Position Overview
We are seeking a highly motivated leader to join our dynamic research team focusing on the development of Antibody-X Conjugate (AXC) therapies to revolutionise cancer treatments. The successful candidate will play a pivotal role in overseeing the direction, planning and execution of our clinical development programs.
Key Responsibilities
- Provides expert medical and scientific guidance to strategically plan and execute IND filings and early-stage clinical trials.
- Performs medical oversight of clinical trials, drafts protocols and informed consent documents, and addresses queries from regulatory bodies, IRBs, and ethics committees. Reviews clinical data and ensures accuracy for final clinical study reports.
- Monitors safety throughout trials, ensures adherence to company standards and regulatory requirements (GCP/ICH), and supports development of investigator brochures.
- Leads the design, analysis, interpretation, and reporting of scientific content for protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions, and study-related documents.
- Supervises clinical research operations conducted by CRO partners.
- Maintains current knowledge of industry advancements and therapeutic areas through conferences, literature, and training.
- Collaborates closely with stakeholders to align product development plans and strategies strategically.
Qualifications:
- M.D. or equivalent with a minimum 3 years of experience is required
- Experience in clinical oncology will be preferred
- Demonstrated experience in global clinical trials, with specific experience in the US region
- Proven track record of effectively managing Phase 1 and/or 2 Oncology clinical trials.
- Strong organizational skills with meticulous attention to detail
- Excellent verbal and written communication skills
- Demonstrated leadership in leading cross-functional project teams
- Effective management and leadership skills
- Ability to work both independently and collaboratively within a dynamic biotech startup environment
