Associate Director (Supervisor) - Clinical Development
Scorpion Therapeutics, Indianapolis, Indiana, us, 46262
Role Summary
The Associate Director, Clinical Development is responsible for executing integrated clinical development plans and clinical trial packages aligned with the asset team. They lead the asset/indication clinical team, provide direction and technical expertise, and partner with senior leaders to model leadership behaviors and develop staff. Responsibilities
Clinical Planning: Develop the clinical plan from asset strategy through submission, inspection, approval, and post-launch support; collaborate to accelerate the complete trial package; lead global submission strategy. Clinical Execution: Coordinate with Clinical Design and CDTL for transition to execution; manage the global submission plan, communications, resources, and risks; oversee timelines and budget; manage risk plans and cross-functional communications; supervise partner expectations with CROs and alliances. Effective Management: Align cross-functional resources across therapeutic areas; ensure TMF and inspection readiness; model decision-making within compliance and quality requirements; drive continuous improvement of clinical development processes. People Management: Recruit, lead, develop, and retain a diverse workforce; foster inclusive culture; support talent identification and training for direct reports. Qualifications
Required: Bachelor's degree, preferably in a scientific or health-related field. Required: 5+ years' experience in the pharmaceutical industry and/or clinical development. Required: Legally authorized to work in the United States (visa sponsorship not anticipated). Preferred: Strong understanding of clinical development processes and interdependencies; demonstrated project management skills on complex/cross-functional projects; excellent communication and virtual team leadership skills; ability to coach and develop others; comfort working across geographies and cultures; PMP or similar certification; prior experience with CROs/alliances/JVs; prior submission and inspection experience; strong self-management and organizational skills; ability to influence without direct authority; travel may be required. Education
Bachelor's degree, preferably in a scientific or health-related field
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The Associate Director, Clinical Development is responsible for executing integrated clinical development plans and clinical trial packages aligned with the asset team. They lead the asset/indication clinical team, provide direction and technical expertise, and partner with senior leaders to model leadership behaviors and develop staff. Responsibilities
Clinical Planning: Develop the clinical plan from asset strategy through submission, inspection, approval, and post-launch support; collaborate to accelerate the complete trial package; lead global submission strategy. Clinical Execution: Coordinate with Clinical Design and CDTL for transition to execution; manage the global submission plan, communications, resources, and risks; oversee timelines and budget; manage risk plans and cross-functional communications; supervise partner expectations with CROs and alliances. Effective Management: Align cross-functional resources across therapeutic areas; ensure TMF and inspection readiness; model decision-making within compliance and quality requirements; drive continuous improvement of clinical development processes. People Management: Recruit, lead, develop, and retain a diverse workforce; foster inclusive culture; support talent identification and training for direct reports. Qualifications
Required: Bachelor's degree, preferably in a scientific or health-related field. Required: 5+ years' experience in the pharmaceutical industry and/or clinical development. Required: Legally authorized to work in the United States (visa sponsorship not anticipated). Preferred: Strong understanding of clinical development processes and interdependencies; demonstrated project management skills on complex/cross-functional projects; excellent communication and virtual team leadership skills; ability to coach and develop others; comfort working across geographies and cultures; PMP or similar certification; prior experience with CROs/alliances/JVs; prior submission and inspection experience; strong self-management and organizational skills; ability to influence without direct authority; travel may be required. Education
Bachelor's degree, preferably in a scientific or health-related field
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