Medical Director, Clinical Development

Alexion•Boston, MA

20h•Hybrid

About The Position

The Medical Director, Clinical Development may lead or support the clinical subteam and global program team in constructing global clinical development plans and contributing to asset-level and therapeutic-area strategies. The role is part of the Cell Therapy team and reports to the Senior Medical Director, Hematology. The position leads or supports the design and execution of multiple clinical studies or programs; represents Clinical Development on the Global Program Team and at management and review committees; and works with clinical study teams to prepare study-related documents. It also involves selecting advisory board participants and assessing disease and competitive-landscape information to support clinical development programs, asset plans, and therapeutic-area strategy. The role is primarily office-based, with an expectation of working in the office at least three days per week. The position offers eligibility for short-term incentive bonuses and equity-based awards, along with qualified retirement programs, paid time off, and health, dental, and vision coverage, subject to applicable plan terms.

Requirements

MD or international equivalent.
At least 3 years of clinical experience, preferably within industry.
Experience as a medical monitor for clinical trials.
Publication in peer-reviewed journals.

Nice To Haves

Board certification.
Knowledge of the assigned therapy area and ability to interpret, discuss, and represent trial- or program-level data.
At least 5 years of industry experience in clinical development.
Experience with medical responsibilities on a cross-functional team.
Basic statistical knowledge.
Understanding of general and specific therapeutic principles.
Experience designing industry-sponsored clinical trials.
Broad experience in clinical-trial methodology, statistics, data analysis, and interpretation.
Experience authoring study essential documents, Clinical Study Reports, and regulatory documents.

Responsibilities

Design and execute multiple clinical studies or clinical programs.
Represent Clinical Development on the Global Program Team and in presentations to management and review committees, including the Clinical Document Review Committee and Development and Commercial Steering Committee.
Work with clinical study teams to prepare clinical study documents, including protocols, charters, statistical summary reports, meeting presentations, publications, and clinical sections of regulatory documents.
Select appropriate advisory board participants and guide the team in preparing for meetings.
Critically evaluate information about relevant diseases and the competitive landscape, and synthesize it to support clinical development programs, asset plans, and therapeutic-area strategy.