Role Summary
Associate Director/Director, Clinical Delivery Capabilities - EMP at Lilly. Provide operational leadership to support exploratory and biopharmaceutics clinical development, collaborating across functions to deliver knowledge, templates, and technology to enable portfolio delivery and continuous improvement.
Responsibilities
- Establish networks with key support areas to efficiently support exploratory and biopharmaceutics clinical studies, including updates to corporate systems and documentation management.
- Provide leadership in interactions with partners, manage issue escalation and relationship management, and assess vendors and clinical research units as appropriate.
- Maintain awareness of regulatory issues and trends relevant to the portfolio.
- Lead cross-functional business processes supporting early phase development and develop expertise on key systems supporting development.
- Review procedures across subject areas, contribute to strategic direction of cross-functional systems and processes.
- Apply deep development knowledge to review processes and sponsor improvement initiatives to increase efficiency and value; ensure internal and external process alignment.
- Act as a resource to governance committees regarding processes used in development; ensure networks with Quality, Clinical Information and Process Automation, and L&D are established to meet Quality and Regulatory requirements.
- Define metrics to quantify portfolio deliverables and assess process effectiveness; develop and implement a metrics/evaluation strategy (e.g., scorecards).
- Identify and develop emerging technologies to support advancement of medicines to the clinic (e.g., AI tools); monitor implementation progress and recommend corrective actions.
- Attract, retain, and develop a diverse workforce; model behaviors and foster an environment focused on performance, learning, and development; recognize and reward teams and individuals.
- Coach and mentor department and cross-functional personnel to support development and growth.
Qualifications
- BachelorβΓΓ΄s degree in a science-related field; 3+ years in pharmaceutical industry with direct experience managing clinical studies.
- Experience with regulations and guidelines governing clinical trials; strong project management and leadership skills; ability to work cross-culturally and virtually.
- Advanced degree (PharmD or similar) preferred; 5+ years in pharmaceutical industry with direct experience managing clinical studies, ideally in exploratory/biopharmaceutics.
- Ability to travel up to 10% (varies by responsibilities).