About Axcynsis Therapeutics

Axcynsis Therapeutics is a platform-based biotechnology company focusing on the development of Antibody-X Conjugate (AXC) therapies to revolutionise cancer treatments. Leveraging on proprietary technologies, we are developing a robust pipeline of AXC candidates with the potential to address unmet medical needs for new treatment options.

Roles and Responsibilities

• Lead and coordinate cross-functional teams to ensure timely and on-budget delivery of trial milestones.
• Prepare, review, and maintain essential clinical trial documents (Investigator Brochure, Protocol, ICFs, and Trial Master File).
• Manage the IRB/EC approval process across all trial sites.
• Lead clinical budget planning, contract negotiations, and financial oversight of CROs, vendors, and sites.
• Oversee selection, qualification, and ongoing performance of clinical vendors and investigative sites.
• Coordinate Investigational Product (IP) labeling, packaging, distribution, and ongoing supply logistics.
• Manage biological sample logistics, ensuring proper handling, shipment, and storage.
• Foster strong working relationships with clinical sites to support protocol compliance and patient recruitment.
• Serve as the central communication point for internal development teams, external partners, and KOLs.

Requirement of Qualifications, Skills and Experience

• PhD in life sciences or a related field;
• Minimum 2 years of clinical project management experience.
• Proven track record in managing early-phase (especially Phase 1) U.S.-based clinical trials.
• Prior experience in oncology trials is essential; ADC experience is a strong advantage.
• Strong vendor and site management capabilities.
• Solid understanding of FDA regulations, IND requirements, and ICH-GCP guidelines.
• Proficient with TMF systems, CTMS, and other relevant clinical trial platforms.
• Excellent leadership, interpersonal, and problem-solving skills.