Bring out the best in each other, and yourself, by working together as one
In our dynamic environment, be supported by the brightest minds working together side by side. Agile and collaborative, we work cross-functionally, as well as externally, to thrive at pace.
How we do it
Committed to living our values – they guide our behaviours, actions and decisions, everyday.
It drives us to work together as one global team to achieve our goals. A supportive place where all are encouraged and achievement is recognised. Strengthening our knowledge through constructive feedback and coaching, as well as collaborating with the best.
Why we love it
You will be valued. Not only for your unique contribution, skills and background, but because we recognise people are our greatest asset. Here we are dedicated to being a Great Place to Work.
What You’ll do
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.
Major Duties and 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 (Pharsight)
- 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.
- Bachelor’s degree in Science or Pharmacy
- 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.
- 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.
Location: Cambridge, UK
So, what’s next?
Are you already imagining yourself joining us? Good, because we can’t wait to hear from you!
Advertising opens on 19th October 2021 and we welcome with your application; CV and cover letter, no later than 19th November 2021
For more information please contact: firstname.lastname@example.org
Our Company Values & Behaviors underpin everything we do so please take a moment to familiarize yourself with them. You may also want to check out our new R&D Video showing how we turn Science into Medicines. Covid-19 Resources
More information about our sites:
- Salary £30000 - £31000
- Salary Per annum