Clinical Pharmacokineticist - Mountain View, CA | Biospace
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Clinical Pharmacokineticist

MedImmune, LLC

Mountain View, CA
Posted Date:
Position Type:
Full time
Job Code:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

Mountain View, California, United States
Job reference: R-013892
Posted date: Sep. 08, 2017

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 Clinical Pharmacokineticistin Mountain View, CA,  you’ll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives.

And we’re excited to share that our work at the Mountain View site (along with some other AstraZeneca Group Companies in the Bay Area) will relocate to South San Francisco by early 2018.  for more information on this new facility.

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.

Main Duties and Responsibilities

At MedImmune, Clinical Pharmacokineticist (CPK) scientists function as the global Clinical Pharmacology/DMPK (CPD) team representative for biotherapeutic projects at various stages of research and development (target validation through life-cycle management) and are responsible for all aspects of pharmacokinetic/pharmacodynamics (PKPD) -related support for biotherapeutic products, including design of studies, analysis and reporting of data, and communication of data in regulatory documents and meetings.   

Specific responsibilities include:

  • Responsible for providing clinical pharmacology expertise into clinical development plans, including the design, conduct and interpretation of relevant clinical pharmacology studies, including PKPD studies, analysis of data using complex PKPD modelling and simulation methodologies, development and delivery of regulatory strategy (e.g IB/IND, end of phase 2, and BLA) etc, and data analysis and reporting of clinical studies. 
  • Function as the sole point of contact for all CPD activities on projects at all stages of discovery and development and be able to influence team strategy using modelling expertise. 
  • They will also be integrally involved in assessing and managing analyses of PK/PD data, integrating clinical trial simulation strategies and disseminating the clinically relevant risk/benefit implications to the Company's clinical development teams.
  • Collaborate with biostatisticians, clinicians and clinical operation managers for the appropriate design of Phase I-IV studies; contribute to the investigators brochure, clinical study protocol and report analysis and reporting of data, and communication of data in regulatory documents and meetings. 
  • Help design and conduct translational PK/PD modeling and simulation to support drug design goals, designs of PK/PD and safety assessment studies, and dosing justifications for first-in-human clinical studies.
  • Collaborate with toxicologists on the design, monitoring, and reporting of nonclinical safety studies; prepare TK subreports; comply with good laboratory practice (GLP) regulations for GLP studies. Perform PK analyses for GLP studies per SOPs, record data and analysis results in GLP-compliant manner, ensure timely and clear communication with GLP SD/PI on GLP studies, contribute to GLP study reports. Train other Cambridge CPD staff on PK analysis using Winnonlin, as required.
  • Mentor/manage junior scientists, create intra- and inter-departmental dialogue on CPD issues, if required.
  • Represent MedI CPD at external scientific and regulatory forums through participation and external publications, if required.


Essential Requirements

  • Bachelor's or Master's degree in pharmaceutical sciences, biological sciences, chemistry or related field with BS, 5-10 years' experience; with MS, 2-8 years' experience
  • Or
    Pharm D with clinical pharmacology fellowship training or relevant industry experience (3-5 years)
  • Or
    PhD in pharmaceutical sciences or a related field (0-3 years of experience)
  • Expertise with standard modelling and simulation software (NONMEM, S-Plus/R, etc)
  • Knowledge of the use of modelling simulation and its role in discovery and development of therapeutics
Desirable Requirements
  • Expertise in other modelling software (e.g. MATLAB, Berkeley-Madonna, etc)
  • Knowledge of bioanalytical expertise, especially of biologics
  • Knowledge of biologics discovery and development - especially knowledge of bioanalytical strategy and GLP
  • Strong publication and record of impacting external science

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. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.