Clinical Development Manager - Oncology / Immunology / CNS
- Experience Level
- Experienced (non-manager)
I am partnered with an innovative pharmaceutical company working within a variety of therapeutic areas including oncology, immunology and CNS. The company has a particular focus on addressing areas of high medical need where current treatment and patient satisfaction is low.
The client combines both the drug discovery and the clinical research aspect of the drug development lifecycle to advance innovative drugs on a global level.
If you are a Scientist or Medical Doctor with a strong background in clinical trials and research, please read further:
Working with the Science director, you will work closely within cross-functional teams including the study team, project team and internal and external consultant within the whole product lifecycle. You will establish and ensure that the study protocol is contestant with the development plan and maintain quality of data and perform appropriate analysis and reporting of the relevant study data.
- Developing, maintaining and implementing the protocol and study documents relating to the clinical science aspects of the trial. Including but not limited to; study protocol, study reports, data reviews and study development plans.
- Responsible for the quality assurance of the clinical aspects of the trials, including but limited to; study protocol, clinical study reports and clinical data review.
- Responsible for the data review of the trial, including protocol deviation, safety data, efficacy data, data trends and adherence to protocol to ensure objectives are met.
- Managing internal and external functions to report concurrent reviews and results to ensure project plans are met.
- Working with cross-functional teams for production and analysis of pharmacokinetic data and any other specific requirements related to the clinical science aspects of the trial.
- Working in line with GCP and GMP regulations and ensuring training is up to date at all times.
- Contributing to the development and implementation of company SOP’s and policies.
- PhD or MD
- >3 years within the pharmaceutical, biotech or CRO environment.
- Experience developing study protocols, clinical study reports and clinical data reviews.
- Proven experience with regulatory, including ICH and GCP guidelines
- Experience in Phase I-II Clinical Trials
- Experience working in a multifunctional team environment working towards times deadline and resource pressures.
- Competitive Basic Salary
- Enhanced bonus Scheme
- Flexible working
- Pension Scheme
- Private Healthcare and Dental
- Life Insurance
To learn more, please reach out to me directly or apply here.
Adam J. Bloomfield
Principal Consultant Europe
abloomfield (@) Barringtonjames.com