting; create/update SOPs, practices, forms and tracking documents; ensure audit readiness Recruit and develop direct reports with growth-minded goals and development plans Qualifications
Required: Bachelor’s degree or advanced degree or equivalent work experience; 16+ years of progressive industry/relevant professional experience; mandatory Biotech/Pharmaceutical experience; 11+ years of active work experience in clinical research and/or regulatory and/or field-based roles in pharmaceutical and/or biotech companies; proven ability to work in a fast-paced, dynamic environment, with minimal supervision and effective collaboration with clinical, pre-clinical, commercial, and external partners
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