Medical Director Clinical Development, Amyloidosis and Rare Cardiology

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 AstraZenecas 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.

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.

You will need to have:

• 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 processfrom 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.

• The duties of this role are generally conducted in an office (in person/hybrid) environment. As is typical of an office based role employees must with or without an accommodation to: 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.

We would prefer for you to have:

• 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.

Working at Alexion

Were inspired to think differently to create better outcomes. By creating an unparalleled employee experience our organization is equipped to adapt and enrich employees with a productive engaging and enjoyable work experience while accelerating world-class leadership and innovation capabilities that can deliver on our mission. Each of us is accountable for delivering innovative medicines and supportive technology with integrity so we can truly understand and better the lives of people affected by rare diseases. Together we can transform lives every day The Highest Standards By operating with the highest standards of ethics and integrity we aspire to live up to the expectations of patients physicians and ourselves and to earn trust in our communities. Diversity We encourage diversity of backgrounds and ideas. We genuinely care for and respect each other working together as a high-performing team to deliver extraordinary results while embracing different perspectives. Dedication The dedication and passion of our employees enable us to stay focused on what matters most. We push ourselves to achieve the highest level of medical innovation and to redefine what it means to live with a rare -Office Hybrid This role has an expectation of working in the office a minimum of 3 days a week. When we put unexpected teams in the same room we unleash bold thinking with the power to inspire life-changing medicines. Inperson working give us the platform we need to connect work at pace and challenge perceptions. Thats why we work on average a minimum of three days per week from the office. But that doesnt mean were not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds with as wide a range of perspectives as possible and harnessing industry-leading skills. We believe that the more inclusive we are the better our work will be. We welcome and consider applications to join our team from all qualified candidates regardless of their characteristics.

We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment) as well as work authorization and employment eligibility verification requirements.

Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment training compensation promotion and other terms and conditions of employment based on race color religion creed or lack thereof sex sexual orientation age ancestry national origin ethnicity citizenship status marital status pregnancy (including childbirth breastfeeding or related medical conditions) parental status (including adoption or surrogacy) military status protected veteran status disability medical condition gender identity or expression genetic information mental illness or other characteristics protected by law.

The annual base pay for this position ranges from 241613.60 - 362420.40 USD Annual. Our positions offer eligibility for various incentivesan opportunity to receive short-term incentive bonuses equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs paid time off (i.e. vacation holiday and leaves) as well as health dental and vision coverage in accordance with the terms of the applicable plans.