3 days ago

Clinical Pharmacologist

Actelion Pharmaceuticals Ltd

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Clinical Pharmacologist

Clinical Pharmacologist-(1700005S)Actelion Pharmaceuticals Ltd., a Janssen Pharmaceutical Company of Johnson & Johnson, is recruiting for Clinical Pharmacologist.As part of the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We collaborate with the world for the health of everyone in it.Actelion is a leader in the field of pulmonary arterial hypertension (PAH). Our portfolio of PAH treatments covers the spectrum of disease, from WHO Functional Class (FC) II through to FC IV, with oral, inhaled and intravenous medications.Job Responsibilities

* Leads appropriate phase I/IIa studies to ensure study deliverables on time, on budget, and with the appropriate quality
* Contributes to selection of, negotiation with and supervision of CROs (e.g., clinical, data management, biostatistics, and bio-analytical CROs)
* Writes and/or organizes the writing and/or review of study-related documents (e.g., protocol outline, protocol and protocol amendment, contract, informed consent, bio-analytical plan and report, case report form, monitoring guidelines, data management plan, statistical analysis plan, clinical study report, manuscript for publication)
* Works in close collaboration with a Modeling and Simulation Specialist to include the appropriate related components in the study protocol and analysis plan, contribution to the interpretation of results
* Contributes to the writing of the clinical sections of regulatory documents (e.g., investigator's brochure, IMPD, briefing books, clinical overviews, safety updates and clinical summaries of the application dossier)
* Develops a comprehensive understanding of the science related to a study and/or project and provides appropriate training in the medical/scientific aspects of the study to the appropriate Clinical Pharmacology representative (e.g. CRA, (Senior) PM)
* Acts as the primary liaison in the Clinical Pharmacology study team ((Senior) PM, CRA, DM)
* Contributes to the preparation of submission documents to IRB/IEC and Health Authorities
* Answers all scientific/medical inquiries from IEC/IRB and/or Health Authorities
* Manages monitoring aspects of the study including but not limited to initiation visit, first dosing, source data verification, site management, monitoring visit, database lock activities
* Responsible for the medical review of study data prior to database lock
* Responsible for all aspects of study protocols, reports, project summaries, and development plans with regard to regulatory requirements
* Interprets and presents study results to Life Cycle Team, Development Team and externally when appropriate (e.g., scientific advisory board, investigator meeting, congress, health authorities, etc.)
* Performs literature reviews and write position papers and scientific publications when required
* Provides expertise to the PK/PD section of protocol of phase IIb-IV studies
* Follows relevant quality control procedures to verify that the quality requirements for the trial-related activities are fulfilled

Candidate Requirements

* Strong academic background, i.e., a master in sciences (or equivalent), preferably a PhD and/or MD
* At least 1-2 years clinical research experience in academic or industry environment but preferably with drug development experience in Pharmaceutical/Biotechnology company
* Experience with Pharmacokinetic (PK)/Pharmacodynamic (PD) evaluation techniques
* Basic understanding of the roles and responsibilities of relevant functions involved in a clinical trial (e.g. biostatistics, data management, drug safety, CRO, bio-analytics etc.)
* Basic knowledge of regulatory guidelines related to PK and PD studies and evaluations
* Basic knowledge of ICH-GCP, other relevant Guidance documents and of regulations and requirements for clinical trial authorization in major countries
* Ability to handle and oversee multiple tasks simultaneously and to prioritize in a high-pace environment
* Excellent organizational ability and flexibility with a keen attention to details
* Good written and verbal communication skills; able to communicate effectively with internal and external contact persons in complex matrix organizations
* Team player with ability to work in a matrix environment
* Fluent written and spoken English
* Proficient IT skills

If you are interested in making an impact by working in a culture of innovation, trust and teamwork, we welcome your application.

Primary Location



:Clinical Development



Job Type


Job Posting

:Jul 3, 2017