Medical Director, Clinical Development Rare Cardiology

Alexion•Boston, MA

13h•Hybrid

About The Position

The Medical Director, Clinical Development, may lead or support the clinical subteam and the global program team to construct global clinical development plans and contribute to the development of asset level and therapeutic area strategies. You will be responsible for: The design and execution of multiple clinical studies or clinical programs Represent Clinical Development on the Global Program Team (GPT) and in presentations at management and review committees (e.g., Clinical Document Review Committee, Development and Commercial Steering Committee)! May have up to 12 Medical Directors for the program studies and/or Clinical Development Scientists or provide medical oversight. Work with one or more clinical study teams in the preparation of clinical 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 preparation for meetings Critically evaluate available information about diseases of interest to the therapeutic area and the competitive landscape and synthesize information succinctly to support dissemination and incorporation into clinical development programs, asset plans and therapeutic area strategy The Senior Medical Director Clinical Development will lead the clinical team for a high-visibility program and report to the Global Clinical Head. This is an excellent opportunity for an experienced and motivated drug developer to advance an innovative, late-stage study. The SD will provide medical leadership across late stage. Acting as a key medical expert on the study team(s), the SD may also serve as medical monitor as needed. In this role, the SD will work cross-functionally and mentor Physicians, Clinical Directors, and Clinical Development Scientists. The position may include direct and indirect managerial responsibilities for team members across the Clinical Development organization. The SD will also contribute to the development of regulatory, therapeutic area, and functional strategies. This position offers the opportunity to collaborate closely with enterprise-level, cross-functional teams, including AstraZeneca Business Units, CVRM, and strategic development partners. The ideal candidate will thrive in a fast-paced, proactive, and collaborative culture—demonstrating strong communication skills, scientific leadership, and the ability to drive impact across both internal and external teams. You will be responsible for: Lead cross-functional clinical program teams to deliver high-quality studies and research strategies, ensuring scientific rigor and optimal benefit–risk management. Serve as the clinical authority for assigned programs, overseeing study design, execution, data interpretation, and regulatory deliverables in compliance with GCP. Provide strategic medical and scientific input across R&D, translational science, commercial, and business development activities, including due diligence and collaborations. Mentor and develop Medical Directors, Clinical Development Scientists, and fellows to build organizational scientific and leadership capability. Represent the program internally and externally through governance presentations, regulatory interactions, scientific publications, and engagement with key opinion leaders.

Requirements

MD or equivalent
3+ years of clinical experience preferably within industry
Experience as a medical monitor for clinical trials
Publication in peer reviewed journals
MD with specialty training in Internal Medicine
7+ years of experience in clinical development; clinical research, global regulatory, and product development expertise
Has prepared documents and attended regulatory meetings with FDA and other regulatory agencies
Experience designing and executing multinational clinical trials required
Demonstrated ability to lead cross-functional teams to define clinical strategy and clinical study design
Experience supporting business development activities
Ability to learn rapidly, think critically, and operate effectively in a fast-paced environment
use a computer; engage in communications via phone, video, and electronic messaging; problem resolution; engage in nonlinear thought, analysis, and dialogue; collaborate; maintain general availability during standard business hours

Nice To Haves

Board Certification
Knowledge of the assigned therapy area with the capability to interpret, discuss and represent trial or program level data
5+ years of industry experience in clinical development
Experience for 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 the principles of clinical trial methodology, statistics, data analysis and interpretation
Experience authoring study essential documents, Clinical Study Reports, and regulatory documents
Board Certification
Experience in ATTR amyloidosis
Advanced knowledge of the assigned therapy area is desired, with the capability to interpret, discuss and represent trial or program level data
PhD in related discipline desirable
Experience with BLA/MAA submissions
Demonstrated experience as a clinical trialist with a strong external network, including relationships with key investigators, sites, and patient partners
Experience operating at the clinical-commercial interface and shaping clinical strategies with commercial insight
Broad awareness of the global therapeutic landscape and regulatory environment within rare or cardiometabolic diseases
Willingness and ability to travel nationally and internationally
use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours

Responsibilities

The design and execution of multiple clinical studies or clinical programs
Represent Clinical Development on the Global Program Team (GPT) and in presentations at management and review committees
May have up to 12 Medical Directors for the program studies and/or Clinical Development Scientists or provide medical oversight
Work with one or more clinical study teams in the preparation of clinical 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 preparation for meetings
Critically evaluate available information about diseases of interest to the therapeutic area and the competitive landscape and synthesize information succinctly to support dissemination and incorporation into clinical development programs, asset plans and therapeutic area strategy
Lead cross-functional clinical program teams to deliver high-quality studies and research strategies, ensuring scientific rigor and optimal benefit–risk management
Serve as the clinical authority for assigned programs, overseeing study design, execution, data interpretation, and regulatory deliverables in compliance with GCP
Provide strategic medical and scientific input across R&D, translational science, commercial, and business development activities, including due diligence and collaborations
Mentor and develop Medical Directors, Clinical Development Scientists, and fellows to build organizational scientific and leadership capability
Represent the program internally and externally through governance presentations, regulatory interactions, scientific publications, and engagement with key opinion leaders