Role/Function Summary:
Clinical lead in therapeutic area of CNS or cardiovascular diseases
Clinical lead in compound development team
Responsibilities and Duties:
1. Work with compound team to formulate compound development strategy and clinical development plans with profound knowledge in certain therapeutic areas.
2. Take responsibility for the design of clinical studies. Oversee protocol writing, medical reviews, data interpretation, and CSR delivery. Take a leadership role in the clinical study team to ensure high-quality execution from a medical perspective.
3. Contribute to regulatory materials and other documents related to clinical activities.
4. Provide medical support for the evaluation of introduced projects and the establishment of new projects of the company.
5. Help with tracking of new progression in related therapeutic area and maintain connection with experts in fields.
6. Buide-up and maintain connections with KOLs in specific areas.
Educational Requirements:
The preference is for candidates with a doctor’s degree, with a background in CNS or cardiology.
Experience:
1. Industry experience for 8+ years
2. Rich hand-on experience as study physician. Experience of clinical lead is preferred.
3. Familiar with GCP/ICH requirement and guidelines.
4. Familiar with clinical study execution.
5. Familiar with both domestic and international regulatory processes, possessing the capability to draft and review application documents.
Other Skills and Abilities:
1. Strong English reading and writing skills, capable of international communication.
2. Excellent communication, organization, coordination, and problem-solving skills.
3. Strong learning capability.