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Global Development Medical Director

Location Gaithersburg, Maryland, United States Job ID R-119393 Date posted 15/09/2021

Do you have a passion for Science?Would you like to apply your expertise to impact a company that follows the science and turns ideas into life changing medicines? Then AstraZeneca might be the one for you!

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.

Welcome toGaithersburg, MDone of over 400 sites here at AstraZeneca, providing a collaborative environment where everyone feels comfortable and able to be themselves is at the core of AstraZeneca’s priorities, it’s important to us that you bring your full self to work every day. To help you maintain your best self, here’s a sneak peek into some of the things this site provides for you…gym access, after-work events, lunch & learns, bright and spacious environment, sustainable office working environment and networking events.

As a Global Development Medical Director in Gaithersburg, MD, 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 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 will allow for the intended label indication and price in markets globally. The individual will operate according to the highest ethical standards in compliance with internal SOPs, local regulations, laws, Good Clinical Practice, and regulatory requirements.

Responsibilities/Accountabilities:

Medical expert accountabilities

  • Provides strategic medical and scientific knowledge (Metabolism and/or NASH) and supports the design, initiation, execution, completion, and interpretation of a clinical study
  • Is accountable for study designs
  • Is accountable to deliver medical information, answers, and clarifications to Regulators, Ethic Committees, Marketing Companies, Investigators/Sites

Trial conduct and hands-on delivery accountabilities

  • Is accountable to the Global Clinical Head (GCH) or delegate for the medical aspects and designs of studies
  • Is responsible for driving decisions within Study Team (ST) remits together with other ST members and for solving medical issues in the study team
  • Is accountable for the medical and ethical components of studies including patient safety on a study level in compliance with GCP
  • Is accountable for delivery of all relevant study documents (e.g Protocol, Amendments, Statistical Analysis Plan, Informed Consent Form, Case Report Forms, and Safety and Risk-Based Monitoring Plans)
  • Is accountable for 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 the escalation to the GCH/Global Safety Physician when needed.
  • Is medically accountable for international investigator meetings, and supports Marketing Companies (MC) in national activities
  • Approves (with the GCH) the Clinical Study Report; including preparation and production thereof (Introduction, Results, Discussion).
  • Is accountable for ST induction and education of new members in the study team, as well as others involved in the study
  • Collaborates seamlessly and efficiently with global colleagues at other R&D sites
  • May be accountable to GCH (or delegate) and leadership for identifying risks and proposing mitigation strategies to deliver successful Phase II, III, IV or Life Cycle Management studies

Scientific medical analytical accountabilities

  • Stays updated on relevant scientific literature
  • Delivers analyses of clinical data in a balanced, statistically sound fashion, to drive interpretations and further idea generation
  • Serves as a source of medical expertise for the Product Team, in analyses and interpretation of medical data

Messaging and external impact accountabilities

  • Maintains a high degree of understanding and awareness on new and emerging medical development, globally.
  • Works with international colleagues and with external Alliance partners on development initiatives and regulatory issues
  • Applies strategic intent of AstraZeneca when working with Alliance partners, Regulatory Authorities, payers, opinion leaders, prescribers and consumers of AstraZeneca products
  • Able to provide guidance for investigator-initiated trials in cooperation with regional marketing companies 

Minimum Requirements

  • Graduate of a recognized school of medicine with an M.B.B.S., M.D. degree or equivalent with specialty in Endocrinology, Gastroenterology or NASH expertise.
  • Proven teamwork and collaboration skills
  • Fluent in oral and written English
  • Good presentation skills and effective communication 

A clear demonstration of:

  • Leadership qualities, with particular focus on collaborative working skills, trust and openness, irrespective of cultural setting
  • AstraZeneca values and behaviors
  • Agile responsiveness to scientific data
  • Credibility in scientific and commercial environments

Desired Experience:

  • Good general medical knowledge preferably in Metabolism or NASH

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

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.

So, what’s next!

Are you ready to bring new ideas and fresh thinking to the table? Brilliant! We have one seat available and we hope it’s yours.

Where can I find out more?

Our Social Media, Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/

Follow AstraZeneca on Facebook https://www.facebook.com/astrazenecacareers/

Follow AstraZeneca on Instagram https://www.instagram.com/astrazeneca_careers/?hl=en



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 authorisation and employment eligibility verification requirements.

50056669 F CDPN R&D BioPharmaceuticals

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Great culture, great work assignments, supportive management. Rotation opportunity within the company. They value inclusion and diversity.