Medical Director, Clinical Development

AstraZeneca•Boston, MA

3d•$249,827 - $374,741•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 involves designing and executing multiple clinical studies or programs, representing Clinical Development on the Global Program Team and at management and review committees, and collaborating with study teams on clinical-study and regulatory documents. The Medical Director also selects advisory board participants and evaluates disease-area information and the competitive landscape to inform clinical development programs, asset plans, and therapeutic-area strategy. The duties are generally conducted in an office environment. The role has an expectation of working in the office at least three days per week, with flexibility around that expectation. Employees must be able, with or without accommodation, to use a computer, communicate by phone, video, and electronic messaging, solve problems, engage in analysis and discussion, collaborate, and maintain general availability during standard business hours.

Requirements

MD or international equivalent; preferably a hematologist.
At least 3 years of clinical experience, preferably in industry and/or Hematology.
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 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 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.
Evaluate information about relevant diseases and the competitive landscape, and synthesize it to support clinical development programs, asset plans, and therapeutic-area strategy.