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Job Summary: **
The Clinical Development Trial Lead at Lilly Suzhou Pharmaceutical Co., Ltd. is responsible for the overall execution, management, and oversight of assigned clinical trials within the designated therapeutic area, ensuring adherence to regulatory requirements, Good Clinical Practice (GCP), and company standard operating procedures. This role involves leading cross-functional teams to deliver high-quality clinical trial data on time and within budget.
Job Responsibilities: **
- Lead the planning, initiation, execution, and close-out activities for assigned clinical trials, working closely with internal and external stakeholders.
- Develop and manage trial budgets, timelines, and resources, ensuring efficient and effective trial progress.
- Oversee the selection, qualification, and management of contract research organizations (CROs) and other external vendors, ensuring their performance meets trial objectives and quality standards.
- Ensure adherence to all applicable regulatory requirements (e.g., FDA, NMPA), ICH GCP guidelines, and Lilly SOPs throughout the trial lifecycle.
- Manage trial-related documentation, including protocols, informed consent forms, monitoring plans, and clinical study reports.
- Facilitate effective communication and collaboration within the clinical trial team, including clinical scientists, medical monitors, biostatisticians, data managers, and regulatory affairs personnel.
- Monitor trial progress, identify potential risks, and implement mitigation strategies to ensure successful trial completion.
- Participate in the development and review of clinical study reports, publications, and presentations.
- Contribute to the continuous improvement of clinical trial processes and operational excellence.
- May involve direct supervision or mentorship of junior clinical trial staff.
Job Qualifications: **
- Bachelor's degree in a life science or related field (e.g., Biology, Pharmacy, Nursing). Advanced degree (Master's, Ph.D., PharmD) preferred.
- Minimum of 7 years of experience in clinical research, with at least 3 years in a clinical trial leadership or project management role within a pharmaceutical company or CRO.
- In-depth knowledge of global regulatory requirements for clinical trials (e.g., ICH GCP, NMPA regulations, FDA regulations).
- Demonstrated experience in managing complex clinical trials from initiation to close-out across different phases (Phase I-IV & Real world study).
- Strong leadership, communication, and interpersonal skills with the ability to influence and collaborate effectively with diverse teams.
- Proven ability to manage budgets, timelines, and resources effectively.
- Excellent problem-solving and decision-making abilities.
- Proficiency in English (written and spoken) is essential.
- Ability to travel domestically and internationally as required.
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
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