Detail

Salary
negotiable
Location
Cambridge, UK
Posted by: Astra Zeneca
04 May
59 Views
03 Jul expires

Global Clinical Development Medical Director

Cambridge, UK
Job Description

In this anticipated role in the Vaccines & Immune Therapies Unit, Late-stage Clinical Development function you will be given the opportunity to work on one or more of our current or new vaccine or monoclonal antibody programs for COVID-19, Respiratory Syncytial Virus (RSV) or Influenza, in a truly international working environment, with opportunities to interact with key external specialists, other medical colleagues and specialists in basic science, as well as commercial and regulatory functions.

 

Our Vaccines & Immune Therapies  therapy area aligned project teams of physicians and scientists provide clinical guidance and scientific leadership for clinical development programs within AstraZeneca's global organization.

 

The Global Clinical Development Medical Director will work in a wide range of aspects in pharmaceutical medicine, and due to the global responsibilities, there will be a multitude of internal and external contacts with investigator sites, health authorities, colleagues and marketing companies. This is an opportunity to take on the challenges of clinical development in a team of positive, collaborative, focused and highly motivated colleagues.

 

Dependent on the stage of the study, you will work with the clinical project team and support the Global Clinical Head (GCH) and Global Clinical Program Lead (GCPL) with the study design & results interpretation process, establishing clear design objectives for clinical programs and studies. You will support the Investigator sites in responding to site questions and have medical oversight of the safety and wellbeing of study participants. You will provide medical input into the content of core labelling texts and medical support for commercial activities, as well as the scientific component of the pricing and value strategy. You will also provide medical and scientific expertise as well as tactical and strategic medical input to the development of AstraZeneca’s compounds; primarily from Phase IIb to Phase IV.

 

Typical Accountabilities

  • In this position you will work alongside the GCH, GCPL and Clinical Scientists in providing medical and scientific leadership in the global development of new medicines targeted at indications in the field of infectious diseases e.g. COVID-19, RSV, Influenza.
  • You will have a meaningful role in the innovative design, execution and interpretation of clinical trials in one or more development programmes.
  • The role will require you to build strong relationships with a network of external scientific specialists and opinion leaders.
  • You will work closely with colleagues in other internal functions including Patient Safety, Regulatory Affairs and Clinical Operations.
  • You will be involved primarily in late stage (Ph2b and later) clinical programmes but will be expected to collaborate with clinical colleagues supporting Early (R&I) stage programs as well as medical affairs colleagues.
  • You will have medical oversight to ensure the safety of study participants including review of Adverse Events of Special Interest and Serious Adverse Events and review of safety narrative reports.
  • You will have medical oversight responsibilities for medical activities outsourced to third party vendors.
  • You will provide expert medical input into the preparation of regulatory documents and interactions with regulatory authorities.
  • You will provide expert medical and scientific analysis and interpretation of data from ongoing studies and in the literature.
  • You will participate in the preparation of publications and presentations at scientific meetings and congresses.



Job ID Reference
1585
Desired Skills & Experience
  • Fully qualified physician (MD or MD PhD) with significant clinical experience in the area of infectious diseases
  • Experience in late stage clinical drug development from pharma industry or CRO, at least 3-5 years  
  • Good understanding of clinical trials methodology
  • Experience in the design, execution and interpretation of Late Stage clinical trials (phase 2b-3) in the infection area or any other therapeutic area/ specialty in clinical development
  • Hands on experience of medical monitoring of phase 2b-3 studies
  • Hands on experience of working with Electronic Case Report and laboratory systems
  • Teamwork and collaboration skills
  • Good verbal and written communication skills in English
  • Ability to travel nationally and internationally
  • Willing to be office based at one of our AstraZeneca sites



Company
  Gaithersburg, Maryland, USA
  www.astrazeneca.com
AstraZeneca is an exciting global, innovation-driven biopharmaceutical company. We’re inspired by what science can do. Driven by the desire to meet unmet patient needs in our core therapeutic areas. Bold in our thinking. Proactive in pursuing discoveries beyond imagination. At sites across the world, we bring teams together in a spirit of collaboration to turn great ideas into life-changing medicines – strengthening our product portfolio and harnessing the potential of a pipeline across all stages of the drug development process.
You’ll be part of a team that’s rolling back the frontiers of science to turn yesterday’s impossible into the normal of tomorrow. So, if you share our focus and passion, join us and make a difference to patients – and in return, we’ll help you develop way beyond what you thought possible.
  Workplace
 Cambridge, UK