AstraZeneca

Senior Clinical Development Scientist - COPD

Expiring today

Location
Gaithersburg, USA, Maryland
Salary
Health insurance
Posted
17 May 2021
Closes
16 Jun 2021
Ref
R-108398
Contact
AstraZeneca
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

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.

Who we are

A high performing team, we are united and motivated by our shared purpose - to deliver life-changing medicines. We come to work each day to make a difference - to patients, society and our company.

Why we love it

If your passion is science and you want to be part of a team that makes a bigger impact on patients' lives, then there's no better place to be.

What you will do

The Project Scientist will provide scientific and clinical input to all aspects of late stage product development. This includes but is not limited to the design, delivery and interpretation of pivotal clinical trials and of studies that further characterize the overall benefit and risk and value of products in respiratory and immunology therapeutic area (TA) in late stage development. The Project scientist ensures that the safety evaluation process for the pivotal phase III trials is seamless and complete.

The project scientist would seek input from the appropriate functional specialists and coordinates these activities in support of clinical studies and programs. The objectives of the Project Scientist will be set by the Group Director in agreement with the Global Clinical Head(s) . The role will have a special focus on late stage clinical trials within the respiratory and immunology where the Project Scientist will work in close collaboration with the study team physician and other partners with all aspects of scientific input, clinical data quality metrics and safety evaluation.

Typical Accountabilities

  • Provide scientific leadership in the innovative design, execution and interpretation of clinical trials in one or more development programs.
  • You will be involved primarily in late stage (Ph2b -Ph3) clinical programs.
  • Provide expert scientific input into the preparation of regulatory documents and interactions with regulatory authorities.
  • 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
  • Present protocol and scientific results to multidisciplinary teams and key partners
  • Effectively collaborate with colleagues in other functions including Patient Safety, Regulatory Affairs, and Clinical Operations, and early development groups.
  • Provide scientific analysis and interpretation of data from ongoing studies and in the literature
  • 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, investigator's brochure.
  • Assist in planning for, and participate in investigator and coordinator meetings, representing the therapeutic area or region.

Education, Qualifications, Skills and Experience

Essential

  • Science degree (e.g. MS, PhD or PharmD), relevant equivalent clinical qualification, or other relevant university degree with experience from clinical development.
  • Three or more years of relevant pharmaceutical industry experience (multi-country clinical trials) is required.
  • Good understanding of design, execution and interpretation of clinical trials particularly in respiratory and immunology clinical development
  • Good teamwork and collaboration skills

Desirable

  • Experience with biologics
  • Respiratory or immunology experience

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 17th May 2021 and we welcome with your application; CV and cover letter, no later than 1st June 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

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