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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.

This position is responsible for toxicity studies of company’s preclinical drug programs for IND application of FDA and NMPA. Responsibilities include but are not limited to making and executing toxicity study plans, coordinating CMO and CRO activities, setting timelines and milestones to ensure timely execution of toxicity plan for IND programs.

Job Location: Suzhou city, Jiangsu Province, China

Report to: This position reports directly to VP, Translational Development.

Responsibilities

• Plan, lead, and execute toxicity study for IND projects. Developing and executing high quality, timely, integrated and scientifically sound toxicity strategies for IND submission.
• Develop and manage a PharmTox budget and timeline for IND projects.
• Establish milestones, timelines, workflows and make sure projects’ milestones and major objectives are met.
• Analyze the toxicity data to determine FIH dose and schedule, development/execution of plans to analyze PK, drug metabolism, pharmacodynamics, etc.
• CMO/CRO selection, audit, and management including acquiring quotes/cost estimates for GLP and non-GLP studies, resolving issues that may rise during contracted work, coordination between multiple contractors, etc.
• Draft and modify toxicology study-related and regulatory documents such as CTD for IND applications, IBs, etc.
• Communicate and interact with regulatory agencies regard to pharmtox or other aspects of the Pre-IND/IND process
• Work close with other functions such as DMPK, biology, CMC and clinical development.
• Ad hoc assignments by supervisors. Guide in-house pharmtox studies.

Requirements

• PhD degree in pharmacology or toxicology with more than 5 years of relevant working experiences.
• Track record of at least 2 successful IND filings.
• Deep knowledge about drug development process especially in toxicity, pharmacology. Quite familiar with regulatory policies e.g., ICH guidelines et al, for IND filing of FDA/NMPA.
• Excellent leadership, decision-making and judgment skills, good management and communication skills.
• Working experiences in big pharma companies is preferred.
• Experience in small nucleic acid drug development is a plus.
• Excellent skill in English writing and oral communication.