Global Chief Medical Officer
Мэтч & Сопровод
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Описание вакансии
TL;DR
Global Chief Medical Officer (Clinical Development): Lead global clinical development strategy and execution for cell therapy programs with an accent on Phase I–IV trial design, regulatory compliance, and cross-geography clinical operations across the US and China. Focus on ensuring safety, efficacy, and high-quality data review while guiding IND/CTA submissions and driving clinical decision-making from pre-clinical through post-market activities.
Location: Somerset, New Jersey, United States
Salary: $434,828 - $570,710 USD (base pay)
Company
is a global biotechnology company developing advanced cell therapies for life-threatening diseases.
What you will do
- Own global clinical development strategy and oversee execution across the pipeline, aligning clinical plans with corporate goals and scientific advancements.
- Lead clinical trial design, conduct, and interpretation for cell therapy products across Phase I–IV, ensuring rigor in scientific, regulatory, and clinical outcomes.
- Build and lead cross-functional clinical development teams across geographies (US and China), including medical, scientific, pharmacovigilance, clinical operations, site management, biometrics, and data integrity.
- Drive regulatory interactions and compliance with FDA, EMA, and NMPA requirements, including leadership for IND/CTA and other regulatory submissions.
- Oversee clinical operations delivery on time and within budget, including safety monitoring, adverse event reporting, and risk management.
- Provide clinical thought leadership for cell and gene therapy, support commercialization and investor communications, and guide clinical input for business development.
Requirements
- MD or MD/PhD with specialization in oncology, immunology, hematology, or a related field; additional training in clinical pharmacology, cell and gene therapy, or molecular biology is highly desirable.
- 15+ years of experience in clinical development, with a significant portion in cell and gene therapy or advanced biologics; proven leadership from Phase I through commercialization.
- Deep knowledge of clinical trial design, regulatory requirements, and GxP compliance (FDA, EMA, NMPA), including strong global regulatory experience with INDs and clinical trial applications.
- Direct leadership experience establishing and leading complex global clinical operations, including cross-border teams and clinical development in China.
- Demonstrated ability to develop and manage global development budgets and deliver quality outcomes on time and within budget.
- Fluency in English; proficiency in Mandarin is a plus.
Culture & Benefits
- Hybrid work model.
- Medical, dental, and vision insurance plus a 401(k) retirement plan with company match.
- Eight weeks of paid parental leave after three months of employment and paid time off including vacation, personal time, sick time, floating holidays, and 11 company holidays.
- Flexible spending and health savings accounts, life and AD&D insurance, disability coverage, and additional supplemental plans.
- Performance-based bonus and/or equity available for eligible roles.
Hiring process
- Interviews focused on clinical development leadership, regulatory strategy, and experience with global cell therapy programs.
- Discussions with stakeholders on cross-functional and cross-border team leadership and clinical trial execution.
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