Senior Medical Director (United States)

Our Client

Our client is a leading biotech company headquartered in US. They typically engage in research, development, and commercialization of products and technologies related to healthcare and life sciences. They also leverage on biology, chemistry, genetics, and other scientific disciplines to create innovative solutions for healthcare and life sciences industries. Right now, they are looking for a Senior Medical Director (based in United States) and this person will provide strategic oversight for the direction, planning, execution, and interpretation of clinical trials or research activities within a clinical development program.

Job Description

• Lead the design and implementation of clinical development programs based on robust medical and scientific principles.
• Provide project-related education to investigators, study site personnel, and internal study staff. Oversight may extend from early development to phase 3 studies for internal and/or partnered programs.
• Assume overall responsibility for the oversight of clinical studies, ensuring study integrity, reviewing, interpreting, and communicating accumulating data on safety and efficacy.
• Collaborate with Clinical Operations for study enrollment oversight and adherence to overall timelines for key deliverables.
• Assess and report serious adverse events per corporate policy and regulations.
• Oversee the work of other Medical Directors and Clinical Scientists involved in the same or related study/programs.
• Provide in-house clinical expertise for compounds and indications, coordinating scientific and medical activities with internal stakeholders related to ongoing clinical study/projects.

Requirements

• Master degree in health sciences or relevant professional qualifications 
• Minimum 15 years of relevant experience at Director level and 5 years of relevant experience at Senior Director level in medical monitoring of Oncology clinical trials, with relevant clinical development/pharma experience considered. Experience with Biologicals (ADCs and Immune Oncology preferred).
• Track record of successful management of product safety in phase 1 and/or 2 Oncology clinical trials (phase 3 experience considered).
• Experience in the clinical and drug development process in a global pharmaceutical/biotechnology company, including preparation of risk management plans, aggregate reports, and company core safety information.
• Advanced analytical, leadership, decision-making, and communication skills.
• Willing to travel at least 30% of the time across EMEA and APAC.