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Location:
Gaithersburg, Maryland, United States
Job reference: R-047654
Posted date: Mar. 25, 2019
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If you’re inspired by the possibilities of science to change lives and you thrive when making brave decisions – join us.

MedImmune is the worldwide biologics research and development arm of AstraZeneca. Here, you’ll have the opportunity to make a difference in people’s lives every day. As one of the world’s premier biotechnology companies, our mission is centered on delivering life-changing products that advance world health, and help fight and cure disease.  As a Director, Fellow in Gaithersburg, MD, you’ll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives.

We’re constantly pushing the boundaries of science to deliver life-changing medicines to patients, with a passion for discovery and a pipeline to show for it. We’re pioneering innovative research and exploring novel pathways across key therapeutic areas including oncology, respiratory, inflammation and autoimmunity, cardiovascular and metabolic disease, and infection and vaccines. And we’re industry-leading in immunology, protein engineering and translational science. We offer a unique and strong collaborative network as part of the AstraZeneca family, as together we explore synergies between small and large molecules.

MedImmune has a dynamic environment that fosters collaboration and innovation. We attract top minds, and we nurture and build top talent.

Position Summary

The Fellow primarily will oversee pipeline programs in clinical development and life cycle management and direct the clinical pharmacology and pharmacometrics contributions for the assigned projects. The Fellow 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 Fellow will also lead BLA submission teams for CPD and interact with world health authorities regarding submissions and subsequent queries.

Major Duties and Responsibilities:

• Represent clinical pharmacology on early and/or late-stage project teams

• Manage and 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

• Lead BLA submission teams and coordinate contributions of functions, including clinical pharmacology, pharmacometrics, statistical sciences, and bioanalytical (PK, immunogenicity, and biomarkers)

• Interact with world health-care authorities for late-stage projects including 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

• Leads, mentors and coaches staff in CPD within a matrix environment

• Coordinates and coauthors external presentations and publications

Requirements/Qualifications

Education RequiredPh.D., M.D or equivalent in a related discipline.

Experience RequiredAt least ten 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 biologics is essential. Strong understanding of the drug development process at preclinical and clinical stages. Experience across disease areas including oncology. Experienced with health-care authority interactions and submission of world-wide marketing applications. Broad knowledge of related disciplines including pharmacometrics, statistics, bioanalysis, and translational science. Excellent record of external presentations and publications.

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 is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.

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Director, Fellow - Clinical Pharmacology
MedImmune

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