A privately held pharma-company is advertising a vacancy for a Principal Scientist - Clinical Pharmacology, based in their office in Switzerland. The company is active in the life sciences areas of drug development, GMP manufacturing of proprietary drugs, diagnostic tools, and investment management, and focuses on innovative treatments, such as in oncology with a focus on solid tumours, as part of their business. This is an exciting opportunity to work with a leading pharmaceutical organization and support their R&D operations to create new, viable treatments.
Job Responsibilities:
- Responsible for the scientific aspects of clinical pharmacology assessments in oncology trials of assigned projects, including pharmacometrics (PK, PK/PD, Exposure/Response), management of drug-drug interactions and QT prolongation risk evaluation; and of assigned clinical pharmacology studies from conception to final report, including first-in-human studies (SAD, MAD), bioequivalence, food effect, drug-drug interactions, TQT, special populations PK and ADME studies.
- Collaborates with Medical Science, Translational Science, Clinical Safety, Data Management & Biostatistics, Clinical Operations and Regulatory functions to ensure appropriate study designs are achieved for successful implementation of data analyses and accomplishment of intended study outcomes.
- Determine, in collaboration with the relevant functions within Research & Development, clinical dose selection and dose adjustment.
- Be a member of the project team and work in a collaborative and proactive way in a matrix environment.
- Responsible for authoring and reviewing documentation intended for regulatory submissions, including the relevant sections of INDs and NDAs.
- Responsible for identifying, overseeing and managing external vendors and consultants supporting the clinical pharmacology function.
- Liaises with KOLs and academic collaborators on state-of-the-art clinical pharmacology science and methodology.
- Identifies and communicates potential project hurdles, suggests solutions and establishes priorities and contingency plans.
- Ensures the successful preparation and presentation of all internal and external documentation relating to clinical pharmacology.
Skills and Requirements:
- PharmD with a PhD or a specialization in clinical pharmacology or pharmacokinetics.
- At least 5-8 years of direct experience in Biotech/Pharmaceutical industry.
- Proven track-record in early clinical phases of drug development, clinical pharmacology, clinical research concepts and practices, and/or contribution to drug development programs that resulted in one or more marketed drugs.
- Hands-on experience with PK and PK/PD data analysis (proficiency in Phoenix WinNonLin; good understanding of population PK, PK/PD, Modelling & Simulation techniques).
- Hands-on experience in authoring regulatory documentation (experience in attending regulatory meetings a plus).
- Experience in clinical pharmacology programs of oncology drugs (experience in paediatric trials or Asian trials a plus).
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
To Apply:
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Charlotte Allen at +44 203 854 2621 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
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