PK/PD and Other Jobs

Contact email address: qiang.lu@sanofi.com - 20th Jul 2018 [2897]

Dear All, There is currently an open position (Senior/Entry-level) in the PKDM group at Sanofi, Bridgewater, NJ. Qualified candidates will be hired at the level commensurate with their experience. Please see below for job description and forward to potential candidates. Thank you for your consideration. Contact : Qiang.Lu@sanofi.com To apply online, please visit https://sanofi.wd3.myworkdayjobs.com/SanofiCareers/job/Bridgewater-NJ/Manager--Pharmokinetics--Dynamics---Metabolism-_R2465110

Position Accountabilities

• Support project teams as a modeling and simulation (M&S) and/or pharmacokinetics, dynamics, and metabolism (PKDM) expert
• Conduct PK, population PK, PK/PD analysis, clinical trial simulation, and/or PBPK analysis
• Formulate and execute PK/PD and M&S strategies for specific projects
• Develop and review protocols, analysis plans, and study reports for M&S aspects
• Prepare IB/IMPD/IND and other regulatory documents, when needed

Knowledge And Skills

• Perform population PK and PK/PD analysis, clinical trial simulation, and/or PBPK analysis under minimal supervision
• Perform compartmental PK analysis and simulation
• Perform complex non-compartmental PK analysis
• Apply a logical and structured approach to file management
• Accurately and fully record pharmacokinetic analyses in an auditable manner consistent with GLP practices, where applicable
• Develop departmental procedures (SOP’s, Protocols, Safety Procedures)
• May train/mentor others

Scientific competencies:

• Serve as PKDM representative for projects, especially in the area of M&S
• May recommend a course of action to solve M&S issues
• Can act as a resource to address technical and theoretical issues in the M&S area
• Be able to operate in a multicultural environment and participate in international teams
• Understand the general scientific basis of protocols and overall study objectives as related to assigned studies.
• Participate in the preparation of protocols and/or analysis plans
• Prepare and issue preliminary notes, key results summaries, CSR sections, and stand-alone M&S reports with minimal review
• Can represent Sanofi to regulatory agencies
• Participate and/or present at departmental, external and international meetings within the company
• Prepare abstracts, posters and manuscripts for presentation and/or publication
• Present at external scientific meetings as appropriate
• Identify skill-sets necessary to advance career development
• Ensure that all assigned project activities are performed in compliance with current departmental SOP’s, guidelines, industry best practices and regulatory guidelines, and are conducted following acceptable scientific rationale.
• Possess excellent interpersonal communications skills commensurate with working in a multicultural organization
• Demonstrate a proficiency at scheduling multiple activities
• Monitor compliance with any appropriate Sanofi guidelines
• Independently accountable for meeting project timelines

Formal Education And Experience Required

• Technical expertise in several of the following areas: population PK and PK/PD modeling, Clinical trial simulation, PK/PD modeling and simulation, PBPK modeling, and
• Ph.D. with or without post-doctoral experience in a biological, chemical, mathematical, computer science or closely related discipline plus at least 4 years of relevant experience, or
• Equivalent theoretical and technical knowledge.

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Contact email address: alee@seagen.com - 18th Jul 2018 [2896]

Seattle Genetics is seeking a highly motivated and experienced pharmacokineticist to join our efforts in developing innovative therapies that improve outcomes for patients with cancer. The main focus will be preclinical, working with Research and Translational Sciences to evaluate novel small molecules and therapeutic proteins, and then helping to move development candidates through IND-enabling studies.

Qualifications:

• An advanced degree (PhD or PharmD) in a chemical, biological, pharmaceutical, or related field, with 0-5 years of experiences.
• An in depth knowledge of large and small molecule PK/ADME
• Hands-on experiences in LC-MS and in vitro incubations
• Proficient with Phoenix/WinNonlin or equivalent software
• Ability to identify key project related questions, build hypotheses and lead a team effort in solving problems
• Strong communication and presentation skills in small groups and for large audiences

External website http://www.seattlegenetics.com/careers/job-opportunities?p=job%2FoYSX7fwE

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Contact email address: kevin.brennan@modernatx.com - 13th Jul 2018 [2895]

Associate Director of Pharmacometrics

The Role: The Associate Director of Pharmacometrics is responsible for applying quantitative analysis methods and PK/PD modeling techniques in developing candidate drug products and serves as an expert to ensure that modeling and simulation (M&S) methods are utilized optimally in discovery and development activities. The Associate Director will plan and execute PK/PD M&S activities in the design and analysis of in vivo and in vitro studies in collaboration with a multidisciplinary team. Will be responsible for developing and implementing M&S strategies, conduct internal analyses and manage relationships with external vendors. The ideal candidate will work independently to make decisions impacting M&S goals and to support the design, execution, and analysis of clinical studies. Contribute to the development and implementation of M&S working practices and SOPs and assist in the development of internal infrastructure to facilitate internal analysis goals. Will maintain extensive scientific awareness and presence in pharmacometrics, publishes manuscripts and posters, presents at scientific conferences and other scientific forums. Engages with consultants and advisors in the field, as well as the scientific community at large.

Here’s What You’ll Do: The candidate will be responsible for:

• Conducting in-house pharmacometrics analyses
• Representing pharmacometrics as the subject matter expert on multidisciplinary project teams
• Overseeing external M&S activities, such as population PK, PK/PD, exposure-response, and PBPK analyses, clinical trial simulations, and other model-based analyses
• Establishing pharmacometrics capabilities and infrastructure
• Developing and executing M&S plans to support discovery and development
• Using state of the art M&S methodologies and quantitative principles to advance development candidates
• Participating in the preparation of abstracts and manuscripts for publication

Here’s What You’ll Bring to the Table:

• PhD or PharmD with a focus in pharmacokinetics, pharmacology, pharmaceutics or other related field and at least 7 years drug development experience
• Hands-on experience using pharmacometrics tools including but not limited to NONMEM, Phoenix, R, etc.
• Strong publication record in the area of pharmacometrics
• Experience in contributing pharmacometrics components for submission to regulatory authorities
• Deep understanding of pharmacometric principles and incorporation of M&S strategies into overall drug candidate development plans
• Ability to develop and deliver clear and concise presentations for both internal and external meetings
• Strong written and oral communication skills and a track record of achievement in publications and/or patent applications Candidate will be curious in exploring new path for drug discovery, bold in proposing creative experimental designs and ideas. Will work collaboratively with multifunctional teams and will be relentless in pursuing successful outcomes
• Outstanding written and verbal communication skills

External website http://https://www.modernatx.com/careers

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Contact email address: cornelia.boehnstedt@fu-berlin.de - 12th Jul 2018 [2894]

Call for applications within the interdisciplinary PhD program PharMetrX

The Graduate Research Training Program PharMetrX: Pharmacometrics & Computational Disease Modelling is an interdisciplinary PhD program bridging pharmacy and mathematics. It aims at understanding the drug-patient-disease interaction by analysing data of drug concentration, effect and disease profiles of pre-clinical/clinical trials and of therapeutic care.

We are currently inviting applications to start the PharMetrX Research+ Program or the PharMetrX Training+ Program.

The PharMetrX Research+ Program (Research + Training + Network) comprises an excellent research environment in the vibrant Berlin/Potsdam area, fascinating and innovative research projects in a highly relevant field, truly transdisciplinary supervision, an individual mentorship from one of the industry partners, a specifically tailored training program of compact modules, a network of peers and a highly competitive 3.5 years fellowship.

The PharMetrX Training+ Program (Training + Network) offers a specifically tailored training program of compact modules that convey the foundations in pharmacokinetics & pharmacodynamics, systems biology, statistics etc. as well as a network of peers. It is open for PhD students who have already started their PhD in the field of pharmacometrics or will do so soon.

Both programs are open to candidates with a university degree in pharmacy, mathematics/ statistics, bioinformatics, life sciences or medicine. See https://www.PharMetrX.de for further details.

Deadline for applications: September 15th, 2018.

PharMetrX is a joint program of Freie Universität Berlin and the Universität Potsdam, supported by a consortium of global research-driven pharmaceutical companies.

Charlotte Kloft & Wilhelm Huisinga Program Chairs

External website http://www.PharMetrX.de

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Contact email address: jchapman@haallc.com - 11th Jul 2018 [2893]

Director - Pharmacometrics/Modeling and Simulation

Job Description: One of our top clients is looking for an experienced Pharmacometrician to develop and implement modeling and simulation strategies.

Key Responsibilities:

• Create pharmacometrics a plan to support the drug development teams.
• Develop modeling and simulation strategies.
• Conduct analysis of PK/PD, exposure-response, disease progression, and systems pharmacology models.
• Interpret and report on clinical data in support of dosage selection.
• Maintain regulatory compliance in the teams.

Experience Level:

• Ph.D. in Pharmacometrics, Pharmacokinetics, Pharmaceutical Sciences, or related field.
• 3-5+ years of industry experience.
• Hands-on modeling experience; including analsysis of disease progression, systems pharmacology, and PK/PD modeling.
• Experience using modeling software such as NONMEM, WinNonlin, Phoenix, etc.

If you\\\'re interested in learning more about this opportunity feel free to send an email to Jay Chapman at jchapman@haallc.com.

External website http://haallc.com

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Contact email address: jchapman@haallc.com - 11th Jul 2018 [2892]

Staff Scientist - Quantitative Pharmacology

Job Description: One of our top clients is looking for an experienced Quantitative Pharmacologist to support the clinical development team.

Key Responsibilities:

• Develop and implement strategies for the cross-functional clinical development team.
• Utilize population-based and mechanism-based analysis strategies to support dosage selection.
• Develop PK/PD, population PK, exposure-response, and disease models.
• Analyze, interpret, and report on clinical data.
• Support regulatory activities and maintain overall compliance.

Experience Level:

• Ph.D. in Clinical Pharmacology, Pharmaceutical Sciences, or related field.
• 1-3+ years of industry experience.
• Experience analyzing population PK and PK/PD data, performing modeling and simulation, among other quantitative pharmacology activities.
• Experience using modeling software such as NONMEM, WinNonlin, and Phoenix.

If you\\\'re interested in learning more feel free to send me an email at jchapman@haallc.com.

External website http://haallc.com

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Contact email address: jchapman@haallc.com - 11th Jul 2018 [2891]

Director - Clinical Pharmacology

Job Description: One of our top clients is looking for an experienced clinical pharmacology leader to join their team.

Key Responsibilities:

• Serve as the clinical pharmacology expert on cross-functional clinical developmental teams.
• Create and implement clinical pharmacology plans.
• Oversee model-based drug development plans by providing support to modeling and simulation efforts.
• Conduct analysis of population pharmacokinetic and exposure-response models.
• Maintain regulatory compliance in the teams.

Experience Level:

• Ph.D. in Clinical Pharmacology, Pharmaceutical Sciences, or related field.
• 3-8+ years of industry experience.
• Clinical pharmacology and pharmacometrics expertise.
• Experience analyzing and reporting on population PK, PK/PD, and PBPK data.
• Experience creating and implementing development plans.
• Experience working with R, NONMEM, WinNonlin, and Phoenix.

External website http://haallc.com

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Contact email address: gunjan.shah1@sygeneintl.com - 5th Jul 2018 [2890]

Job Opportunity - Pharmaceutical Candidate Optomization Group at Biocon- Bristol Myers Suibb, Syngene International Limited.

Please find the Skills required for the same below.

External Job Description Required.

• Ability to quantitatively integrate ADME, PK and PD data of both small molecules and/or protein therapeutics in support of discovery programs     
• Conduct PK and advanced mechanistic PK/PD modeling and simulation using advanced computer softwares to support drug candidate selection
• Perform PK (/PD) modeling, multi-compartmental & non-compartmental analyses of preclinical PK (/PD) data

Ability to quantitatively integrate ADME, PK and PD data of both small molecules and/or protein therapeutics in support of discovery programs

Conduct PK and advanced mechanistic PK/PD modeling and simulation using advanced computer softwares to support drug candidate selection

Perform PK (/PD) modeling, multi-compartmental & non-compartmental analyses of preclinical PK (/PD) data.

If Interested, Request you share the resume on gunjan.shah1@syngeneintl.com

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Contact email address: Qiang.Lu@sanofi.com - 22nd Jun 2018 [2888]

Dear All, There is currently an open position (Senior/Entry-level) in the PKDM group at Sanofi, Bridgewater, NJ. Qualified candidates will be hired at the level commensurate with their experience. Please see below for job description and forward to potential candidates. Thank you for your consideration. Contact : Qiang.Lu@sanofi.com To apply online, please visit https://www.linkedin.com/jobs/view/701423284/

Position Accountabilities

• Support project teams as a modeling and simulation (M&S) and/or pharmacokinetics, dynamics, and metabolism (PKDM) expert
• Conduct PK, population PK, PK/PD analysis, clinical trial simulation, and/or PBPK analysis
• Formulate and execute PK/PD and M&S strategies for specific projects
• Develop and review protocols, analysis plans, and study reports for M&S aspects
• Prepare IB/IMPD/IND and other regulatory documents, when needed

Knowledge And Skills

• Perform population PK and PK/PD analysis, clinical trial simulation, and/or PBPK analysis under minimal supervision
• Perform compartmental PK analysis and simulation
• Perform complex non-compartmental PK analysis
• Apply a logical and structured approach to file management
• Accurately and fully record pharmacokinetic analyses in an auditable manner consistent with GLP practices, where applicable
• Develop departmental procedures (SOP’s, Protocols, Safety Procedures)
• May train/mentor others

Scientific competencies:

• Serve as PKDM representative for projects, especially in the area of M&S
• May recommend a course of action to solve M&S issues
• Can act as a resource to address technical and theoretical issues in the M&S area
• Be able to operate in a multicultural environment and participate in international teams
• Understand the general scientific basis of protocols and overall study objectives as related to assigned studies.
• Participate in the preparation of protocols and/or analysis plans
• Prepare and issue preliminary notes, key results summaries, CSR sections, and stand-alone M&S reports with minimal review Can represent Sanofi to regulatory agencies
• Participate and/or present at departmental, external and international meetings within the company
• Prepare abstracts, posters and manuscripts for presentation and/or publication
• Present at external scientific meetings as appropriate
• Identify skill-sets necessary to advance career development
• Ensure that all assigned project activities are performed in compliance with current departmental SOP’s, guidelines, industry best practices and regulatory guidelines, and are conducted following acceptable scientific rationale.
• Possess excellent interpersonal communications skills commensurate with working in a multicultural organization
• Demonstrate a proficiency at scheduling multiple activities
• Monitor compliance with any appropriate Sanofi guidelines
• Independently accountable for meeting project timelines

Formal Education And Experience Required

• Technical expertise in several of the following areas: population PK and PK/PD modeling, Clinical trial simulation, PK/PD modeling and simulation, PBPK modeling, and
• Ph.D. with or without post-doctoral experience in a biological, chemical, mathematical, computer science or closely related discipline plus at least 4 years of relevant experience, or
• Equivalent theoretical and technical knowledge.

External website http://https://www.linkedin.com/jobs/view/701423284/

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Contact email address: amit.taneja@glpg.com - 16th Apr 2018 [2887]

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 know how to work independently and within a team. Your reactivity allow you to handle short delay and high pressure in competitive projects.

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

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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

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

External website https://career5.successfactors.eu/sfcareer/jobreqcareer?jobId=174818&company=merckgroup&username=

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Contact email address: Cornelius.Amberger@merckgroup.com - 12th Apr 2018 [2884]

Team Lead, Head of Clinical Pharmacokinetics - Pharmacodynamics Analysis (m/f) (174235) 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 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:

• Ph.D. in pharmacokinetics/Pharmaceutics/Pharmacy or a related discipline and at least 5 years of relevant industry or government experience
• Expert knowledge in clinical research and development areas with demonstrated expertise and strong quantitative skills in PKPD data management and analysis using statistical and pharmacokinetic evaluation programs: SAS programming, Phoenix WinNonlin and PKS database, R
• Expert Knowledge of data standards (CDISC\\\'s SDTM and ADaM), IT/ program validation / ICH/GxP
• Excellent organizational, communication, and leadership skills
• Coaching, mentoring, and people management skills
• Fluent spoken and written English. Additional local language is an asset

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

External website https://career5.successfactors.eu/sfcareer/jobreqcareer?jobId=174235&company=merckgroup&username=

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Contact email address: ldzwart@its.jnj.com - 10th Apr 2018 [2883]

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 :

• PhD in a relevant life science discipline
• A fundamental understanding of drug discovery and development and the role of pharmacokinetics.
• In-depth training and hands-on experience in pharmacokinetics and basic knowledge in mechanistic PK-PD (TK-TD) modeling
• Additional experience in absorption, distribution, drug metabolism, enzyme kinetics and transporter research is highly desirable.
• Ability to design, supervise and interpret various types of mechanistic ADME/PK and TK studies
• Proficiency in the development/optimization of new/existing experimental models to support hypothesis driven pharmacokinetic research.
• Prior experience with PK analysis (non-compartment & multi-compartment modeling) and a demonstrated ability to work with modeling tools (e.g. NONMEM, Phoenix, GastroPlus, SimCYP).
• Active scientific participation and collaboration with colleagues in industry, academia and regulatory agencies.
• Strong analytical thinking, excellent communication skills and the proven ability to work independently as well as effectively within a team environment
• Excellent oral and written communication skills in English

If interested apply via: https://jobs.jnj.com/jobs/1805639718W?lang=en-us&referring_service=email

External website https://jobs.jnj.com/jobs/1805639718W?lang=en-us&referring_service=email

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Contact email address: tycho.heimbach@novartis.com - 30th Mar 2018 [2881]

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 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.

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:
(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

EEO Statement
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.

Minimum requirements

• PhD in pharmacometrics/pharmacology or physiology/biomedical/chemical engineering, or related sciences with hands on experience with modeling tools such as MATLAB, Python, Phoenix, Simcyp, G+, etc. with a minimum of 3-10 years relevant industry experience
• Extensive modeling experience for biological/physiological/pathological/pharmacological systems
• Core competency in mathematics and numerical analysis including ordinary/partial differential equations, numerical optimization, stochastic modeling, etc.
• Exceptional problem-solving skills, learning agility, and collaborative behaviors
• Extensive experience with systems biology/physiology/pharmacology modeling or Virtual Human/Animal/Organ models, PBPK/PD modeling, translational PK-PD modeling, or data analyses
• Broad knowledge of drug discovery and development, e.g., on topics of drug delivery, formulation, ADME, PK/PD or TK/TD, etc.
• Excellent written and oral communication skills

Enter Job Number 237256BR on the webpage

External website https://sjobs.brassring.com/tgwebhost/searchopenings.aspx?partnerid=13617&siteid=5260

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21st Mar 2018 [2878]

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

• You establish high quality PK & PK/PD analysis, models and simulations, with special emphasis on innovative PBPK modeling approaches.
• Using modeling & simulations approaches as a tool for generating hypotheses, you support design of preclinical Proof of Principle/ Proof of Concept studies and predicting human PK.
• Furthermore, you provide expert modeling consultancy, training and support within Discovery Research.
• You plan, analyze, interpret and document of preclinical PK and PK/PD studies and present results of such investigations at internal and external meetings.
• In interdisciplinary interaction with experts from DMPK, Pharmacology and other scientists of research project teams, you guide and advice research project teams in all aspects related to DMPK issues.
• You promote and increase the application and impact of mechanistic modeling approaches, both within research and further beyond in preclinical and clinical development.

Requirements

• Ph.D. in PBPK modeling, Pharmacokinetics or a related field (e.g. systems biology, quantitative pharmacology, pharmacometrics, applied mathematics)
• Excellent hands-on expertise in expert M&S software (e.g. GastroPlus, SimCYP, PKSim, MatLab/Simbiology, PHX/WinNonLin)
• Thorough understanding of pharmacokinetics, physiology and pharmacology
• Fluent spoken and written English skills are required; basic German language skills or willingness to learn would be beneficial
• Excellent self-organization and the ability to work independently as well as in a team
• Good intercultural understanding

Contact
For further information please contact Recruiting Services: Mrs. Yue Pan, Tel: +49 (0) 7351 54 188546

External website http://https://tas-boehringer.taleo.net/careersection/jobdetail.ftl?job=1715427&lang=en

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16th Mar 2018 [2876]

There is currently an open position in the Translational Modelling and simulation group at Merck KGaA, Darmstadt.

The profile of the ideal candidate:
Support Drug Discovery and Development projects as a modelling and simulations expert with

1. Translational PK/PD for small and large molecules
2. PBPK modelling
3. DDI risk assessments
4. Manage modelling work that is out-sourced to CROs
5. To ensure high quality of documentation for Regulatory submissions

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.

External website https://career5.successfactors.eu/career?career%5fns=job%5flisting&company=merckgroup&navBarLevel=JOB%5fSEARCH&rcm%5fsite%5flocale=en%5fUS&career_job_req_id=173046&selected_lang=en_US&jobAlertController_jobAlertId=&jobAlertController_jobAlertName=&_s.crb=MZZIMp7vcQE06grixdX%2baFCdM34%3d

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Contact email address: jchapman@haallc.com - 13th Mar 2018 [2874]

Pharmacometrician - (Contract position) Location: MA

Job Description:
One of our top clients is looking for an experienced leader responsible for developing pharmacometrics strategies in support of clinical decision making.

Key Responsibilities:
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.

Experience Level:
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.

External website http://haallc.com/compas/?cjobid=AW811915216&rpid=125835

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Contact email address: laurent.nguyen@sanofi.com - 13th Mar 2018 [2873]

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:

• Implements innovative quantitative methods to integrate data of pharmacokinetics, pharmacodynamics, biomarkers and preclinical or clinical outcomes with information of patient characteristics, pathway biology, disease physiology and disease progression to facilitate quantitative decision making in support to projects.
• Elaborates and executes PBPK and PK/PD modeling strategies in order to support model informed drug decisions in discovery programs, in strong collaboration with preclinical teams (Biopharmacy, DMPK, pharmacology and toxicology)
• Works and communicates interactively with people from diverse scientific backgrounds in a multi-disciplinary environment and interacts effectively with project teams representatives
• Ensures quality of the study plan, protocols, reports, sections of reports required for regulatory submissions to health authorities
• Maintains state-of-the art knowledge of modelling techniques and works in compliance with guidance of regulatory authorities.

Education and Experiences Required:

• PhD or equivalent degree in pharmaceutical sciences, mathematics or similar disciplines with demonstrated expertise and a track record in PBPK and Pharmacometrics.
• Excellent programming skills (e.g.: R, Matlab, SAS,...) and solid hands-on experience (minimum of 3 years\\\' experience) in Population PK/PD modelling tools (e.g. NONMEM, Monolix, PFIM, STAN,..). Also practice in Physiologically-based pharmacokinetics modelling (e.g.: SimCYP, PK-sim MoBi, Gastro-Plus) would be a strong asset.
• Excellent written and verbal communication skills, with successful presentation capabilities
• At ease in working in a dynamic matrix organization and team player
• Proficient in spoken and written English and ability to communicate in French is an asset but not mandatory.

To apply or for further details on this position, please contact Laurent Nguyen by email: laurent.nguyen@sanofi.com

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7th Mar 2018 [2872]

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:
The Consultant Pharmacometrics will:

• Provide and support the services across the portfolio of pharmacometrics activities such as: translational modeling, PBPK population PK, PKPD, disease progression, survival analysis, and clinical trial simulation;
• Apply modeling and simulation approaches to advise on study designs and decision making in non-clinical, clinical and post-authorization development plans.
• Be responsible for applying quantitative approaches to support the drug development requirements of a wide range of clients from the pharmaceutical and biotechnology industry;
• Provide regulatory advice, prepare or review regulatory documents and act as client representative in communications and meetings with regulatory agencies;
• Guide and mentor the professionals in the Pharmacometrics Team. And contribute to the professional development of the employees in the clinical department;
• Interface with clients on a regular basis and function as the pharmacometric point of contact. Participate in business development and Requests for Proposals;
• Ensure successful and smooth business operations by developing new business opportunities, managing operations and the quality system for pharmacometrics.

Your Profile
The successful candidate will have:

• Ph.D. or equivalent in pharmacometrics, biostatistics, pharmaceutical sciences, or mathematics;
• Minimum 3 years of industrial or academic experience (post-Ph.D.) in practical applications of modelling and simulation;
• Practical experience in non-linear mixed effect modelling and of working with standard software such as NONMEM, R, SAS, Matlab, Winbugs, Monolix and ADAPT II;
• Ability to articulate modeling and simulation concepts in business relevant terms and to present ideas in business-friendly and user-friendly language;
• Team worker attitude with strong interpersonal skills and ability to communicate effectively at all levels in and outside the company;
• Prior experience in group leading/management and/or providing coaching to junior and mid-level pharmacometrician(s) is a plus;
• Professionalism with discretion, enthusiasm and a positive attitude;
• Fluent verbal and written English language skills.

How to apply:
Please forward your CV and motivation letter by email to Liane Brown-Feaheny, Human Resources Generalist, via careers@vennlife.com

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/

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Contact email address: anna.sher@pfizer.com - 21st Feb 2018 [2870]

Application call for a postdoctoral fellowship position at Pfizer, Cambridge, USA
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)

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

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21st Feb 2018 [2869]

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

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Contact email address: basiler2@gene.com - 5th Feb 2018 [2868]

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:
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.

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:
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.

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Contact email address: rrais2@jhmi.edu - 29th Jan 2018 [2867]

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:
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

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/