PK/PD and Other Jobs

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Contact email address: broseberry@cartermackay.com - 18th Nov 202 [3029]

Head of Pharmacometrics/Sr. Director role available in MA. Will supervise a group. Please contact me for more info.

Senior Director, Head of Pharmacometrics
Position Summary The Head of Pharmacometrics will be reporting to the Senior Vice President of Clinical Pharmacology and Pharmacometrics. In this position, the head of pharmacometrics is expected to provide strong technical and strategic leadership to a group of talented pharmacometricians and, strengthen and champion quantitative model based drug development across the organization. Will be responsible for pharmacometrics plan, conduct and review of modeling analysis for internal decision making and regulatory filings. Candidate should possess scientific curiosity and a passion for quantitative science based interrogation of data.
Major Duties and Responsibilities


Requirements/Qualifications
Special Skills/Abilities
Contact email address: telder@stem-sourcing.com - 18th Nov 202 [3028]

Senior Scientist or Entry Level Modeler Role

Responsible for supporting PK/PD, PB/PK, and population PK analysis of data from early discovery through clinical development. Knowledge and Skill Requirements

External website https://www.stem-sourcing.com


Contact email address: sabine.schaetzlein@boehringer-ingelheim.com - 11th Nov 202 [3027]

Senior Scientist Pharmacokinetics in Drug Safety and DMPK

Do you want to develop new innovative drugs to improve the health and well-being of dogs, cats, horses, cattle or swine? Are you seeking a new challenge and want to make a difference by acting globally and working cross functionally? This is your chance: welcome to our team!

TASKS & RESPONSIBILITES

REQUIREMENTS Location: Ingelheim, Germany

External website https://tas-boehringer.taleo.net/careersection/jobdetail.ftl?job=2011566&lang=en


Contact email address: gobeaun@mmv.org - 4th Nov 202 [3026]

PKPD/PBPK Translational Medicine Scientist (post-doc fellowship)

JOB PURPOSE

Medicines for Malaria Venture (MMV) is a leading product development partnership (PDP) in the field of antimalarial drug research and development. Its mission is to reduce the burden of malaria in disease-endemic countries by discovering, developing and delivering new, effective and affordable antimalarial drugs.

This 3-year post-doctoral fellowship will provide a PhD graduate with the opportunity to expand their scientific knowledge and skills, to see how pharmacometric approaches (PBPK and PK/PD) are used to speed up the drug development process, from early to late stage and to contribute to the development of innovative modeling approaches.

PRIMARY DUTIES AND RESPONSIBILITIES:

EDUCATION AND EXPERIENCE:

LOCATION: Geneva, Switzerland

External website https://www.mmv.org/about-us/work-us/jobs#op-420485-pkpdpbpk-translational-medicine-scientist


Contact email address: marc.trellu@sanofi.com - 25th Oct 202 [3025]

Contact : https://sanofi.wd3.myworkdayjobs.com/SanofiCareers/job/Chilly-Mazarin/Expert-Projet-DMPK-F-M_R2566361-1

Drug Metabolism and Pharmacokinetics (DMPK) research platform of the French Hub is seeking an experienced project expert mainly dedicated to Molecular Oncology and Immuno-Oncology projects. As a member of the DMPK department the individual will be an integral project team member representing DMPK on small molecule and biotherapeutics research projects to ensure effective integration of ADME, PK and PKPD into the team strategy. This includes contributing to screening funnel designs to ensure appropriate ADME characterization, driving appropriate characterization of clinical candidates for regulatory submission, and preparing IND/IMPD/CTA regulatory submissions. This role will be responsible for working with all the experts of DMPK as well as on global DMPK workstreams. The successful incumbent will have expertise to support project teams across multiple therapeutic areas including Molecular Oncology, Immuno-Oncology and Rare and Neuro Diseases. In this role he/she will contribute to the project team strategy at the early discovery phase up to first in human trials.

Requirements :

External website https://sanofi.wd3.myworkdayjobs.com/SanofiCareers/job/Chilly-Mazarin/Expert-Projet-DMPK-F-M_R256636


Contact email address: telder@stem-sourcing.com - 21st Oct 202 [3024]

Principal Scientist Clinical Pharmacology and Modeling and Simulations

Responsible for assisting with Clinical Pharmacology studies and to serve as the key person in the Clinical Pharmacology department for one of the company programs. This individual will analyze PK/PD data from clinical studies (Phase I-IV), using NONMEM, WinNonlin, SPLUS or SAS, and will write reports for regulatory submissions. This person will be required to provide scientific input for Clinical Protocols, clinical development plans, Investigator Brochures, and the Clinical Pharmacology section of INDs and NDAs and interact with contract research organizations (CROs). This individual will be expected to independently develop clinical pharmacology analysis plans, evaluate clinical trial data using advanced exploratory data analyses techniques, and perform clinical trial simulations and apply novel pharmacometric principles to assigned studies. Supervision of department staff may also be required.

Qualified candidates will have a PhD in Pharmaceutics, Clinical Pharmacology, Biostatistics, Chemical Engineering or Mathematical Biology and applicable experience in the pharmaceutical industry or within a regulatory agency. Candidates with more experience will be considered for the Director position. All candidates must have substantial knowledge of the requirements for the design, conduct, analysis, and report writing for regulatory submissions, in-depth understanding of drug metabolism and PK/PD principles. In addition, applicants must have experience working with SPLUS or SAS and NONMEM, have an understanding of clinical trial simulation and integration of PK/PD modeling in drug development and have excellent verbal and written communication skills.

Candidate with 2-3 years of industry experience are encouraged to apply as Scientist and Pharmacometrician level openings are online as well.

External website https://www.stem-sourcing.com


Contact email address: jchapman@haallc.com - 14th Oct 202 [3023]

Senior Scientist Clinical Pharmacology

Responsibilities

Job Requirements

External website https://http://haallc.com/career-opportunities?rpid=343137&postid=f6FmVxLB7II


Contact email address: Siak-Leng.Choi@sanofi.com - 8th Oct 202 [3022]

Pharmacokinetics/Pharmacodynamics Modeler Scientist (M/F) Chilly-Mazarin, France

The candidate will be responsible for:
Applying the modeling strategy defined up to the first In Human. Developing mechanism-based PK/PD, population PK/PD and PBPK model and performing evaluation & applications (simulation and extrapolation) Performing extrapolation to humans using appropriate models for informed conclusion and decision making in project teams. Presenting PKPD/PBPK activities within DMPK, and to internal/external experts in the field as well as in international conferences with posters/publications. Contributing to global workstream for the improvement of modeling tools and methodological development Education and experience requested :

A Ph.D. in Pharmacokinetics, PKPD/PBPK modeling, Pharmaceutical Sciences, Pharmacology, or related field with a specific focus on pharmacokinetics At least 3 years pharmaceutical industry experience in the conduct of pharmacokinetics and PK/PD support Advanced levels of using Monolix or Nonmem software. Experience in R and knowledge of MATLAB is also preferred. A good knowledge of SimCYP (PBPK software) is an asset. Experience in performing modeling and simulation for preclinical setting is an asset as well as a good knowledge in Oncology and Immuno-Oncology Flexibility is mandatory, the candidate must be able to adapt in a dynamic research environment Good communication and presentation skills.

External website https://en.jobs.sanofi.com/job/chilly-mazarin/pharmacokinetics-pharmacodynamics-modeler-scientist-m-


Contact email address: telder@stem-sourcing.com - 8th Oct 202 [3021]

Senior Scientist/Associate Director Clinical Pharmacology and Pharmacometrics

Exciting opportunity at a growing company that recently went public. Reporting to the Senior Director of Clinical Pharmacology this role will require a solid understanding of drug development processes including dose-selection for First-In-Human, Phase 2a/b and PK studies to support safety and efficacy of pharmaceuticals for therapeutic indications. Knowledge in pediatric drug development would is desirable. Highly motivated individual with a strong intellectual and technical background in Clinical Pharmacology/Biopharmaceutics disciplines. Hands-on experience with PK analysis (Phoenix WinNonlin) and data visualization techniques is a must. Proficiency in at least one advanced PKPD modeling and simulation software (e.g. NONMEM, Matlab, Monolix) is preferable. Regulatory experience (IND submissions, responses to Health Authority queries) desirable.

External website https://www.stem-sourcing.com


Contact email address: catia.marzolini@usb.ch - 3rd Oct 202 [3020]

Post-doctoral position in PBPK modeling: Basel, Switzerland
A fully funded postdoctoral position (100%) is available in the Division of Infectious Diseases & Hospital Epidemiology at the University Hospital of Basel. The research project aims to develop physiologically based pharmacokinetic (PBPK) models to simulate dosing requirements of long-acting intramuscular antiretroviral drugs in special populations and to manage drug-drug interactions with concurrent medications. The PBPK approach uses in vitro drug data and a mathematical description of drug absorption, distribution, metabolism and elimination (ADME) to predict the pharmacokinetics in a virtual population. This research project is of particular clinical importance, as it will provide guidance on dosing requirements in special populations, which were not evaluated comprehensively during drug development but which may also benefit from this novel treatment paradigm aiming to improve the chances of life-long maintenance of HIV suppression. In addition, this project will provide a comprehensive knowledge of factors influencing intramuscular drug disposition and improve the knowledge on drug-drug interactions with this route of administration.

The candidate must have a PhD degree and experience in PBPK modeling using the simulation softwares Matlab, R. Knowledge about principles in pharmacokinetics and drug metabolism is desired. This position is also open to candidates from the European Union and North America. The working language is English. German skills, although helpful, are not essential. Basel is a highly attractive city with a multinational population.

Application/contact
Please send one PDF file including CV with academic transcripts, publications, three academic references as well as a letter of motivation to: Prof. C. Marzolini: catia.marzolini@usb.ch Applications will be considered until November 15, 2020. The position is available from January 2021 for a period of 2 years. Please note that there will be no follow-up correspondence for applications that do not fulfill the position requirements.


Contact email address: broseberry@cartermackay.com - 23rd Sep 202 [3019]

Opportunity for Pharmaceutical Company, Work from home, Pharmacometrics--email me at broseberry@cartermackay.com for more info. Level is flexible.

ESSENTIAL DUTIES & RESPONSIBILITIES:
Develop or oversee vendors who develop mathematical models to understand a particular disease and its progression, pharmacodynamics (PK), pharmacokinetics (PK) and PK/PD; conduct meta-analyses as appropriate for characterization across populations as well as conduct simulations Effectively communicate PK and PK/PD modeling and simulation results Contribute to regulatory submissions or other regulatory documents and/or presentations Authors/reviews manuscripts for submission to peer-reviewed journals Evaluate and implement new pharmacometrics methods and approaches, which may include support and development of methodology, tools, software, or standard operating procedures

EXPERIENCE & QUALIFICATIONS:
PhD or PharmD Pharmaceutical Sciences, Clinical Pharmacology, Pharmacometrics, or related field with a minimum of 2 years of experience in pharmaceutical industry (CRO or pharma company) is required. MSc with significant experience will also be considered. Training and experience using modelling tools for quantitative clinical pharmacology such as NonMem, R, Phoenix WinNonlin, Winbugs, Simcyp, Gastroplus, SAS and/or MATLAB highly preferred; demonstration of effective management of pharmacometrics vendors in the absence of direct modeling experience may be considered. Experience in contributing to regulatory submission documents such as CTAs, INDs, NDAs, MAAs and BLAs Expertise with pharmacometrics, including PK, PK/PD, PBPK and statistics; strong quantitative skills Excellent verbal and written communication skills Knowledge of pharmacokinetics and model-based drug development Knowledge of global regulatory requirements, standards and processes specific to pharmacometrics


Contact email address: cornelius.amberger@merckgroup.com - 17th Sep 202 [3018]

Merck KGaA is currently looking for a Project representative Development NCE DMPK (all genders), based in Darmstadt (Germany)

Your role:
We are seeking an experienced Project Representative to join our Development NCE DMPK team in Darmstadt (GE).

The Project Representative, New Chemical Entities (NCE) DMPK is a strategic and scientific role within Discovery and Development Technologies (DDTech) in Research and Development (R&D).

You will be DMPK representative in project teams/subteams, ensuring that the proper flow of information between the project, the function, and key stakeholders is in place. You will support projects from early development to life cycle management, fulfilling internal and regulatory requirements. As project representative, you will identify DMPK related key issues, define the appropriate project plan, and ensure that studies are conducted on time and with the required quality. You will analyze and interpret in vitro/in vivo DMPK data, provide the project team on risk assessment and issue management, and contribute to clinical study protocol development.

Who you are:

External website https://career5.successfactors.eu/sfcareer/jobreqcareer?jobId=209042&company=merckgroup


Contact email address: broseberry@cartermackay.com - 16th Sep 202 [3017]

Sr. Scientist/Associate Director role in Pharmacometrics in NJ. Level pursuant to individual experience. Please email me for more info at broseberry@cartermackay.com

This individual will contribute to the pharmacometrics strategy. This role requires a strong and pharmacokinetics/pharmacodynamics/pharmacometrics knowledge, with hands on modelling and simulation skills, and will work in close collaboration with various internal functions. This role may also be able to supervise more junior-level Pharmacometricians and will also assist in interactions with senior-level external partners and consultants.

Job Responsibilities

Qualifications Minimum Education Requirement
8th Sep 202 [3016]

Nuvisan Pharma Services is looking for DMPK experts as DMPK expert, team lead, lab-head or laboratory scientist in all fields of DMPK, biotransformation, in vitro PK and in vivo ADME, for our sites in Grafing near Munich and Berlin. Check out our career site and learn more about the current job openings.....and more job positions to come.
We hope to welcome you soon!

External website https://nuvisan.odoo.com/jobs


Contact email address: kapraun.dustin@epa.gov - 1st Sep 202 [3015]

The Chemical Pollutant Assessment Division (CPAD) at the U.S. EPA's Center for Public Health and Environmental Assessment (CPHEA) is looking to hire a staff scientist with quantitative modeling expertise. We would like to find a candidate with knowledge of and experience with PBPK modeling. View the full position description and apply on USAJobs!

https://www.usajobs.gov/Search/Results?k=RTP-ORD-DE-2020-0090

Applications will be accepted through 9/8/2020.

External website https://www.usajobs.gov/Search/Results?k=RTP-ORD-DE-2020-0090


Contact email address: telder@stem-sourcing.com - 28th Aug 202 [3014]

Principal Scientist/Associate Director level DMPK Modeling and Simulations Role

Our Client in the Boston area is looking for a strong PhD level scientist to deliver mechanistic and quantitative PK/PD/efficacy relationships to support project teams from early discovery through early clinical development.

In addition, the individual will be involved in (PK) and (ADME) studies of to support drug development from early discovery through preclinical and clinical development. The individual will serve as DMPK project representative to coordinate and lead all nonclinical DMPK activities on programs from research phase through development. An individual with in-depth knowledge and expertise in PK/PD modeling and simulation and ADME is essential.

Responsibilities:

Provide quantitative and mechanistic PK/PD/efficacy relationships to support drug discovery and development teams Design/execute preclinical studies to understand the (PK) and (ADME) of drug candidates Represent DMPK as the subject matter expert on project teams, develop and drive DMPK and PK/PD strategy for Drug Discovery projects Participate and manage CROs in the conduct of in vitro/in vivo ADME studies

Qualifications

PhD. with years of experience in the biopharmaceutical industry, with evidence of modeling experience Fluency with simulations and modeling, and in depth hands-on modeling experience (e.g. using WinNonlin Phoenix, MATLAB/Simbiology, PK Sim, Simcyp, or NONMEM to develop PK/PD models) Solid knowledge of metabolism, ADM, PK/PD and bioanalytical principles is required. Experience with biologics desirable but not required. Strong communication and presentation skills required Excellent interpersonal skills

External website https://www.stem-sourcing.com


Contact email address: anthony.cunningham@duke.edu - 21st Aug 202 [3013]

Duke Clinical Research (DCRI) is seeking a pharmacometrician to join one of the world’s leading academic clinical research organizations. The Pharmacometric Center of Excellence has a strong history of both industry and government funding and combines thought leadership from clinical subspecialists with unique expertise in regulatory submissions and clinical pharmacology in special populations (e.g., children, pregnancy). The candidate will join a multidisciplinary team of clinical research professionals in a position that combines flexible working arrangements, cross-disciplinary mentorship, opportunities for publication, and room for personal growth and career advancement.

The ideal candidate will join cross-disciplinary study teams leading multicenter clinical trials across therapeutic areas conducted to support regulatory submissions to the US Food and Drug Administration and other agencies. As a member of the study teams, the pharmacometrician will provide scientific expertise in clinical pharmacokinetics to support study protocol development and analysis planning, perform pharmacokinetic (PK) and pharmacodynamic (PD) analyses, and prepare reports and integrated summary documents. Through this role, the pharmacometrician will have extensive interactions with scientific and clinical experts, operational leaders, and regulatory scientists to expand their knowledge base and expertise in regulatory compliant clinical trials. Results of analyses and trials will be disseminated via peer reviewed publications and presentations at national and international meetings, with ample opportunities for the pharmacometrician to author and lead author publications.

Work Performed Application of PK/PD techniques during all stages of drug development, including molecule selection, non-clinical dose and regimen selection, first-in-human studies, Phase II dose/regimen selection, and strategic and tactical decision-making for large Phase III clinical studies. There will be a focus on the evaluation and implementation of innovative trial designs to enhance the efficiency and provide better informed decision-making. Evaluation and understanding of PK/PD characteristics absorption, distribution, metabolism, and excretion (ADME) research on compounds, and associated variability of drugs in clinical development, using empiric, mechanistic, and population modeling approaches.

Education/Training: Work requires a minimum of a PharmD, MD, PhD in pharmaceutical sciences or pharmacology. Graduation from an accredited postdoctoral clinical pharmacology program. Or an equivalent combination of relevant education and/or experience.

Experience: Proficient in PK/PD or related analyses and extensive knowledge of and hands-on familiarity with software such as winnonlin and NONMEM software required. Ability to assemble and format data using programs such as R, SAS, Stata is a plus.

External website https://dcri.org


Contact email address: telder@stem-sourcing.com - 10th Aug 202 [3012]

Our client is searching for an experienced Senior Director, Clinical Pharmacology to serve as the area leader for Clinical Pharmacology and report to the Vice President, Head of Translational Medicine. The Senior Director will also manage the scientific functions and coordinate the activities of the Clinical Pharmacology division of Translational Medicine in collaboration with the other Disease Area leaders. The Senior Director’s responsibilities will include maintaining organizational processes across the group, influencing clinical program strategy, and integrating activities with other departments across the Global Research and Development organization, to help shape innovative and integrated clinical development plans. As the Disease Area leader for Pain and Neurology programs, the Senior Director will also direct Clinical Pharmacology efforts for small molecule and novel modality programs, such as gene editing, gene therapy, and cell therapy, in the Disease Area.

Key Responsibilities:

Manage a group of Clinical Pharmacologists at Director-level and below to set strategy, develop and execute Clinical Pharmacology plans and studies for Pain and Neurology programs
Manage department resources and sets priorities among competing projects and demands while communicating and negotiating the priorities
Support career development and management training for junior staff

External website https://www.stem-sourcing.com


Contact email address: broseberry@cartermackay.com - 30th Jul 202 [3011]

New roles available, bay area CA, level flexible. Relo provided, also flexible during COVID.

This position will assist in developing and applying clinical pharmacology and translational medicine strategies for candidate drug products including from FIH through late stage development and regulatory filing using PK, PD, DMPK, and drug therapeutic principles, and knowledge of drug development processes and regulatory guidance.

A Pharm. D. or PhD in a scientific discipline is required. Post-doctoral work may serve as experience. non-PhDs with demonstrated capabilities and/or significant experience may also be considered. Must be able to demonstrate significant success in technical proficiency, scientific creativity, collaboration with others and independent thought and be able to clearly communicate scientific and technical information both written and oral. Experience working in an regulated environment and experience and understanding of ICH, and GCP is highly desired. Must have hands-on experience with data analysis, non-compartmental and compartmental PK/PD and using data processing software such as Phoenix WinNonlin, R, NONMEM, etc. Good working knowledge of graphing software is also desired.
Contact email address: broseberry@cartermackay.com - 29th Jul 202 [3010]

New role available! Full time, level flexible. Can work remotely to start. email me for more info:

Sr. Scientist/Manager/Associate Director Quantitative Clinical Pharmacology

responsible for providing quantitative clinical pharmacology and pharmacometric deliverables for clinical development assets from phase I-III. The individual will prepare and develop clinical pharmacology plans including dose selections and predictions using mathematical and statistical models to study complex interactions between drugs, patients, and biological systems to understand disease progression and the impact of patient stratification on disease progression.

Primary Responsibilities Include:

Education and Skills Requirements:
Contact email address: telder@stem-sourcing.com - 28th Jul 202 [3009]

The Director level clinical pharmacologist/pharmacokineticist in the Department of Translational Medicine and Early Stage Clinical Development plays a central role in both clinical development and in support of nonclinical development. He/she will represent Clinical Pharmacology function and provide subject matter expertise on cross-functional project teams. He/she will assist in directing the clinical pharmacology development plan, synopsis preparation, clinical phase oversight, and reporting, and provide leadership of a multifunctional study team focused on clinical studies through design, delivery, and reporting, as well as ensuring scientific accountability. He/she will mentor junior and senior level scientists in the department in addition to being an individual contributor.

A core scientific responsibility is ensuring optimal doses and dosage regimens in patients, and as such, the successful candidate must be able to integrate the knowledge of PK/PD, quantitative modeling and simulation, drug development, TK, and nonclinical PK (ADME and DMPK). Working within the clinical development organization, the Director role supports multiple programs through participation on internal project working teams and serves as a liaison between chemistry, life sciences, regulatory and clinical operations.

Essential Areas of Responsibility: The incumbent may design, conduct and/or manage internal and external IND-enabling studies (eg: in vitro and in vivo nonclinical metabolism and PK), design and review clinical pharmacology study protocols and support clinical trials, conduct pharmacokinetic/pharmacodynamic modeling and analyses, and incorporate findings into study report and regulatory documents as well as participate directly in regulatory interactions. A strong background in clinical pharmacology and pharmacokinetics combined with excellent leadership and communications skills are essential in this dynamic role. Clinical pharmacology experience with both small and large molecules in a variety of clinical investigation paradigms (eg: adaptive trial design) is desired. Direct experience with pharmacokinetic/pharmacodynamic modeling, bioanalytical analysis, and nonclinical ADME are desirable attributes. Knowledge of, and immediate experience in the area of CNS and/or oncology therapeutics is desired.

The candidate is expected to be an active contributor to the multi-disciplinary project teams, providing innovative and progressive thinking to projects and where appropriate guidance to other team members. Upon completion of on-boarding, this person will be relied upon to act independently, within a highly matrixed clinical development organization and must have the experience and conviction to provide sound clinical pharmacology related input to the project teams.

Minimum Education & Experience Requirements:

External website https://www.stem-sourcing.com


Contact email address: cornelia.boehnstedt@fu-berlin.de - 16th Jul 202 [3008]

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 & disease profiles of pre-/clinical trials and of therapeutic care by developing and using mathematical & statistical models.

We are currently inviting applications to enrol in 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 associated 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, methodological approaches of modelling & simulation 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, pharmaceutical sciences, mathematics/statistics, bioinformatics, life sciences or medicine. See https://www.PharMetrX.de for further details.

Deadline for applications: 15 September 2020.

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 https://www.PharMetrx.de


Contact email address: Filippos.Kesisoglou@Merck.com - 30th Jun 202 [3007]

Senior Scientist - Biopharmaceutics, Pharmacokinetics

Please see link here:
https://jobs.merck.com/us/en/job/R60517/Senior-Scientist-Biopharmaceut
Our team is looking for a strong candidate for the position of Senior Scientist to support biopharmaceutics assessment across delivery modalities. The successful candidate will be responsible for representing the biopharmaceutics team in drug product development teams, driving the biopharmaceutics strategy, while helping to develop the next generations of physiologically-based modeling and simulation tools.

Primary Responsibilities:
Proactively identifying key biopharmaceutics risks at each stage of drug product development, conducting hypothesis-based assessment employing an integrated approach, driving the development of in vitro-in vivo relationship and preclinical-to-clinical translation in bioperformance of formulations. Developing physiologically-based pharmacokinetic models to facilitate decisions in areas including formulation development, food effect evaluation, in vitro-in vivo correlations and dissolution specification setting. Leading and participating in both internal and external innovation in the fields of biopharmaceutics and modeling.

Education Minimum Requirements:
PhD in Pharmaceutics, Pharmacokinetics or Pharmaceutical Sciences Masters in Pharmaceutics, Pharmacokinetics or Pharmaceutical Sciences with at least 5 years of industry experience.

Required Experience and Skills:
Advanced coursework in pharmacokinetics and understanding of principles of physiologically-based pharmacokinetic modeling. Demonstrated strong proficiency in PK, PK/PD or popPK modeling (e.g., coding in NONMEM, R, MATLAB, Python, Phoenix) Strong influencing and communication skills and demonstrated ability and creativity in solving tough problems. A track record of scientific publications in the field.

Preferred Experience and Skills:
Hands-on experience with physiologically-based pharmacokinetic modeling software (e.g., Simcyp, GastroPlus) is highly desired. Familiarity with advanced use of PK, PK/PD, PBPK/PD models is a plus Experience with applying such models to specialized dosage forms (oral and non-oral extended release, inhaled, others)

External website https://jobs.merck.com/us/en/job/R60517/Senior-Scientist-Biopharmaceut


Contact email address: jchapman@haallc.com - 24th Jun 202 [3006]

Senior Director of Pharmacometrics

Key Responsibilities

Experience Level

External website https://haallc.com/career-opportunities


Contact email address: gobeaun@mmv.org - 19th Jun 202 [3005]

PKPD Translational Medicine Scientist (post-doc fellowship)

JOB PURPOSE

Medicines for Malaria Venture (MMV) is a leading product development partnership (PDP) in the field of antimalarial drug research and development. Its mission is to reduce the burden of malaria in disease-endemic countries by discovering, developing and delivering new, effective and affordable antimalarial drugs.

This 3-year post-doctoral fellowship will provide a PhD graduate with the opportunity to expand their scientific knowledge and skills, to see how pharmacometric approaches (PBPK and PK/PD) are used to speed up the drug development process, from early to late stage and to contribute to the development of innovative modeling approaches.

PRIMARY DUTIES AND RESPONSIBILITIES:

EDUCATION AND EXPERIENCE:

LOCATION: Geneva, Switzerland

MORE INFORMATION AND APPLICATION: on https://www.mmv.org/about-us/work-us/jobs#op-395680-pkpd-translational-medicine-scientist-postdoc-fellowship MMV website

External website https://www.mmv.org/about-us/work-us/jobs#op-395680-pkpd-translational-medicine-scientist-postdoc-fe


Contact email address: cornelius.amberger@merckgroup.com - 3rd Jun 202 [3004]

Associate Scientific Director Discovery NCE DMPK (all genders)

Your role:
We are seeking an experienced Scientific Director to join our Discovery DMPK team Darmstadt. As Scientific Director you will champion and develop new scientific ideas and concepts specifically focused on DMPK-related activities. This will include scientific excellence and validation of in vitro, in vivo and in silico DMPK assays. You will provide support for external opportunity evaluations. The role coaches peers and contribute to maintaining a strategic network within and outside. You will provide scientific input to DMPK strategic goals and contribute to the overall goal of Discovery DMPK of selecting high quality molecules to advance in our pipeline. The Scientific Director will collaborate with the Development DMPK teams to ensure that the right development studies are conducted to manage risk and de-risk identified liabilities. The role will have good understanding of PK/PD models preferentially with hands-on experience in using them to support discovery projects.

You will be DMPK representative in project teams and support projects from concept generation up to selection of development candidates (and beyond when needed). As project representative, you will identify DMPK related key issues in Discovery projects and provide inputs to the design of new molecules to address these issues. The Scientific director will compile DMPK data to predict human PK, and in collaboration with other relevant disciplines (Clinical Pharmacology, Discovery Pharmacology, Safety, Formulation, etc) predict human efficacious dose.

Who you are:

External website https://jobs.vibrantm.com/merck/job/Darmstadt-Scientific-Director-Discovery-NCE-DMPK-(all-genders)-H


Contact email address: telder@stem-sourcing.com - 21st May 202 [3003]

Director/Senior Director Pharmacometrics Quantitative Pharmacology

Requirements:

External website https://www.stem-sourcing.com


Contact email address: telder@stem-sourcing.com - 18th May 202 [3002]

Clinical Pharmacology Scientist

Be a subject matter expert in clinical pharmacology and work in tandem with quantitative pharmacology on strategy for the direction of the group and compounds in the pipeline. Contribute to regulatory documents e.g. IND's, NDA's and BLA's.

This role requires a PhD with at least 2 years of industry experience. Ability to analyze PK/PD population software such as WinNonlin and NONMEM as well as others.

External website https://www.stem-sourcing.com


Last update: Wed 18 Nov 2020 05:09:59 pm


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