PK/PD and Other Jobs

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Contact email address: broseberry@cartermackay.com - 25th Feb 202 [3045]

Please see below role and let me know if interested or have a referral. Position is with an established pharma client. Full time, salary, benefits. Location is MA but can also be remote/WFH with some minimal travel to meet with direct reports from time to time post covid shutdowns.

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 - 24th Feb 202 [3044]

DMPK Scientist

Position & Responsibilities: Our Client is seeking a DMPK Scientist experienced in structural elucidation of oligonucleotides and small molecules by applying analytical techniques including mass spectrometry. S/He will be joining a team of highly motivated and experienced chemists and biologists and contribute to the success of the organization. S/He will be expected to:

Qualifications
Required: All applicants must have authorization to work in the U.S.

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


Contact email address: broseberry@cartermackay.com - 17th Feb 202 [3043]

Associate Director Clinical Pharmacology, NJ
please contract me at broseberry@cartermackay.com for more info. New Associate Director role available with pharma client in NJ. Please email me at broseberry@cartermackay.com for more info The Associate Director, Clinical Pharmacology position will support the clinical pharmacology programs for an expanding portfolio of products across several disease areas. This role will independently execute routine clinical pharmacology tasks with minimum supervision and may include oversight of vendors and/or contractors.

Responsibilities:

Qualifications:
2nd Feb 202 [3042]

Organization Overview:
At Lilly, we serve an extraordinary purpose. We make a difference for people around the global by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism. For more than a century, Eli Lilly and Company has been committed to making life better for our patients and communities. At Lilly, we continuously focus on new and innovative ways to fulfill our extraordinary purpose. Our goal is to add to our diverse team of scientists a teammate passionate about improving the lives of people around the globe. Passion, curiosity, creativity, and persistence are qualities of our research teams. We strive to affect change and deliver results. Do you have the scientific and technical expertise to influence and apply model-informed drug discovery and development? We need you on our team!

Responsibilities:
This is an exciting role responsible for applying quantitative models to the discovery and development of therapeutic drug candidates. We are seeking a modeling and simulation scientist to contribute in a collaborative environment as we use diverse analytical and computational tools to characterize factors influencing the pharmacokinetic and pharmacodynamic properties of a diverse range of therapeutic modalities.

You will have the opportunity to:

Basic Qualifications: Additional Skills/Preferences: Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response. Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

External website https://careers.lilly.com/job/indianapolis/research-scientist-modeling-and-simulation/410/18580266


27th Jan 202 [3041]

Postdoctoral Fellowship in Pharmacokinetics/Pharmacodynamics

UNC Eshelman School of Pharmacy The University of North Carolina at Chapel Hill

A postdoctoral research associate position is available to work on projects focused on characterizing pharmacokinetics/pharmacodynamics in the pediatric population. The project will involve the use of physiologically-based pharmacokinetic (PBPK) and population pharmacokinetic (PopPK) modeling techniques to characterize the effects of age, obesity, and drug-drug interactions in pediatric patients. Requirements: minimum of a PharmD, MD, or PhD with knowledge of pharmacokinetic/pharmacodynamic analyses. Demonstrated software proficiency (e.g., PK-Sim®, NONMEM®, R) is preferred. Excellent communication skills and the ability to work independently and as a member of an interdisciplinary team are essential.

Interested applicants should submit a letter describing personal goals related to the position, Curriculum Vitae, and three professional references at https://unc.peopleadmin.com/postings/187422.

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/187422


Contact email address: telder@stem-sourcing.com - 22nd Jan 202 [3040]

Sr. Scientist DMPK-Must Relocate

Responsibilities
Develop in vitro and preclinical development DMPK strategies Manage DMPK function including both in-house resources and CROs Design, supervise and execute preclinical PK studies Provide discovery project teams with PK/PD expertise Oversee preclinical PK data analysis, interpretation, and reporting Develop IND enabling preclinical DMPK plans to meet regulatory expectations Execution of non-compartmental analysis using Phoenix WinNonlin software Assist in toxicokinetic study design, data analysis, and reporting

Requirements:
PhD in Pharmacokinetics, Drug Metabolism, Pharmaceutical Science, or related discipline with at least 5 years of industry experience Deep expertise in all areas of DMPK Direct hands-on experience and strong trouble shooting skills with in vitro assays, in vivo studies, and Phoenix WinNonlin software Extensive experience with drug development and knowledge of regulatory processes Experienced with FDA regulatory guidance and communications A strong track record of accomplishments Excellent interpersonal, verbal and written communication skills

Preferred:
Knowledge of nucleotide drugs

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


Contact email address: Gaohua.Lu@bms.com - 18th Jan 202 [3039]

Job Description

The Quantitative Clinical Pharmacology (QCP) group within Clinical Pharmacology & Pharmacometrics (CP&P) at Bristol Myers Squibb is searching for a scientist with expertise in Physiologically-Based Pharmacokinetics (PBPK). This scientist will develop and apply PBPK models to address drug-discovery and development questions for small molecules and biologics, in multiple therapeutic areas.

Position Requirements
Ph.D. in Pharmaceutics, Clinical Pharmacology, Toxicology, Biomedical/Chemical Engineering, DMPK or a related field with 5+ years of experience in applying PBPK modeling for DDI and PK predictions. Experience within the pharmaceutical industry or pharmaceutical consulting would be desirable. Candidates with M.S. degree and significantly more industry experience will also be considered. If less than 5 years experience and a Ph.D., you will still be considered but level of position will be commensurate with experience and capabilities. Excellent understanding of the theory and principles in pharmacokinetics and pharmacodynamics, drug metabolism and transporters Ability to learn new areas of biological sciences and build on solid foundation of quantitative skills to develop PBPK models Ability to communicate internally and externally on topics related to Clinical Pharmacology and PBPK is required Ability to keep up-to-date with and propose the implementation of scientific and technological developments in the area of PBPK Hands-on experience with one or more of the modeling software like Simcyp, GastroPlus, PKSim, etc. Experience with general programming and data analysis tools/languages such as R, Matlab, Berkeley Modonna, ADAPT, etc., is desirable Interdisciplinary knowledge of current practices and issues in pharmaceutical R&D in disciplines such as DMPK, clinical pharmacology, bioanalytical, biopharmaceutics, and toxicology is desirable Desire to interact as a modeling and simulation expert with matrix project teams working closely with experts from different functional areas (pre-clinical and clinical)

External website https://careers.bms.com/jobs/R1530007?lang=en-us


14th Jan 202 [3038]

Health Scientist Administrator (Program Officer) Office of Regulatory Affairs Division of Microbiology and Infectious Diseases National Institutes of Health Department of Health and Human Services

The National Institute of Allergy and Infectious Diseases (NIAID), one of the largest Institutes of the National Institutes of Health (NIH), is seeking exceptional applicants with diverse skill sets in pharmacokinetics and pharmacodynamics to serve as a program officer in the Division of Microbiology and Infectious Diseases (DMID). DMID supports extramural research to control and prevent diseases caused by virtually all human infectious agents (except HIV) and directs a program of research grants and contracts in microbiology and infectious diseases.

As a program officer, you will manage or contribute to clinical protocol design, gap analysis for investigational new drug (IND) filing, oversight of bioanalytical method development and validation, evaluation of preliminary pharmacokinetic data, and simulation and modeling of early data in support of follow-up studies. The candidate will serve in the Office of Regulatory Affairs to provide support to ensure the safety and efficacy of target product candidates (vaccines and therapeutics). This position is integral in providing support for strategic development plans for planned clinical trials. These clinical trials involve collaboration across all program branches of DMID, including but not limited to Respiratory Diseases, Bacteriology and Mycology, Parasitology, Virology, Enteric and Hepatic Diseases, Sexually Transmitted Diseases, and the Office of Biodefense, Research Resources, and Translational Research. This program officer position is critical to the division in ensuring that clinical studies are done in a manner that will be acceptable to the FDA and can be used to support product licensure.

Qualifications
Candidates must be U.S. citizens and demonstrate that they have worked independently in planning, organizing, and conducting biomedical behavioral health or health-related research as well as served effectively in research program administration in these fields.

Clinical pharmacokineticists with clinical and regulatory expertise in clinical drug and/or vaccine development and drug and vaccine safety are preferred.

Candidates with the following experience and skills are desired:

To Apply Visit USAJobs.gov and access the health scientist administrator/program officer vacancy announcements NIH-GR-DH-21-10999306 (U.S. citizens) and/or NIH-GR-DH-21-10999307 (status candidates) from January 18 – 27, 2021.

For more information about health scientist administrator positions and qualification requirements, visit Global Recruitment: Recruiting for all of NIH!

Visit NIAID Careers for more information about working in NIAID’s dynamic atmosphere!

HHS, NIH, and NIAID are equal opportunity employers dedicated to diversity, equity, and inclusion.

External website https://www.usajobs.gov/GetJob/ViewDetails/589238100


11th Jan 202 [3037]

UNC/GSK Postdoctoral Fellowship in Pharmacokinetics/Pharmacodynamics

The UNC Eshelman School of Pharmacy and GlaxoSmithKline (GSK) offers a two-year postdoctoral fellowship in pharmacokinetics/pharmacodynamics (PK/PD). The fellowship emphasizes coursework and hands-on experience focused on the application of population and physiologically-based PK/PD modeling and simulation techniques to guide drug development. Fellows spend their first year at the University of North Carolina at Chapel Hill, and the second year at GSK research facilities.

At the completion of the Fellowship, the post-doctoral fellow will be able to:

Requirements: minimum of a PharmD, MD, or PhD with knowledge of PK/PD analyses. Excellent communication skills and ability to work independently as well as a member of an interdisciplinary team are essential. Additional information is available through this web site: https://pharmacy.unc.edu/education/fellowships/pharmacokinetics-pharmacodynamics-fellowship/. Interested applicants can apply through this web link: http://pharmacydpetfellowships.web.unc.edu/.

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 http://pharmacydpetfellowships.web.unc.edu/


Contact email address: telder@stem-sourcing.com - 11th Jan 202 [3035]

*REMOTE*Director/Sr. Director Clinical Pharmacology/Clinical PK

Our Client is a clinical stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, This Company’s therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes.

This Company is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver, lung, and solid tumors with a promising pipeline of preclinical candidates.

The Position
This Company seeks a Sr. Director level, Clinical PK/PD specialist to join its Clinical Pharmacology team. This individual will report into This Company’s VP, Clinical Pharmacology/DMPK.

Responsibilities

Requirements: Preferred:

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


Contact email address: vkeyser@aligos.com - 28th Dec 202 [3034]

Principal Research Scientist - DPMK

Aligos Therapeutics, Inc. is a biotechnology company located in South San Francisco, California that is developing novel medicines to treat liver diseases in virology, inflammation/fibrosis and oncology. Aligos is pursuing the development of both oligonucleotide-based and small molecule therapeutics, each addressing major commercial market opportunities.
At Aligos, our science is the key to our success with the ultimate goal of improving patients' quality of life. Our pipeline of developing novel compounds and investigative therapies reflects our commitment to bring innovative products to patients with unmet needs in the area of liver diseases. This is an exciting opportunity to become an employee a high energy Research and Development company. We are looking for an enthusiastic person who understands and appreciates the entrepreneurial environment and who is willing to do what it takes to contribute to the success of the company.

This position is responsible for providing DMPK expertise for new chemical entities, small molecule and oligonucleotides, as a project representative on multi-disciplinary drug discovery and development teams. The candidate will work closely with nonclinical discovery scientist, clinicians and cross-functional project team members. Responsibilities include guiding discovery project teams for candidate selection, developing and driving DMPK strategies for lead optimization and solving ADME-related issue, designing and interpreting in vitro and in vivo DMPK studies. Responsibilities also includes determining PK parameters for nonclinical studies using WinNonlin and assisting with the application of modeling approaches (in silico, PK, PBPK) to support human pharmacokinetics and dose predictions, quantitative risk assessment of drug-drug interactions, monitoring of GLP bioanalysis, and CRO management. To support GLP toxicology and clinical studies, this position is responsible for monitoring methods development, validation, sample analysis and reviewing and approving reports. The candidate will be required to generate, analyze and present data, both orally and as written reports, author and review various regulatory documents and interact with worldwide regulatory authorities.
Qualifications and requirements:

External website https://www.linkedin.com/careersite/aligos


Contact email address: telder@stem-sourcing.com - 17th Dec 202 [3033]

Associate DIrector/Director Quantitative Pharmacology

KEY RESPONSIBILITIES

QUALIFICATIONS

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


Contact email address: christine.ahlstrom@astrazeneca.com - 11th Dec 202 [3032]

Are you an expert in mathematical modelling? Would you like to apply your expertise in a company that is accelerating innovative science and turns ideas into life changing medicines? Join us to be part of the development of future treatments of Cardiovascular, Renal and Metabolic diseases!

Working at AstraZeneca means being entrepreneurial, thinking big and working together to make the impossible a reality. We are now recruiting a highly skilled and passionate scientist with expertise in mathematical modelling, preferably applied in the field of pharmacokinetics-pharmacodynamics(PKPD), to join the Modelling & Simulation team within the EarlyCardiovascular, Renal and Metabolism (CVRM) therapeutic area at AstraZeneca. The position is placed at AstraZeneca’s dynamic R&D site in Gothenburg, Sweden.

Early CVRM is one of the three main therapeutic research areas within AstraZeneca which deliver candidate drugs into late-stage clinical development. Early CVRM is a global function with research units in Gaithersburg, US, Cambridge, UK and Gothenburg, Sweden. The Modelling & Simulation team is part of the Drug, Metabolism and Pharmacokinetics (DMPK) department and based in AstraZeneca’s world-class R&D center in Gothenburg Sweden. DMPK interacts with other functions in supporting Early CVRM projects all along the value chain, from target selection all the way to market launch and Life cycle management.

What you’ll do
With a true passion for science you will support our portfolio within the CVRM disease area. You will deliver translational quantitative/PKPD input for a broad range of drug modalities from target identification to life-cycle management. The position can be at Senior Scientist or Associate Principal Scientist level depending on the experience of the successful candidate.

Responsibilities includes:

External website https://careers.astrazeneca.com/job/gothenburg/preclinical-and-translational-pk-and-pkpd-scientist/7


Contact email address: robin.michelet@fu-berlin.de - 10th Dec 202 [3031]

The Department of Clinical Pharmacy and Biochemistry of the Institute of Pharmacy at the Freie Universitaet Berlin is currently looking for a:

Postdoctoral Research Fellow (m/f/d)

We are an interdisciplinary, international, research-oriented group applying high scientific standards and innovative methodologies with the ultimate aim to foster the rational use of medicines while empowering young scientists to perform clinically relevant research (http://www.clinical-pharmacy.eu/).

Our group is grounded on two research pillars: (1) Bioanalysis, microdialysis, cell culture, and (2) Pharmacometric (data) analysis. As key feature, the two pillars are bridged, as our pharmacometric projects are based on in vivo or in vitro data obtained by the experimental research pillar, while innovative dynamic in vitro systems utilise modelling and simulation approaches. In addition, many of our projects are realised as parts of clinical studies. Typically, our research is embedded in consortia at a national and international level (EU, global).

We are looking for a full-time postdoctoral fellow in the field of optimising drug therapy and drug development by applying innovative translational modelling and simulation techniques to join our research group for a period of at least 2 years; extension to 5 years is possible. To be eligible for the positions, a PhD and a strong record in the pharmacometric research area is needed. Additionally, experience in either or (i) evaluating pharmacokinetic, pharmacodynamic or systems pharmacology data and pharmacometric analysis with NONMEM, R or similar pharmacometric software, (ii) Bayesian analysis using STAN or similar platforms, or (iii) one of our experimental platforms (LC/MS-MS, microdialysis, bacterial infection models, in vitro metabolism) is required. The positions also offer supervision of PhD and Master/Diploma students.

Applications in English should include a letter of motivation along with a description of research interests and relevant qualifications for the position. In addition, a curriculum vitae including a list of publications and names/email addresses of 2-3 referees should be provided. Please submit your application to: charlotte.kloft@fu-berlin.de and robin.michelet@fu-berlin.de

Project summary
Currently, respiratory tract infections represent the third leading cause of death worldwide (about 3 million deaths per year). Bacterial pneumonia (either community-or hospital-acquired) is a leading cause of morbidity, quality-adjusted life year loss, and mortality in children, adults, and the elderly. In Europe, pneumonia costs €10 billion each year. Although antibiotics have transformed the management and treatment of bacterial pneumonia, their effectiveness is declining -because of antimicrobial resistance (AMR). The World Health Organization (WHO) estimates that bacterial infections due to AMR will outcompete any cause of death by 2050, meaning that it is crucial to develop new strategies to improve antibacterial treatment. In 2017, the WHO defined a priority list of bacteria for which new antibacterial therapies are urgently needed; it includes the major pneumonia-causing pathogens Pseudomonas aeruginosa, Klebsiella pneumoniae, and Streptococcus pneumonia.

The FAIR project (European grant H2020 -call SC1-BHC-14-2019) proposes a unique approach: aerosol delivery of an immunomodulatory protein (by nebulization), achieving direct release into the airways, prompting innate immunity activation in the lungs and preventing systemic immune activation.

Please visit our website, https://www.clinical-pharmacy.eu for more information. The project is included in a research grant program “FAIR” (https://fair-flagellin.eu/) gathering European teams and coordinated by J.C Sirard, Inserm,Lille, France.

Job profile

Qualification profile
Requirements: Assets: We are looking forward to your application!

External website https://fair-flagellin.eu/news


Contact email address: telder@stem-sourcing.com - 3rd Dec 202 [3030]

PK/PD Modeler-Senior Scientist-REMOTE

Our new favorite client is looking for a strong modeler. Phoenix Winonlin, pop pk, NONMEM experience is what is needed. Phd with 2-3 years of experience for MS with 7-10 years of experience would be great. The position can be remote or it can be a hybrid in the future. This is an exciting role at a growing company. Be part of a winning team with great people and great science!

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


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


Last update: Thu 25 Feb 2021 04:10:47 pm


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