Job Summary
The Senior Director will oversee the clinical development initiatives for ALX2004. This role is pivotal in managing trial monitoring, crafting protocols, and performing data analysis. The individual will work closely with various teams, contract research organizations (CROs), and investigators to guarantee adherence to regulatory standards and the successful implementation of clinical programs.
Responsibilities
- Lead clinical development efforts for ALX2004, ensuring high-quality execution of clinical trials.
- Oversee and monitor clinical trials, ensuring they are conducted in compliance with regulatory requirements.
- Draft and develop clinical trial protocols to set clear objectives and methodologies.
- Analyze clinical data to derive insights and support decision-making.
- Collaborate effectively with cross-functional teams and external partners to achieve project goals.
Qualifications
- PhD or MD is required, complemented by a minimum of 10 years’ experience in oncology clinical development.
- Proven experience within the biotechnology or pharmaceutical sectors.
- In-depth understanding of FDA and EMA regulatory requirements, alongside GCP guidelines.
- Demonstrated expertise in medical monitoring practices.
