创新药企（IPO后期）
CRPD
生命科学
生命科学
北京
10年以上
博士
¥60 - 90K15薪
公司介绍
专注在心血管系统疾病，中美双报研究，新品预期2027年上市，目前开展III期研究阶段。
职位描述
1. Clinical Strategy & Trial Design:
o Lead the US medical strategy and contribute significantly to the global clinical development plans for cardiovascular programs.
o Provide expert input into the design of clinical trial protocols, including study endpoints, patient population, and safety monitoring plans, ensuring scientific rigor and alignment with US FDA and ICH/GCP standards.
o Drive the development of key clinical documents (protocols, IBs, CSRs, regulatory submissions).
2. Trial Execution & Medical Oversight:
o Serve as the primary medical monitor for US-based trials, providing medical guidance to the clinical operations team.
o Review and interpret clinical data, including safety and efficacy outcomes, in collaboration with data management and biostatistics.
o Address medical queries from sites and serve as the key point of medical contact for investigators and internal teams.
3. Regulatory Engagement & Submissions:
o Represent the company in interactions with the US FDA and other health authorities.
o Contribute to the preparation and review of US regulatory submissions, focusing on the clinical sections.
o Participate in and prepare for FDA meetings (e.g., Type B, End-of-Phase II).
4. KOL Engagement & Scientific Leadership:
o Establish and maintain strong relationships with US-based KOLs, clinical trial investigators, and academic institutions in cardiology.
o Provide scientific and medical expertise to support business development, licensing, and partnership evaluations as needed.
o Represent the company at major scientific congresses and contribute to publications.
5. Global Cross-functional Collaboration:
o Work seamlessly with the China-based CMO and global development team (Clinical Operations, Biometrics, Regulatory, Safety, etc.) to ensure aligned strategy and flawless execution.
o Effectively manage cross-cultural and cross-time-zone collaboration within the global R&D organization.
职位要求
1. Education:
o Medical Doctor (M.D.) degree required. Board certification or equivalent in Cardiology, Cardiovascular Diseases, or Internal Medicine is highly preferred.
o Active or historical US medical license is a strong plus.
2. Experience:
o Minimum of 8+ years of relevant clinical development experience within the US biopharmaceutical or CRO industry. o Proven track record of significant contributions to the design and execution of late-phase (Phase II/III) clinical trials; experience with MRCTs is a significant advantage.
o Prior experience with IND/NDA submissions is desirable.
o Strong understanding of US regulatory landscape, ICH/GCP, and cardiovascular drug development.
3. Skills & Competencies:
o Excellent scientific acumen and strategic thinking with the ability to translate science into viable clinical development plans.
o Outstanding communication and presentation skills, with the ability to engage effectively with internal teams, external experts, and regulatory agencies.
o Proven ability to work independently and drive projects in a dynamic, fast-paced, cross-cultural environment.
o Fluency in English (written and spoken) is required. Proficiency in Mandarin Chinese is a significant advantage for effective collaboration with headquarters.
4. Personal Attributes:
o Entrepreneurial spirit, self-motivated, and comfortable in a high-growth, collaborative company setting.
o Results-driven with a strong sense of accountability and integrity.
咨询顾问
分享