Associate Director, Clinical Pharmacokineticist

Position : Associate Director, Clinical Pharmacokineticist

Location: Cambridge, UK

At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person.

The Associate Director designs and reviews clinical pharmacology study protocols, carries out non-compartmental pharmacokinetic analysis of clinical pharmacology studies using Phoenix/WinNonlin software along company guidelines, prepares interim, draft, and final clinical study reports. Prepares regulatory submissions and documentation related to non-compartmental pharmacokinetics. Works closely with Clinical Pharmacologists, Bioanalysts, Programmers, Clinical Research Organizations.

**Responsibilities**:

- Provides pharmacokinetic (PK) methodology for inclusion in analysis plans and clinical protocols or analysis plans
- Produce pharmacokinetic tables, figures, and listing shells are appropriate to detail the planned presentation of the results
- Create pre-lock tables, figures, and listing using non final data to allow review of their format
- Create associated datasets
- Conduct non-compartmental analyses (NCA), interpretation, and reporting of pharmacokinetic and, if needed, also for pharmacodymanic (PD) data in support of clinical studies using appropriate software like Covance’s Phoenix WinNonlin system (Certara)
- For interim analysis, work collaboratively with bioanalysis vendors to ensure scheduling of interim data transfers and rapid resolution of data queries
- For interim analysis perform pharmacokinetic (and pharmacodymanic) analysis and interpret the data to support dose progression
- Interpret and prepare the pharmacokinetic component of the Clinical Interpretation Meeting materials
- Write the pharmacokinetic sections of clinical study reports and, where appropriate, scientific manuscripts
- Reviews technical validity of non-compartmental analyses of performed by peers as quality control.
- Assists in development of departmental guidelines, processes, software, and training materials for non-compartmental analysis
- Depending on experience, trains and mentors other pharmacokinetists
- Supports Manager and Clinical Pharmacologists with Health Authority queries
- Prepares submission documentation and other documents for Health Authorities related to non-compartmental pharmacokinetic analyses.

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**Requirements/Qualifications**

**Education Required**:Bachelor’s or Masters degree in Science or Pharmacy

**Experience Required**:
4-10 years Pharmaceutical Industry and/or Academic experience in pharmacokinetic data analysis (i.e. Phoenix WinNonlin or similar) and report writing.

Knowledge of regulatory agency guidelines.

Effective time management and organizational skills.

***Desirable Skills/Abilities**:

- Experience with PK-PD modeling
- 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.
- Ability to develop and deliver effective presentations and written/oral communications.
- Thrives in a fast-paced business environment.

**Level of Supervision Required**:Work is performed with a moderate amount of supervision.

**Why AstraZeneca?**

At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial -finding those moments and recognising their potential. Join us on our journey of building a new kind of organisation to reset expectations of what a bio-pharmaceutical company can be. This means we’re opening new ways to work, pioneering cutting edge methods and bringing unexpected teams together. Interested? Come and join our journey.

**So, what’s next**

Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you.

**Where can I find out more?