4 часа назад
Clinical Research Physician (Clinical Development)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Clinical Research Physician (Clinical Development): Leading clinical development strategy and trial execution for AbbVie therapeutic areas in China with an accent on protocol design, regulatory pathways, safety oversight, and scientific partnerships. Focus on evaluating trial opportunities, shaping registration strategies, supporting clinical studies, and translating efficacy and safety data into regulatory and development recommendations.
Location: North Chicago, Illinois, United States; Conditions: Shanghai, China
Company
develops innovative medicines and solutions across areas including immunology, oncology, neuroscience, and aesthetics.
What you will do
- Propose clinical development strategies and pathways for registering new compounds in China.
- Lead China local development projects and assess trial opportunities, diseases, compounds, alliances, and partnerships.
- Provide China-specific input on clinical development plans, protocols, and global target product profiles.
- Work with Regulatory Affairs to prepare clinical filing materials from CTA through NDA approval.
- Support trial medical monitoring, site questions, data queries, and efficacy and safety analysis.
- Establish partnerships with Chinese academia and study centers and provide medical training to investigators and clinical operations teams.
Requirements
- Medical degree and strong medical background in a relevant therapeutic area.
- At least 3 years of experience in medical or clinical development at a pharmaceutical or biopharmaceutical company, or equivalent clinical practice.
- Knowledge of clinical study design, data collection, management, analysis, and interpretation.
- Understanding of the interaction between Regulatory Affairs, Clinical Development, and Commercial objectives.
- Strong scientific communication, collaboration, analytical, and recommendation-development skills.
- Fluent spoken English and solid written English are required.
Nice to have
- Experience leading multiple, diverse clinical development programs.
Culture & Benefits
- Work in a patient-centric environment focused on scientific quality and integrity.
- Collaborate with global, JAPAC, China affiliate, regulatory, medical, commercial, and academic stakeholders.
- Operate in compliance with applicable laws, regulations, codes of conduct, and company policies.
- Equal opportunity employment with a commitment to integrity, innovation, and community service.
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