Executive Leader, Hematology Clinical Development

Alexion; Boston (MA); On-site; USD 280,000 - 360,000; Full time

Job summary

Alexion in Boston is seeking an Executive Medical Director to oversee 2+ clinical development programs in hematology. The role involves mentoring Medical Directors and CDS, guiding regulatory strategy, and contributing strategically to cross-asset teams.

The EMD will supervise medical monitors, participate in global governance, and drive clinical development plans, CTD writing, and due diligence for business development. Strong leadership and regulatory experience required.

Qualifications

• MD or equivalent in Hematology.
• 7+ years of experience in clinical development.
• Experience preparing regulatory documents and attending FDA/regulatory meetings.
• Experience designing multinational clinical trials.
• Demonstrated ability to lead cross-functional teams.
• Experience supporting business development activities.
• MD or equivalent, preferably with clinical training.
• PhD in related discipline desirable, but not required.

Responsibilities

• Lead 2+ program teams and drive execution of clinical studies and development strategies.
• Represent Clinical Development on Global Program Team and Global Medicine Team in management reviews.
• Lead and oversee clinical development strategy documents including protocols, charters, and regulatory sections.
• Provide scientific input to R&D, regulatory, and business development functions.
• Represent Alexion Clinical Development to internal and external communities.
• Oversee writing of clinical sections of CTD, white papers and regulatory responses.
• Coordinate with cross-functional teams to align program strategy and study design.

Skills

MD or equivalent in Hematology

Clinical development leadership

Regulatory meetings with FDA

Multinational trials design

Cross-functional leadership

Business development support

Education

MD or equivalent

PhD desirable

Job description

Alexion in Boston is seeking an Executive Medical Director to oversee 2+ clinical development programs in hematology. The role involves mentoring Medical Directors and CDS, guiding regulatory strategy, and contributing strategically to cross-asset teams.

The EMD will supervise medical monitors, participate in global governance, and drive clinical development plans, CTD writing, and due diligence for business development. Strong leadership and regulatory experience required.