Medical Director, Clinical Development

AstraZeneca•Boston, MA

1d•$249,827 - $374,741•Hybrid

About The Position

The Medical Director, Clinical Development is part of the Cell Therapy team and may lead or support the clinical subteam and global program team in constructing global clinical development plans. The role also contributes to asset-level and therapeutic-area strategies and reports to the Senior Medical Director, Hematology. The position is generally conducted in an office environment. Employees must be able, with or without accommodation, to use a computer; communicate by phone, video, and electronic messaging; resolve problems; engage in analysis and discussion; collaborate; and maintain general availability during standard business hours. The role expects employees to work in the office at least three days per week, with flexibility around that expectation.

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 the 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 with 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 present 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, then synthesize it to support dissemination and incorporation into clinical development programs, asset plans, and therapeutic-area strategy.