Global Clinical Development Medical Director
Location: Cambridgeshire, Gaithersburg, Maryland
Job Type: Full time
Do you have expertise in, and passion for clinical drug development? Are you looking to work at the cutting-edge, where scientific innovations and an entrepreneurial spirit are the norm?
We are building a team in AstraZeneca dedicated to Vaccines & Immune Therapies and are looking for passionate and motivated physicians with prior clinical development experience in immune therapies.
We therefore are interested to hear from you to start exploring your goals, objectives and career development paths for future opportunities.
AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines for some of the world’s most serious diseases. We are more than one of the world’s leading pharmaceutical companies.
The Vaccines and Immune Therapies (V&I unit) has been created to optimize AstraZeneca’s portfolio of vaccines and antibodies for infectious diseases (e.g. COVID, RSV, Influenza), as well as drive future discovery.
What you'll do
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.
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.
You will be 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.
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
So, what’s next?
This is a future opportunity and if you are interested to have an introductory conversation please apply via the link provided or contact firstname.lastname@example.org
Where you can 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/
Our Company Values & Behaviours underpin everything we do so please take a moment to familiarize yourself with them. You may also want to check out our new R&D Video showing how we turn Science into Medicines. Covid-19 Resources
More information about our sites:
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.
AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.