Executive Medical Director, Hematology Clinical Development

Alexion Pharmaceuticals, Inc.; Boston (MA); Hybrid; USD 332,000 - 498,000; Full time

Job summary

Alexion Pharmaceuticals, Inc. seeks an Executive Medical Director (EMD) to oversee multiple clinical development programs, mentor Medical Directors and CDS, and provide expert input on regulatory and strategic decisions across programs from IND/CTA through Phase 2/3 and beyond.

The role involves leading cross-functional teams, contributing to regulatory strategy, and representing Clinical Development in internal and external forums.

Qualifications

• MD or equivalent medical degree required.
• 7+ years in clinical development and regulatory exposure.
• Experience with multinational trials and regulatory meetings (FDA)
• Ability to lead cross-functional teams to define clinical strategy and study design
• Experience supporting business development activities is a plus
• MD with clinical training preferred; PhD desirable but not required

Responsibilities

• Lead 2 program teams and drive successful execution of clinical studies and strategies.
• Represent Clinical Development on Global Program Team and Global Medicine Team in management presentations.
• Foster development of Medical Directors and CDS; oversee two programs and related clinical documents.
• Provide scientific and medical input to other R&D, regulatory, and business development functions.
• Represent Alexion Clinical Development to internal management and external academic/regulatory communities.
• Oversee writing of clinical sections of CTD, white papers, and regulatory responses.
• Coordinate cross-functional planning with Global Medical Affairs, Safety, Biostatistics, and Clinical Operations.

Skills

Medical leadership

Clinical development

Regulatory input

Cross-functional leadership

Mentoring

IND/CTA knowledge

Education

MD or equivalent

PhD desirable

Job description

Alexion Pharmaceuticals, Inc. seeks an Executive Medical Director (EMD) to oversee multiple clinical development programs, mentor Medical Directors and CDS, and provide expert input on regulatory and strategic decisions across programs from IND/CTA through Phase 2/3 and beyond.

The role involves leading cross-functional teams, contributing to regulatory strategy, and representing Clinical Development in internal and external forums.