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Senior Clinical Pharmacokineticist

Uppsala

Recruitment drug development

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In close co-operation with Clinical Trial Consultants (CTC), one of the leading CRO´s in Sweden, are we happy to announce an open position as Senior Clinical Pharmacokineticist. For further information and to apply please visit www.hpsearch.se. Welcome!

The Position

General

• Lead the strategy, generation/analyses/interpretations/reporting of data and

communications/agreements with external customers/regulatory agencies in the areas

of Clinical Pharmacology, Pharmacokinetics, Exposure-Response and

Biopharmaceutics

• Support all phases of translational research and development for all new molecular

entities and marketed products in all therapeutic areas

• Responsible for defining the relationship between drug exposure (e.g. concentrations

in blood) and efficacy measures (primary and/or secondary clinical outcomes or

biomarkers) to select the optimal dose and dosing intervals.

• Responsible for defining the relationship between drug exposure and safety measures

(clinical outcomes or biomarkers (e.g. QTc) to identify populations that may be at risk

of increased toxicity or decreased tolerability.

• Responsible for the selection, design and interpretation of all phase I studies including

first in human, bioavailability/ bioequivalence/food effect, drug interaction, pilot

cardiovascular (QTc), special population, pharmacogenetic and immunogenicity

studies.

• Provide clinical pharmacology support for design, conduct, analysis and reporting of

phase I and II studies

• Lead the programming and validation of WinNonlin/Phoenix programs for PK

analysis of study results

• Conduct the Non-Compartmental/Compartmental PK analysis and generate the agreed

tables, listings and figures

• Write the PK section(s) in Clinical Study Protocols and Clinical Study Reports

• Critically evaluate literature and in-house clinical pharmacology data and presents

clinical pharmacology information to external customers

• Act as a subject matter expert to CTC AB and external customers to provide scientific

and clinical pharmacology information to make the relevant decisions

• Assist in the development of PK-related Standard Operating Procedures (SOPs) and

processes

Position Qualifications:

• Ph.D.

• >5 years of experience in Pharmacokinetic/Pharmacodynamic positions within R&D

from Pharmaceutical and/or CRO industries

• Good knowledge of the Phoenix Software

• Good knowledge of clinical trials

• Good knowledge of MS Office

• Good knowledge of Good Clinical Practice (GCP)

• Good knowledge of written and spoken English and Swedish

About CTC

CTC Clinical Trial Consultants AB was founded 2011 and is 100% privately owned by employees. Building on a solid foundation of experience and competence in running early clinical trials, key staff members from the former Berzelius Clinical Research Center AB and Quintiles AB have founded a private company, CTC Clinical Trial Consultants AB (CTC), to support customers with hospital-based early phase (0 / I / IIa) clinical trials. CTC has a 12-bed, state-of-the-art, fully equipped clinical research unit at Akademiska University Hospital in Uppsala. The location of the unit is “next-door” (20 meters further down the hallway) to the central intensive care unit and to the neuro intensive care unit.

The unit was inspected by the Medical Products Agency in Sweden 2015 and received an approval for performing FIM trials.

Flexibility and responsiveness to customer requirements are easier to implement in a smaller organization. We, in collaboration with other specialists in our network, can offer the same resources and capabilities as substantially larger companies. Besides conventional phase I and IIa studies, one of our specialties in translational/exploratory medicine is methods (e.g. microdosing/microdialysis techniques) to get early indications of pharmacological activity in humans (healthy volunteers and/or patients).

Torbjörn Ströberg

+46 (0) 703 778 774

Ann-Katrin Broman

+46 (0) 707 55 50 94