Medical Director, Clinical Development Rare Cardiology

This is what you will do:

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

You will need to have:

• MD or equivalent

• 3 years of clinical experience preferably within industry

• Experience as a medical monitor for clinical trials

• Publication in peer reviewed journals

• The duties of this role are generally conducted in an office 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

• 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

TheSenior 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 therapeuticarea 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 culturedemonstratingstrong communicationskills scientific leadership and the ability to drive impact across both internal and external teams.

You willbe responsible for:

• Lead cross-functional clinical program teams to deliver high-quality studies and research strategies ensuring scientific rigor andoptimalbenefitrisk 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.

You will need to have:

• MD with specialty training in Internal Medicine.

• 7 years of experience in clinical development; clinical research global regulatory and product developmentexpertise

• Has prepared documents and attended regulatory meetings with FDA and other regulatory agencies.

• Experience designing and executing multinational clinical trialsrequired

• 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 andoperateeffectively in a fast-paced environment.

• The duties of this role aregenerally conductedin an office environment. As is typical of an office-based role employees must be able with or without an accommodation to: 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.

We would prefer for you to have:

• Board Certification.

• Experience in ATTR amyloidosis

• Preferred: 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.

• Experienceoperatingat 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 249827.20 - 374740.80 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.

Date Posted

Closing Date

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and furtherance of that mission we welcome and consider applications from all qualified candidates regardless of their protected characteristics. If you have a disability or special need that requires accommodation please complete the corresponding section in the application form.