Medical Director, Clinical Development

Alexion•Boston, MA

5d•Hybrid

About The Position

The Medical Director, Clinical Development is part of the Cell Therapy team and reports to the Senior Medical Director, Hematology. The role 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 position is responsible for the design and execution of multiple clinical studies or programs and represents Clinical Development on the Global Program Team and at management and review committees. The role also works with clinical study teams on study-related documents, advisory board preparation, and evaluation of disease and competitive-landscape information to inform clinical development programs and strategies. Duties are generally conducted in an office environment. The role requires use of a computer; communication by phone, video, and electronic messaging; problem resolution; nonlinear thought, analysis, and dialogue; collaboration; and general availability during standard business hours. The position follows an in-office hybrid model, with an expectation of working in the office a minimum of three days per week, while respecting individual flexibility.

Requirements

MD; preferably a Hematologist.
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 the capability 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 at management and review committees, including the Clinical Document Review Committee and Development and Commercial Steering Committee.
Work with clinical study teams to prepare study-related 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 dissemination and incorporation into clinical development programs, asset plans, and therapeutic-area strategy.
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.