lobal Development Scientist Director

In this role, you will provide scientific and clinical input to all aspects of late stage product development.

The role

In this role, you will provide scientific and clinical input to all aspects of late stage product development. This includes design, delivery and interpretation of pivotal clinical trials, mechanistic studies, studies that further characterize the overall benefit, risk value of R&I Therapeutic Area (TA) products and in late stage development and other indications.

Main Duties and Responsibilities

The objectives of the Global Development Scientist Director will be set by the Senior Group Director in agreement with Global Clinical Head(s). Your role will have a special focus on late stage clinical trials within R&I, where you will work in close collaboration with the study team physician with all aspects of scientific input, clinical data quality metrics and safety evaluation.

You will be encouraged to collaborate with colleagues in the R&I development and early development groups. To be successful in your role, you will seek input from the appropriate functional experts and coordinate these activities in support of clinical studies and programs.

Furthermore, you will ensure that the safety evaluation process is seamless and complete and independently lead specific activities and contribute to science story preparation, regulatory submissions, process improvement and mentoring other scientists.

We will rely on you to:

  • Provide scientific leadership in the innovative design, execution and interpretation of clinical trials in one or more development programs.
  • Effectively work together with colleagues in other functions including Patient Safety, Regulatory Affairs, Clinical Operations and early development groups.
  • Be involved primarily in late stage (Ph2b and Phase 3) clinical programs but will be encouraged to collaborate with clinical colleagues supporting early stage programs as well as medical affairs colleagues.
  • Provide expert scientific input into the preparation of regulatory documents and interactions with regulatory authorities.
  • Provide authoritative scientific analysis and interpretation of data from ongoing studies and in the literature.
  • Lead development of quality metrics and data review plan for assigned studies
  • Support and contribute to medical monitoring of trials
  • Lead and participate in activities that ensure quality, consistency and integration of clinical study related deliverables and ensure safety evaluation process within the clinical team.
  • Ensure scientific input to TA standards
  • Provide scientific evidence to support strategic decision making for R&D, marketing, clinical, and business development departments.
  • Support and contribute to medical monitoring of trials
  • Lead development of quality metrics and data review plan for assigned studies
  • Develop and review protocols, informed consent and investigator’s brochure.
  • Renowned expert in own field and may specialize in more than one area. May coordinate the activity of a research team and holds full accountability for projects, often with Global impact.

Essential Requirements

You have a science or medical degree (e.g. MS, MD, PhD or PharmD), complemented by considerable relevant experience in respiratory, inflammatory or autoimmune diseases clinical trials from pharmaceutical industry or academia.

  • Good transferable project experience across phases I – III drug development.
  • Experience managing and interpreting the results of clinical trials as well as exposure to writing protocols to some degree and/or contribution to key study documents and processes. .
  • Strong analytical skills and experience of authoring scientific documents.
  • Sufficient technical and disease area knowledge to be able to interact with confidence with internal and external partners.
  • Excellent verbal and written communication, presenting scientific results to multidisciplinary teams and key partners.

Desirable Requirements

  • Experience leading and managing activities that require cross functional collaboration, good communication and passion for customers.

Why AstraZeneca

At AstraZeneca, we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration. Always committed to lifelong learning, growth and development.

Salary: Competitive

So, what’s next?

Are you already imagining yourself joining us? Good, because we can’t wait to hear from you!

Advertising opens on 14th Feb 2021, and we welcome with your application; CV and cover letter, no later than 14th March 2021

For more information please contact: alexander.doyle@astrazeneca.com

Additional information

Our Company Values & Behaviors 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:

  • Cambridge, UK
  • Gothenburg, Sweden
  • Gaithersburg, US

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