At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality! If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person.

As a Global Development Medical/Science Director with a focus on Cardiovascular/Renal or Metabolic dysfunction (including Diabetes, Obesity and NASH/MASH), you’ll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives. The successful Global Development Medical/Science Director in Late Phase CVRM (Cardiovascular, Renal, and Metabolic diseases) will be responsible for the design, conduct, monitoring, data interpretation and reporting of individual clinical trials ensuring that the clinical data collected within the study will allow determination of the benefits and risks of the compound, as well as allow for the intended label indication and price in markets globally. The individual will operate according to the highest ethical standards to align with internal SOPs, local regulations, laws, Good Clinical Practice, and regulatory requirements.

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

This role is based in our dynamic R&D site in Gaithersburg, MD.

What you will do:

Medical expert accountabilities

• Provide strategic medical and scientific knowledge and support the design, initiation, execution, completion, and interpretation of a clinical study
• Be accountable to deliver medical information, answers, and clarifications to Regulators, Ethics Committees, Marketing Companies, Investigators/Sites

Trial conduct and hands-on delivery accountabilities

• Accountable to the Global Clinical Head (GCH) for the medical aspects and design of studies. Also responsible for driving decisions within Study Team (ST) remits together with other ST members and for solving medical issues with the study team
• Oversight of medical and ethical components of studies including patient safety in compliance with GCP
• Deliver all relevant study documents (e.g Protocol, Amendments, Statistical Analysis Plan, Informed Consent Form, Case Report Forms, and Safety and Risk-Based Monitoring Plans)
• Conduct safety surveillance on a study level including the process for Adverse Events (AE)/ Serious AE reporting, the querying of missing/unclear data, the review of blinded safety data, and escalation to the GCH/Global Safety Physician when needed
• Be medically accountable for international investigator meetings, and support Marketing Companies in national activities
• Approve, with the GCH, the Clinical Study Report; including preparation and production (Introduction, Results, Discussion)

Messaging and external impact accountabilities

• Maintain a high degree of understanding and awareness of new and emerging medical developments, globally
• Apply strategic intent when working with Alliance partners, Regulatory Authorities, payers, opinion leaders, prescribers and consumers of AstraZeneca products
• Provide guidance for investigator-initiated trials in collaboration with regional marketing companies

Basic Qualfications:

• Graduate of a recognized school of medicine with an M.B.B.S. or M.D. degree OR PhD or PharmD with specialty or experience in the Cardiovascular, Renal or Metabolism (including obesity, diabetes, MASH) therapeutic areas,
• 3+ years of pharmaceutical industry experience OR 3+ years of clinical research experience in the academic or clinical practice setting
• Demonstrated partnership and collaboration skills, including acting as the leader and clearly communicating across countries and cultures
• Fluent in oral and written English, with good presentation skills and effective communication

Desired Qualifications:

• Clinical research expertise in relevant therapy area in study design, protocol development, monitoring and implementing clinical trials, interpreting and reporting trial results
• Credibility in scientific and commercial environments

Why AstraZeneca?
At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial -finding those moments and recognising their potential. Join us on our journey of building a new kind of organisation to reset expectations of what a bio-pharmaceutical company can be. This means we’re opening new ways to work, pioneering cutting edge methods and bringing unexpected teams together. Interested? Come and join our journey.

Date Posted

06-Aug-2024

Closing Date

12-Aug-2024Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.