Medical Director Clinical Development, Amyloidosis and Rare Cardiology

AstraZeneca•Boston, MA

31d•Hybrid

About The Position

The Medical Director (Clinical Development, Regulatory and Safety), will hold an expert position within the Amyloidosis and Rare Cardiomyopathy therapy organization at Alexion, AstraZeneca Rare Disease. This is an exceptionally exciting and prestigious role, contributing significantly to Alexion and AstraZeneca's global objectives and the value targets of our portfolio. As the Study Physician, they are responsible for contributing to Amyloidosis and Rare Cardiomyopathy programs. This is an excellent opportunity for an experienced and motivated drug developer to contribute to advance an innovative clinical stage ATTR amyloidosis study. Moreover, this role offers the unique opportunity to collaborate closely with cross-functional teams at the enterprise level, including Astrazeneca Business Unit, CVRM, and several development partners, thereby enhancing the overall impact and reach of the position. The successful candidate will thrive in a fast-paced, proactive can-do culture, be a highly effective internal and external team player as well as a strong communicator and collaborator.

Requirements

MD with specialty training in Cardiology or Internal Medicine.
Minimum of 5 years’ experience in clinical research and drug development, including hands-on experience designing and managing industry-sponsored clinical trials.
Experience with medical monitoring of clinical trials.
Experience authoring key study documents (e.g. protocols, CSRs, regulatory submissions).
Deep understanding of the end-to-end drug development process—from interpretation of non-clinical data to clinical study design, execution, and regulatory interactions.
Strong foundation in clinical research methodology and biostatistics to enable innovative, data-driven clinical trial design and decision-making.
Thorough knowledge of FDA, EMA, MHRA, and ICH-GCP guidelines to ensure compliant and high-quality global clinical studies.
Demonstrated ability to lead complex projects and collaborate effectively across multifunctional teams to align on strategy and deliver results.
Skilled communicator with the ability to simplify complex concepts and present clear, concise recommendations to stakeholders and governance committees.
Adaptive problem solver with strong learning agility and the ability to navigate complex organizational systems.
High attention to detail and commitment to quality, paired with a strong sense of purpose, urgency, and accountability.
Proven record of achievement and excellence in execution.
Ability to learn rapidly, think critically, and operate effectively in a fast-paced environment.

Nice To Haves

Board Certification.
Experience in ATTR amyloidosis
PhD and/or publication record in peer-reviewed journals.
Experience with endpoint adjudication.
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.

Responsibilities

Serve as the clinical and scientific expert for the ATTR Amyloidosis program, providing strategic and operational leadership in late stage development.
Act as the clinical authority for assigned studies, overseeing design, execution, and data interpretation to ensure scientific rigor, data integrity, and adherence to GCP.
Lead ongoing data review, develop medical oversight plan, and lead medical monitoring to ensure quality, and consistency, including analysis of emerging efficacy, safety (SAE/SUSAR), pharmacokinetic, and biomarker data, as well as oversight of event adjudication and DMC/Steering Committee interactions.
Drive cross-functional alignment on clinical development strategy, integrating input from research, clinical pharmacology, translational medicine, regulatory, biostatistics, safety, CMC, medical affairs, and commercial partners.
Analyze and synthesize evolving scientific and competitive intelligence in ATTR amyloidosis to inform program strategy, study design, and organizational learning.
Stay at the forefront of medical advancements in ATTR amyloidosis, translating emerging data and trends into innovative clinical approaches.
Partner with cross-functional teams to prepare and deliver presentations for internal governance and external engagements (e.g., Clinical Document Review Committee, Development and Commercial Steering Committee).
Contribute to regulatory strategy and author key clinical sections of protocols, informed consent forms, investigator brochures, briefing books, statistical analysis plans, pediatric plans, and periodic safety reports.
Support the qualification and integration of disease and pharmacodynamic biomarkers for early efficacy assessment.
Provide clinical insight into external innovation and in-licensing opportunities as needed.
May mentor and oversee Associate Medical Directors and Clinical Development Scientists.
Collaborate closely with study teams to ensure high-quality clinical documentation, including protocols, charters, statistical summaries, presentations, publications, and regulatory submissions.