Clinical Pharmacokineticisit
AstraZeneca
Macclesfield, England, United Kingdom
5d ago

At AstraZeneca we work together across global boundaries to make an impact and find answers to challenges. We do this with the upmost integrity even in the most difficult situations because we are committed to doing the right thing.

We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people’s exceptional skills with those of people from all over the globe.

Position Summary

As the Clinical Pharmacokineticisit you will contribute to pipeline programs in clinical development and life cycle management and participate in the clinical pharmacology and pharmacometrics contributions for the assigned projects.

The Clinical Pharmacokineticist will work collaboratively with other scientists in clinical pharmacology and cross functionally with other groups within AstraZeneca.

Activities will include management of clinical pharmacology related sections of clinical trial protocols and externally-sponsored research, and representation on related project teams.

The Clinical Pharmacokineticist will also participate on submission teams for the Clinical Pharmacology and Quantitative Pharmacology (CPQP) Department and contribute to interactions with world health authorities regarding submissions and subsequent queries.

Major Duties and Responsibilities :

  • Represent CPQP on early and / or late-stage and / or life-cycle management project teams
  • Deliver relevant sections of clinical protocols, externally sponsored research, and clinical study reports by working with other scientists in clinical pharmacology in a matrix environment
  • Oversee related sections of externally sponsored clinical trials
  • Contribute to submission teams and coordinate contributions of functions, including clinical pharmacology, pharmacometrics, statistical sciences, drug metabolism and pharmacokinetics, biopharmaceutics, and bioanalytical
  • Interact with world health authorities including EOP1, EOP2 and marketing application related meetings
  • Collaborative review and approval of clinical documents including IB, CSR, PIP, PSP, marketing application sections, health authority briefing documents, and regulatory responses
  • Coordinates and coauthors external presentations and publications
  • Participates in Department-level initiatives
  • Requirements / Qualifications

  • Education Required : Ph.D., M.D or equivalent in a related discipline.
  • Experience Required : 0-4 years in combined industry and postdoctoral experience in the field of clinical pharmacology and pharmacometrics.
  • PhD in pharmacokinetics, pharmacology or a related field in the biological sciences.

  • Experience in the early and late stage development of small molecules and / or biologics is desirable. Basic understanding of the drug development process at preclinical and clinical stages.
  • Experience across disease areas is desirable.

  • Knowledge of related disciplines including pharmacometrics, statistics, bioanalysis, and translational science is desirable.
  • A record of external presentations and publications is desirable.

    Special Skills / Abilities :

  • Experience with PK-PD modeling and pharmacometrics
  • Team player works with others respectfully and cordially.
  • The ability to adapt, work through conflicts, and persuasively influence outcomes.
  • Effectively cope with change and is comfortable changing direction and acting without complete information.
  • Demonstrated ability to develop and present sound proposals and recommendations and influence and motivate others to achieve objectives.
  • Ability to develop and deliver effective presentations and written / oral communications.
  • Thrives in a fast-paced business environment.
  • Next Steps Apply today!

    To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity.

    If you know someone who would be a great fit, please share this posting with them.

    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 authorisation and employment eligibility verification requirements.

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