Quantitative PK/PD specialist - Mechelen, Leiden, Romainville Job description
Within the Clinical Pharmacology group, you will contribute to the characterization of pharmacokinetics (PK) and pharmacodynamics (PD) of novel drug candidates.
Your principal accountabilities will be:
To perform non-compartmental PK data analysis for a wide range of Phase 1 studies (First-in-Human, Drug-drug interactions, relative bioavailability…)
Conduct physiological-based pharmacokinetic (PBPK) modeling analysis to support dose selection for first in human study and simulate drug-drug interactions for quantitative risk assessment
Implement population PK, PK/PD modeling and simulation to assist in selection of doses for clinical development and/or clinical trial simulations
Participate in preparing, reviewing and publishing scientific papers and abstracts
You will report to the Modeling & Simulation Sr scientist and work in close collaboration with Clinical Pharmacology Leaders. Requirements
The ideal candidate for this job has:
- a PhD or Master in Pharmacokinetics, Pharmacology or related field with a specific focus on pharmacokinetics and PK/PD modeling with at least 3-5 years’ experience in Clinical Development in Pharmaceutical Industry, Contract Research Organizations or academia
- Hands-on experience with one or more PK, PK/PD software packages (Phoenix, Monolix, R, NONMEM or similar)
- Hands-on experience with PKPB software (PKsim, SimCyp, Gastroplus) and or clinical trial simulations will be a plus.
You have a good written and oral communication, both in English and French.
http://careers.glpg.com/o/quantitative-pkpd-specialist-mechelen-leiden-romainville
External website http://careers.glpg.com/o/quantitative-pkpd-specialist-mechelen-leiden-romainville
Contact email address: marton.szilagyi@external.merckgroup.com - 13th Apr 2018 [2885]
PK/PD Scientific programmer (m/f)
A career at Merck is an ongoing journey of discovery: our 50,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.
Your role:
The PKPD Scientific programmer (m/f) will be responsible for conducting data-management and programming in support of the conduct, reporting, and submission of PK and PD analyses, including both non-compartmental and population analyses (NONMEM Input Files preparation). In addition, the PKPD Scientific programmer participates to improve efficiency and quality of dataset construction, analysis workflow, reporting, and submission of data to health authorities. Furthermore, you deal with validation of SAS Programs and you are responsible for the accuracy of SAS programs by reviewing output, reviewing code, reviewing log files and running plausibility checks.
Your qualifications:
- Completed university MSc degree, or equivalent in Data Sciences, Pharmaceutical Sciences, Statistics, Mathematics, or related fields with a minimum 3 to 5 years’ experience and expertise in PKPD data analysis, data management, reporting, and regulatory submission requirements.
- Proficiency in understanding of data collection and database concepts including data flows in clinical trials, and Pharma industry data standards, such as CDISC/SDTM and ADaM data models.
- Must be an expert in SAS dataset construction, with a strong preference for familiarity with PK and PKPD datasets (e.g., WinNonlin, NONMEM), R skills are a plus.
- Experience in validation of SAS Programs: reviewing output, reviewing code, reviewing log files and running plausibility checks
- Demonstrated ability to support and coordinate multiple projects and to produce the major deliverables associated with the planning, execution, and reporting of a clinical study.
- Experience in performing PK and statistical analysis using software (e.g., WinNonlin, Phoenix, AutoPilot and SAS, R) is a plus
- Strong collaborative skills, team player mentality.
- Excellent verbal and written communications skills in English
Curious? Apply and find more information at come2merck.com
External website https://career5.successfactors.eu/sfcareer/jobreqcareer?jobId=174818&company=merckgroup&username=
Contact email address: Cornelius.Amberger@merckgroup.com - 12th Apr 2018 [2884]
Team Lead, Head of Clinical Pharmacokinetics - Pharmacodynamics Analysis (m/f) (174235)
Your Role: The Head of PK/PD Data Processing will lead a team of PK/PD analysts who perform or oversee clinical PK and PK/PD data preparation, evaluation, visualization, and interpretation, and provide input to concept sheets, protocols, reports or presentations, informing and supporting (trial) teams and projects across all therapeutic areas. You will define, establish and maintain efficient, high quality processes and ensure that all PK/PD, submission-relevant analyses are provided on time and according to regulatory quality expectations. You will drive team members development, coaching, and ensure critical expertise, processes, and systems are maintained and sustained. The individual will effectively cooperate internally with various groups (Global early Development leads, clinical pharmacology, Biostatistics, Data Management, and Clinical Development) and with external partners to outsource clinical PK/PD work and oversees and track (e.g. through KPIs) study timelines, quality of deliverables, and budget.
Who you are:
External website https://career5.successfactors.eu/sfcareer/jobreqcareer?jobId=174235&company=merckgroup&username= Job Description:
This person will serve as a key scientific contributor in the Pharmacokinetics, Dynamics and Metabolism Group, providing pharmacokinetics expertise to project teams, toxicologists and other functional areas (Quantitative Sciences, PDMS) as required.
This person will be responsible for the design, conduct and interpretation of mechanistic in vivo and in vitro pharmacokinetic studies and employ latest preclinical PBPK/PD models for the projection of human exposure profiles as well as for the early identification of development risks/opportunities.
Additional responsibilities include protocol design/input for (hypothesis driven) Pharmacokinetics/Toxicokinetics studies, evaluating data and authoring company reports.
The incumbent will represent the department at various working group meetings to address PK/TK and ADME-related issues, and provide guidance on the appropriate use of this data for decision making purposes about compound progression.
Qualifications :
External website https://jobs.jnj.com/jobs/1805639718W?lang=en-us&referring_service=email Posting Title Senior Investigator, PK Sciences - East Hanover, NJ (237256BR)
Division NIBR
Business Unit Translational Medicine
Country USA
Work Location East Hanover, NJ
Company/Legal Entity Novartis Pharmaceuticals
Functional Area Research & Development
Job Type Full Time
Employment Type Regular
Job Description
The Senior Investigator is expected to develop/apply translational PK-PD modeling, PBPK-PD modeling, quantitative & systems pharmacology (QSP) modeling, along with data analysis techniques to facilitate drug discovery, development, and translational research across disease areas.
Key responsibilities will include:
EEO Statement
Minimum requirements
External website https://sjobs.brassring.com/tgwebhost/searchopenings.aspx?partnerid=13617&siteid=5260
Are you looking for a new career opportunity? Our innovation research department Drug Discovery Science located in Biberach, Germany is looking for a principal scientist for physiologically based pharmacokinetic (PBPK) modeling and simulation.
Tasks & responsibilities
External website http://https://tas-boehringer.taleo.net/careersection/jobdetail.ftl?job=1715427&lang=en There is currently an open position in the Translational Modelling and simulation group at Merck KGaA, Darmstadt.
The profile of the ideal candidate:
Pharmacometrician - (Contract position)
Location: MA
Job Description:
Key Responsibilities:
Experience Level:
External website http://haallc.com/compas/?cjobid=AW811915216&rpid=125835 Open full time position at Sanofi R&D - Modeling Scientits - Location: Paris (France)
Sanofi R&D is looking for a highly motivated and creative individual to join its Modelling & Simulation group in Paris. The individual will primarily be responsible for developing and executing PK/PD and Physiologically-based PK (PBPK) Modelling and Simulations (M&S) analyses to support drug development from discovery to late clinical stages in a variety of therapeutic areas (Oncology, Immuno-Inflammation, Central Nervous System, Cardiovascular, Infectious disease) for both small and large molecules.
The candidate must have strong experience in PK/PD, PBPK modelling in the pharmaceutical industry and/or academia.
Main Responsibilities & Accountabilities:
Venn Life Sciences is an Integrated Drug Development Partner offering a unique combination of drug development expertise and clinical trial design and management. This enables us to create, plan and execute drug and medical device development programs effectively and seamlessly for our clients. We have dedicated operations in Ireland, France, Germany, the Netherlands, the UK, the US, and European-wide representation.
Our vision is to deliver results of the highest quality to our global sponsors on time and within budget. We do this through developing our staff to be world class in their fields and forming real, lasting relationships with our clients.
Our Early Development Services Division is a leading partner in early drug development seamlessly integrating chemistry manufacturing and control, non-clinical development, early clinical development, regulatory affairs, quality assurance and project management.
We are currently seeking a Consultant Pharmacometrics to join our team. The position will be based in Breda, Netherlands and will report to the Director Clinical Pharmacokinetics, Pharmacometrics and Biometrics (PKPB). The position will be offered for a minimum of 32 hours per week. Initially, a one-year contract will be offered with the option to extend to a permanent contract. Depending on his/her competency and experiences, the successful candidate may assume the position of Group Leader Pharmacometrics.
The PKPB Department consist of the Clinical PK Team and the Pharmacometrics Team. The PKPB Department closely collaborates with the Clinical Development Department that provides clinical consultancy and clinical operations (medical writing, clinical trial management, pharmacovigilance).
Your Role:
For more information on our resourcing services visit: www.vennlifesciences.com
PLEASE NOTE THAT DUE TO THE HIGH VOLUME OF APPLICATIONS WHICH WE RECEIVE WE WILL ONLY BE ABLE TO REPLY TO CANDIDATES WHOM WE ARE INVITING FOR INTERVIEW External website http://www.vennlifesciences.com/careers/ Application call for a postdoctoral fellowship position at Pfizer, Cambridge, USA
If interested, please apply via the above link or contact anna.sher@pfizer.com External website http://https://pfizer.wd1.myworkdayjobs.com/PfizerCareers/job/United-States---Massachusetts---Cambridge/Pos Postdoctoral Fellowship in Pharmacokinetics/Pharmacodynamics
UNC Eshelman School of Pharmacy
University of North Carolina at Chapel Hill
A postdoctoral research position is available immediately to work on projects focused on characterizing the pharmacokinetic/pharmacodynamic properties of drugs used in the pediatric population. The projects will involve use of nonlinear mixed effects and physiologically based pharmacokinetic modeling techniques to identify optimal pediatric dosing and clinical trial design. Requirements: minimum of a PharmD, MD, or PhD with knowledge of PK/PD analyses.
Preferred experience: demonstrated software proficiency, including NONMEM and R or SAS, is preferred. Previous experience in performing in vitro drug metabolism or transporter studies is also preferred. Excellent communication skills and ability to work independently as well as a member of an interdisciplinary team are essential.
Interested applicants should submit a letter describing personal goals as they relate to the position, Curriculum Vitae, and 3 professional references at http://unc.peopleadmin.com/postings/134532
The University of North Carolina at Chapel Hill is an equal opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to age, color, disability, gender, gender expression, gender identity, genetic information, race, national origin, religion, sex, sexual orientation, or status as a protected veteran. External website https://unc.peopleadmin.com/postings/134532 Temp/Contractor Job Description (available 3-yr contract):
Position: Scientific Researcher(SR)/Senior Scientific Researcher(SSR)– Mass Spectrometry
Department: Assay Development & Technology (ADT), BioAnalytical Sciences (BAS)
Description:
The BAS/Assay Development and Technology (ADT) department is seeking a highly motivated Scientific Researcher (SR) / Senior Scientific Researcher (SSR) contractor to support antibody, antibody-drug conjugate (ADC) and other complex biotherapeutic projects in research and development. Responsibilities of this laboratory-based position will include quantification of recombinant therapeutic proteins, unconjugated drug and conjugated drug levels for ADCs and characterization of structural changes in these biotherapeutics, in biological matrices using LC-MS, and other analytical techniques. This individual will explore immuno-capture and mass spectrometry-based methods to support assessment of pharmacokinetics, and biotransformations of therapeutic antibodies, ADCs and other complex molecules in preclinical and clinical studies. This individual may also be involved in non-GLP sample analysis and data reporting. The individual will work independently and in collaboration with colleagues within BAS/ADT and across various functional areas. He or she may also be involved in evaluating and exploring innovative technologies.
Skills: In-depth knowledge and hands-on experience in HPLC and mass spectrometry with a proven track record of solving bioanalytical problems. Experience in quantitative LC-MS-MS method development is required. Expertise in bioanalysis of therapeutic proteins or proteomics is highly desirable. Specific hands-on experience with QTRAP 5500-6500, TripleTOF 5600-6600, and/or Orbitrap mass spectrometer technologies is a plus. The individual should be a motivated team player with excellent oral and written communication skills
Education/Experience:
The Johns Hopkins Drug Discovery (JHDD) team is seeking a skilled and motivated researcher with experience in Drug Metabolism and Pharmacokinetics. The program is multidisciplinary and focused on the discovery and development of novel small molecule drugs in the areas of Neurology, Oncology, Gastroenterology, Ophthalmology, and Immunology. The individual selected will be responsible for analytical method development (MS/MS), pharmacokinetic analyses, drug permeability analyses, drug metabolism (liver microsomes, S9, hepatocytes, etc.), and protein binding studies. In addition, he/she will be expected to also understand the absorption, distribution and elimination principles for application to the characterization of internal drug candidates.
JHDD will provide a dynamic research environment including interactions with JHU faculty, medicinal chemists, biochemists, cell biologists and in vivo pharmacologists, as well as interaction with several Pharma industrial partners.
Requirements for the position include:
Located in the new Biotechnology Park, Johns Hopkins Drug Discovery Program was created with the mission of identifying novel drug targets arising from JHU faculty’s research and translating them into new drug therapies for neurological disorders.
The integrated staff has expertise in medicinal chemistry, assay development, animal pharmacology/toxicology, drug metabolism and pharmacokinetics, and the knowledge necessary to bring novel drugs to the clinic. External website http://https://drugdiscovery.jhu.edu/ We are currently hiring some Pharmacometrics and Clinical Pharmacology positions for some leading global/local/start-up companies. Based in Shanghai/Beijing, China.
Pharmacometrics Position for a Leading Global company Title can be Principal Scientist/Sr. Principal Scientist.
Qualification:
PhD degree or above with 8 years industry experience;
Experience with Modeling&Simulation software(e.g. NONMEN Monolix Phoenix)
Good knowledge of clinical pharmacology and development processes.
Clinical Pharmacology Head Position for a Local Pharma
Qualification:
PhD degree or above with 12 years experience
Candidate must have experience both in Clinical Pharmacology and Pharmacometrics
Fluent in Chinese and English
Clinical Pharmacology Head Position for a Start-up Company
Qualification:
PhD degree or above with 12 years experience
Rich experience in Pharmacometrics and Clinical Pharmacology
If you are interested in this kind of position. Please feel to contact me.
External website http://www.af-recruiting.com The Novartis Institutes for BioMedical Research (NIBR) is the innovation engine of Novartis, focusing on powerful new technologies that have the potential to help produce therapeutic breakthroughs for patients. NIBR includes about 6500 associates across 7 locations worldwide. Translational Medicine (TM) is the clinical research arm of NIBR, and includes about 1000 associates globally. TM plays a pivotal role in bringing innovative medicines to patients, by building on research advances to develop new therapies, and bridging drug discovery and clinical application. PK Sciences (PKS) partners across both NIBR and the Global Drug Development organizations to advance the scientific knowledge of pharmacokinetics, metabolism and clinical pharmacology, and bring it to bear on drug discovery and development challenges throughout R&D.
We are currently seeking a senior Clinical Pharmacologist or DMPK expert (Investigator III) to join our team. The position will be based in Shanghai, China, and will report to the Director of PK Sciences, China Site Head.
Core Responsibilities: Lead the PK Sciences strategy (preclinical DMPK and clinical pharmacology) and influences project strategy for discovery, translational, development or lifecycle management programs in China.
The Division of Clinical Pharmacology V, Office of Clinical Pharmacology at FDA is recruiting clinical pharmacologists. The focus of our division is the development and regulatory evaluation of:
A Post-doctoral Position is available in the Department of Biomedical & Pharmaceutical Sciences at Chapman University School of Pharmacy in Irvine, California. The specific research includes the use of animal models to study the effects of liver diseases on the transporter- and/or cytochrome P450-mediated hepatobiliary and brain disposition of drugs. Candidates with a Ph.D. degree in Pharmaceutical Sciences with interest in the areas of pharmacology/ pharmacokinetics/drug disposition/drug metabolism will be considered. Additionally, the position requires prior experience with surgical procedures in rodents and analytical methods, such as LC/MS/MS, demonstrated by strong peer-reviewed publications. Excellent oral and written communication skills and ability to work independently or as part of an interdisciplinary team are essential. The successful candidate will work in a new research facility, which is equipped with the state-of-the-art research equipment.
Qualified applicants should submit a curriculum vitae, summary of research interests, and names/titles and contact information of three references electronically to Dr. Reza Mehvar (mehvar@chapman.edu). Review of applications starts immediately and will continue until the position is filled. The position is available on January 1, 2018.
Chapman University is an Equal Opportunity Employer, committed to providing career opportunities to all people, without regard to race, color, religion, sex, age, national origin, sexual orientation, disability, or veteran status. Pharmacometrics/Clinical Pharmacology Positions
We are currently hiring some Pharmacometrics and Clinical Pharmacology positions for some leading global/local/start-up companies. Based in Shanghai/Beijing, China.
Pharmacometrics Position for a Leading Global company
Title can be Principal Scientist/Sr. Principal Scientist.
External website http://www.af-recruiting.com
What we offer: At Merck, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!
Curious? Apply and find more information at come2merck.com. job req : 174235
Contact email address: ldzwart@its.jnj.com - 10th Apr 2018 [2883]
If interested apply via:
https://jobs.jnj.com/jobs/1805639718W?lang=en-us&referring_service=email
Contact email address: tycho.heimbach@novartis.com - 30th Mar 2018 [2881]
The Novartis Institutes for BioMedical Research (NIBR) is the innovation engine of Novartis, focusing on powerful new technologies that have the potential to help produce therapeutic breakthroughs for patients. NIBR includes about 6500 associates across 7 locations worldwide. Translational Medicine (TM) is the clinical research arm of NIBR, and includes about 1000 associates globally. TM plays a pivotal role in bringing innovative medicines to patients, by building on research advances to develop new therapies, and bridging drug discovery and clinical application. PK Sciences (PKS) partners across both NIBR and the Global Drug Development organizations to advance the scientific knowledge of pharmacokinetics, metabolism and clinical pharmacology, and bring it to bear on drug discovery and development challenges throughout R&D.
(1.) Serves as an expert modeler to provide translational modeling support for global drug development projects; (2.) Acts as a modeling liaison to bridge between the modeling line function and research/development teams from different disease or therapeutic areas; (3.) Performs and oversees biomarker PK / PD analyses using a variety of tools and approaches; (4.) Scripts/writes custom models; (5.) Integrates, interprets and reports data to project teams and other customers; (6.) Drives data-driven modeling at the drug discovery stage across disease areas; (7.) Develops and implements state-of-the-art modeling techniques (such as QSP or virtual human/animal/organ models) to impact drug development projects from discovery to early development; (8.) Demonstrates scientific creativity, collaboration works independently with project teams; (9.) Reviews and advises on translational modeling strategy for discovery programs; (10.) Executes modeling plans, and deliver reports of results
The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
Enter Job Number 237256BR on the webpage
21st Mar 2018 [2878]
Requirements
Contact
For further information please contact Recruiting Services: Mrs. Yue Pan, Tel: +49 (0) 7351 54 188546
16th Mar 2018 [2876]
Support Drug Discovery and Development projects as a modelling and simulations expert with
We would like a candidate with at least 3 years relevant experience in Pharmaceutical industry following a PhD in a relevant field. However, a motivated and energetic candidate without experience is also welcome to apply. Candidates may contact Sheila Annie Peters or use the link provided to apply for the position. Use Requisition ID 173046 to search for the position. Thank you.
Contact email address: jchapman@haallc.com - 13th Mar 2018 [2874]
One of our top clients is looking for an experienced leader responsible for developing pharmacometrics strategies in support of clinical decision making.
Implement pharmacometrics strategies to support the drug development team.
Analyze, interpret, and report on PK/PD, exposure-response, disease progression, and systems pharmacology models.
Develop modeling and simulation strategies for the team to support dosage selection.
Maintain regulatory compliance.
Ph.D. in Pharmacometrics, Pharmacokinetics, Pharmaceutical Sciences, or related field.
3-5+ years of industry experience.
Hands-on modeling experience including disease progression, systems pharmacology, and PK/PD modeling.
Strong understanding of PK/PD and pharmacometrics principles.
Experience working with R, NONMEM, Winnonlin, and Phoenix.
Contact email address: laurent.nguyen@sanofi.com - 13th Mar 2018 [2873]
Education and Experiences Required:
To apply or for further details on this position, please contact Laurent Nguyen by email: laurent.nguyen@sanofi.com
7th Mar 2018 [2872]
The Consultant Pharmacometrics will:
Your Profile
The successful candidate will have:
How to apply:
Please forward your CV and motivation letter by email to Liane Brown-Feaheny, Human Resources Generalist, via careers@vennlife.com
Contact email address: anna.sher@pfizer.com - 21st Feb 2018 [2870]
Postdoctoral Fellow, Systems Modeling
The Quantitative Systems Pharmacology (QSP) Lab in Pfizer’s Internal Medicine Research Unit (IMRU) is responsible for developing insights to help advance IMRU clinical candidates; identifying and evaluating promising new therapeutic targets through physiologically-based modeling and simulation; and analysis and interpretation of preclinical and clinical data. We seek a highly motivated postdoctoral candidate to develop and analyze mechanistic, mathematical models of cardiac and skeletal muscle mitochondria metabolism to enable the in silico testing of mechanistic hypotheses of metabolic inflexibility with the ultimate goal of improving the identification and evaluation of therapeutic targets for heart failure (HF) and type 2 diabetes mellitus (T2DM). Please visit the following link for more information:
https://pfizer.wd1.myworkdayjobs.com/PfizerCareers/job/United-States---Massachusetts---Cambridge/Postdoctoral-Fellow--Systems-Modeling_4692921
Starting date: March 2018 (negotiable)
21st Feb 2018 [2869]
Contact email address: basiler2@gene.com - 5th Feb 2018 [2868]
In the BioAnalytical Sciences (BAS) Department at Genentech, we are a world-class bioanalytical center of excellence for novel strategies, technologies, and methods that enable the development of life-changing medicines. We do this by fostering an innovative and collaborative environment that values and recognizes a diversity of contributions.
A BS or MS degree in Analytical Chemistry, Biochemistry or a related scientific discipline with specialization in mass spectrometry required. Industry experience in pharmaceutical or biotechnology drug development for 2-5 years preferred.
Contact email address: rrais2@jhmi.edu - 29th Jan 2018 [2867]
A bachelor or masters degree in biology, pharmacology, pharmaceutical sciences or related field
Knowledge of in vitro techniques, cell culture, LC/MS and pharmacokinetics is desirable
Ability to perform effectively in a team environment
Good oral communication and writing skills
Contact email address: a252919951@163.com - 6th Jan 2018 [2866]
Contact email address: sylvia.zhao@novartis.com - 6th Jan 2018 [2865]
Professional Requirements:
How to apply:
Please forward your CV (in English) by email to Sylvia Zhao, Director PK Sciences – sylvia.zhao@novartis.com
4th Dec 2017 [2861]
Interested candidates can submit Curriculum Vitae to Dr. Brian Booth ( brian.booth@fda.hhs.gov).
For information about Office of Clinical Pharmacology at FDA, please visit our website at https://www.fda.gov/aboutfda/centersoffices/officeofmedicalproductsandtobacco/cder/ucm106189.htm
Contact email address: mehvar@chapman.edu - 27th Nov 2017 [2859]
Contact email address: sam.huang@af-recruiting.com - 16th Nov 2017 [2858]
Qualification:
Clinical Pharmacology Head Position for a Local Pharma
Qualification:
Clinical Pharmacology Head Position for a Start-up Company
Qualification:
If you are interested in this kind of position. Please feel to contact me.