Clinical Pharmacokineticist - Clinical Pharmacology & DMPK
Location - Cambridge (UK)
If you're inspired to work for a world premier biotechnology company delivering life-changing products- join us.
MedImmune is the worldwide biologics research and development arm of AstraZeneca. We have one of the most robust pipelines in the industry. You will 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 medicines.
As a Clinical Pharmacokineticist in the Clinical Pharmacology and DMPK (CPD) team in Cambridge, UK you will be 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.
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
As a Clinical Pharmacokineticist you will represent biotherapeutic projects at various stages of research and development (target validation through life-cycle management).
Key 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.
- 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 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.
- Educated to BSc or equivalent and PhD strongly preferred.
- Expertise with standard modelling and simulation software (NONMEM, S-Plus/R, etc) is required.
- Knowledge of the use of modelling simulation and its role in discovery and development of therapeutics is required.
- Expertise in other modelling software (e.g. MATLAB, Berkeley-Madonna, etc) is highly desirable
- Knowledge of bioanalytical expertise, especially of biologics is desirable.
- Knowledge of biologics discovery and development - especially knowledge of bioanalytical strategy and GLP is desirable.
Candidates will be assessed at both the Clinical Pharmacokineticist and Senior Clinical Pharmacokineticist levels commensurate on experience.
Next Steps - Apply today!
To be considered for this exciting opportunity, please complete the full application on our website. If you know someone who would be a great fit, please share this posting with them.
MedImmune is an equal opportunity employer. MedImmune 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.
Closing date for applications 4th October 2017
Competitive remuneration and company benefits apply.