Global Development Scientist Director

Astrazeneca PLC Gaithersburg , MD 20877

Posted 6 days ago

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.

We are now recruiting a dedicated Global Development Scientist Director to strengthen our team within Late Respiratory and Immunology (R&I) Clinical Development. This role can be based in Gothenburg (SE), Warsaw (Poland), Cambridge (UK) or Gaithersburg (US). 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'll do

As a Global Development Scientist Director you will provide leadership in 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.

In this role you will seek input from the appropriate functional professionals and will coordinate these activities in support of clinical studies and programs. You will lead many of these activities and will also contribute to process improvement, and mentoring of colleagues. We believe that you are a highly motivated and creative individual that possesses the ability to work across a matrix environment to advance clinical drug development programs from target identification/validation through IND enabling activities. You are expected to effectively collaborate with colleagues in the late stage respiratory and immunology TA and early development groups. Other capabilities are to demonstrate clear, professional verbal and written communication, presenting scientific results to multidisciplinary teams and key partners. You will work as a member of a diverse and motivated team of researchers spanning across multiple divisions of Biopharmaceuticals R&D.

Typical Accountabilities:

  • Provide scientific leadership in the innovative design, execution and interpretation of clinical trials in late stage (Ph2b and Phase 3) clinical programs

  • Provide expert scientific input and collaborate with colleagues in other functions including Patient Safety, Regulatory Affairs, Clinical Operations, and early development groups. Support analysis and interpretation of clinical data

  • Organize and analyze data from clinical research to build new hypothesis

  • Lead medical monitoring of trials (safety and efficacy)

  • Lead activities that ensure quality, consistency and integration of clinical study related deliverables and ensure safety evaluation process within the clinical team.

  • Provide scientific evidence to support strategic decision making for R&D, marketing, clinical, and business development departments.

  • Present protocol and scientific results to multidisciplinary teams and key stakeholders

Lead the development and review of protocols, informed consent, investigator's brochure and other clinical development documents.

  • Provide expert scientific input into the preparation of regulatory documents and interactions with regulatory authorities.

  • Participate and present at Investigator meetings.

Essential for the role

  • Scientific doctoral level degree (e.g. PhD or PharmD), relevant equivalent clinical qualification, or other relevant university degree with extensive experience from clinical development

  • Five or more years of relevant pharmaceutical industry experience (multi-country clinical trials) is required.

  • Thorough understanding of scientific and clinical issues related to the design and implementation of clinical trials

  • Thorough understanding of the interpretation of trial results, particularly in the respiratory and immunology areas.

  • Proven leadership skills and ability to work collaboratively in a cross-functional setting.

  • Experience, particularly Phase II and Phase III clinical development and experience with regulatory submissions, life cycle management, advisory boards, annual safety updates.

Why AstraZeneca?

AstraZeneca is a global, innovation-driven BioPharmaceutical business that focuses on the discovery, development and commercialization of prescription medicines for some of the world's most serious diseases. But we're more than one of the world's leading pharmaceutical companies.

There are many opportunities to develop yourself and your career. From our diverse portfolio and teamwork to our cutting-edge innovations - it's a place for lifelong learning. Ultimately, it's more than a job. We know that our work impacts people with serious conditions, many of whom have no other alternatives. That's what drives us - the potential to impact over one billion patients worldwide.

What's next?

Would you like to join us? Good, because we cannot wait to hear from you! We welcome your application with CV and cover letter, no later than February 18, 2022.

Competitive salary and benefits package on offer.

Opening date: January 13, 2022

Closing date: February 18, 2022

Date Posted

13-jan.-2022

Closing Date

17-feb.-2022

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.

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Global Development Scientist Director

Astrazeneca PLC