加入中美瑞康
共同打造创新型小核酸药物

Job Location: Shanghai, Suzhou

Report to: Chief Executive Officer

Position Overview:
The Director/VP of Business Development will lead business development activities at Ractigen Therapeutics, focusing on driving value through strategic partnerships and collaborations. This role involves crafting compelling business cases, executing deals, managing alliances, and collaborating effectively with internal teams and the CEO to support company objectives.

Key Responsibilities:

1. Strategic Contribution: Contribute insights on market trends, the competitive landscape, and emerging opportunities to support corporate direction and portfolio management.
2. Business Development Strategy and Execution: Develop and implement aligned BD strategies, leading the full deal process including identification, evaluation, due diligence, negotiation, and post-deal management for partnerships and licensing.
3. BD Pitch and Storyline Development: Craft compelling business pitches and develop high-impact BD materials tailored to effectively communicate Ractigen’s value proposition to diverse audiences.
4. Portfolio Management and Valuation Support: Support portfolio strategy by establishing asset valuation models, analyzing the competitive landscape, and collaborating with internal R&D and Finance teams.
5. Alliance Management and External Relations: Manage key alliances, represent Ractigen at external meetings and industry events, and stay current on relevant industry trends and scientific progress.
6. Internal Collaboration and Team Guidance: Foster strong collaborative relationships with key internal functions (R&D, Legal, Finance) and provide guidance to the BD team to ensure alignment and support activities.
7. Opportunity Assessment and Due Diligence: Conduct thorough assessments and rigorous due diligence of business opportunities, providing data-driven recommendations to senior management.

Qualifications:

• PhD in a biological or pharmaceutical-related field with over 8 years of business development experience in the biotech or pharmaceutical industry, including a proven track record of successful in-licensing/out-licensing deals.
• Experience in developing and executing business development strategies that contribute to company growth.
• Strong scientific acumen, analytical mindset, and deep familiarity with the drug discovery and development process.
• Proven ability to craft compelling business narratives and develop high-impact BD materials that resonate with stakeholders.
• Self-driven with strong problem-solving, collaboration skills, and a keen ability to identify and capitalize on business opportunities.
• Excellent organizational and time management skills, with the ability to interact effectively with potential partners, internal teams, and senior management.
• Exceptional English communication and presentation skills, with the ability to influence internal and external stakeholders.

Job Location: Suzhou

Report to: Executive Vice President, Product Development

Position Overview:

This position will be primarily responsible for the implementation and management of quality assurance policies implemented throughout all Ractigen facilities. This position will provide support to each department to increase standardization of processes, data collection, and training, while also being involved with the outsourced CMC process at CDMOs and CROs involved with the development, manufacturing and analysis of our API and drug products.

Responsibilities:

1. SOP & Process Management: Develop, implement, and maintain internal SOPs and quality processes; ensure alignment with experiments, define success/failure criteria, establish checklists, and drive continuous improvement.
2. Data Integrity & Records: Ensure data integrity via ELN review and audit trails; manage QA documentation (findings, training, changes), records, SharePoint, and project tracking tools.
3. Training & Quality Culture: Develop and deliver QA training programs, perform gap analyses on protocol adherence, measure quality standards, and actively promote a robust quality culture.
4. Equipment Oversight: Oversee calibration, maintenance, and repair records for laboratory equipment.
5. Outsourced Quality Oversight: Oversee quality aspects of outsourced CMC processes, development activities, and tech transfers, collaborating closely with internal teams (Pre-clinical, Translational, Chemistry).
6. External Partner & Vendor Management: Manage external partner/vendor compliance, perform gap analyses on external data (vs. FDA/NMPA), develop metrics, manage concerns, and assess supply chain risks.
7. Regulatory Compliance: Manage regulatory compliance activities including reporting, technical reviews, assessments (deviations, CAPAs, changes), and responses to regulatory inquiries related to API manufacturing.
8. Audits & Certifications: Coordinate and lead preparations for regulatory inspections, audits, and certifications (e.g., P2 lab), including required documentation.
9. Strategic Quality Input: Develop strategies for early problem resolution and product lifecycle quality; provide input on process/equipment improvements, potential in-sourcing, and facility development (e.g., GLP).

Qualifications:

• Relevant degree (Chemistry, Biochemistry, Pharm Sci; Advanced desirable) with 5+ years in pharmaceutical development (min. 3+ QA); oligonucleotide experience a plus.
• Knowledge of global regulatory frameworks (FDA/NMPA), QA policies, root cause analysis, and their practical application in drug development workflows.
• Proven experience working effectively with CROs, CDMOs, and other development vendors.
• Excellent verbal and written communication skills; detail-oriented and articulate.
• Works effectively independently and collaboratively; resilient and flexible in high-stress, multi-disciplinary environments.
• Strong organizational, prioritization, and time-management skills across multiple projects; project management experience is a plus.
• Proficient with MS Office tools for project management, tracking, writing, and presentations.

工作地点: 江苏 苏州

汇报对象: 临床前VP

岗位职责：

1. 负责领导和执行IND项目的毒性研究，制定和执行高质量、及时、综合和科学合理的IND申报毒理策略；
2. 制定和管理IND项目的药物毒理研究预算和时间表；
3. 建立里程碑，时间表，工作流程，确保项目里程碑和主要目标的实现；
4. 分析毒理学数据以确定FIH剂量和计划，制定/执行PK、药物代谢、药效学等分析计划；
5. CDMO /CRO的选择、审核和管理，包括获取GLP和非GLP研究的报价/成本估算，解决合同工作中可能出现的问题，协调多个承包商等。
6. 起草和修改毒理学研究相关文件和法规文件，如IND应用的CTD, IBs等；
7. 与监管机构就药物或IND前/IND工艺的其他方面进行沟通和互动；
8. 与其他职能部门密切合作，如DMPK，生物学，CMC和临床开发；
9. 上级安排的其他任务，指导内部药物毒性研究等。

任职要求:

1. 药理学或毒理学博士学位，5年以上相关工作经验；
2. 至少2次成功的IND申报记录；对药物开发过程有深入的了解，特别是毒性，药理学方面。熟悉FDA/NMPA IND申报的法规政策，如ICH指南等；
3. 优秀的领导、决策和判断能力，良好的管理和沟通能力；
4. 有成熟药企工作经验者优先；有小型核酸药物开发经验者优先；
5. 优秀的英语写作和口语表达能力。