Global Development, Medical Science Director

Do you have expertise and scientific reputation in the Metabolic Diseases research area? Are you excited by a role where you will provide global scientific leadership within your area of expertise to accelerate innovative science and turn ideas into life changing medicines? Would you like to apply your expertise in a company where we work together across boundaries to make the impossible a reality? Join us to be part of the discovery of future treatments for Cardiovascular, Renal and Metabolic diseases

We are now hiring a Global Development Medical/Science 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 Study Clinical Lead 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.

What You'll Do:

• Provide strategic medical and scientific knowledge (Cardiovascular, Renal, and/or NASH) and supports the design, initiation, execution, completion, and interpretation of a clinical study

• Maintain accountability for study designs

• Deliver medical information, answers, and clarifications to Regulators, Ethic Committees, Marketing Companies, Investigators/Sites

• Oversee Trial conduct and hands-on delivery

• Drive decisions within Study Team (ST) remits together with other ST members and for solving medical issues in the study team

• Oversee the medical and ethical components of studies including patient safety on a study level in compliance with GCP

• Oversee the 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)

• Oversee 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.

• Hold medical accountability for international investigator meetings, and supports Marketing Companies (MC) in national activities

• Approve (with the GCH) the Clinical Study Report; including preparation and production thereof (Introduction, Results, Discussion)

• Oversee 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

• Deliver analyses of clinical data in a balanced, statistically sound fashion, to drive interpretations and further idea generation

• Serve as a source of medical expertise for the Product Team, in analyses and interpretation of medical data

Essential Skills and Experience:

• Graduate of a recognized school of medicine with an M.B.B.S., M.D. degree or equivalent, and/or a graduate of a scientific doctorate (e.g. PhD or PharmD) or equivalent in a scientific discipline or Pharmaceutical Medicine

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

• Good knowledge of biostatistics, global regulatory environment and pharmacovigilance

• 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

Desirable Skills and Experience:

• Good general medical knowledge preferably in nephrology, cardiology, or NASH

• An understanding of pharmaceutical industry R&D, particularly of major clinical milestones and of the factors which influence drug development

• An understanding of the interplay between clinical, commercial objectives, drug safety and regulatory requirements

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

Date Posted

17-Apr-2024

Closing Date

30-May-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.