PK/PD and Other Jobs

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Contact email address: patrick.augustijns@kuleuven.be - 21st Jan 202 [2980]

KU Leuven invites applications for a full-time tenured academic position in Pharmacometrics at the Department of Pharmaceutical and Pharmacological Sciences. We are looking for a dynamic and motivated individual (m/f) with an excellent research record and extensive experience in this field. The Department of Pharmaceutical and Pharmacological Sciences includes all medicines related disciplines from validation of a target to the safe use of a drug by the patient. While modelling and simulation are currently applied within several research units of the department, there is a clear need for the implementation of expertise and vision in the field of model-based drug development.

External website https://lnkd.in/daEUXJw


Contact email address: broseberry@cartermackay.com - 17th Jan 202 [2979]

Senior Director CLinical Pharmacology (2 roles, one in the bay area and one in MA) inquiries and interest to: broseberry@cartermackay.com

The Senior Director of Clinical Pharmacology is expected to lead a team of clinical pharmacologists and provide technical and strategic leadership on issues related to clinical pharmacology and pharmacokinetics and pharmacodynamics (PK/PD) from the discovery stage up to the post marketing support (PMS) stage. The overall responsibilities include providing Clinical and non-Clinical Pharmacology functional line leadership and oversight in designing and executing, within the regulatory framework, non-clinical DMPK and toxicokinetic (TK) studies during the discovery phase, and FIH, POC, Phase 1 to 4 studies during the clinical development phase for R&D projects. The responsibilities also include managing company’s technical and strategic needs for conducting in-licensing activities. The incumbent is responsible for ensuring Clinical Pharmacology support and is expected to actively participate in the key decisions at the R&D governance milestones. The incumbent is expected to have hands-on knowledge and ability to strategically guide and contribute to model and simulation based quantitative assessments. At the non-clinical stage the incumbent is responsible for providing leadership on key milestones up to IND filing by collaborating with toxicology and biomarker functions to enable selection of dose/regimen for FIH studies for all research programs. At the clinical stage the incumbent is responsible for authoring and strategizing clinical pharmacology development plans, identifying Phase 2/3 dose regimens by collaborating with Pharmacometrics and other disciplines, providing strategic ownership and direction to the authoring and review of protocols, reports and integrated summaries submitted to the regulatory authorities and interacting with the regulatory authorities. The responsibilities also include managing the department resources and budgets at a therapeutic area level. At the enterprise level, the expectation is to provide leadership in functional compliance and cross-functional collaboration on companywide initiatives related to productivity, innovation or efficiency.

Principal Responsibilities

Qualifications
Contact email address: telder@stem-sourcing.com - 7th Jan 202 [2978]

Associate/Director, Clinical Pharmacology/Pharmacometrician

The Director, Clinical Pharmacology/Pharmacometrics will join a dedicated team of clinical development professionals and be responsible for all aspects of clinical pharmacology with focus on PKPD, population PKPD and regulatory interactions. They will be instrumental in dose selection and dose optimization efforts through analyses of PKPD data. They will be interfacing with various groups internally and externally with CROs and alliance partners to ensure proper support for programs and studies. The individual in this role will work with minimal supervision and participate in KOL and regulatory meetings. They will provide strategic and scientific direction and be diligent in delivery of key CP project goals.

Responsibilities: Lead pharmacometric aspects of clinical development plans across multiple projects. Hands on pharmacometric modeling, including exposure-response, disease modeling, and population modeling. Serve as a primary source of scientific support for the design, analysis, reporting, and presentation of pharmacokinetic and pharmacodynamic results from clinical studies. Contribute to clinical study designs including first-in-human, human mass balance, bioavailability and/or bioequivalence and drug-drug interaction studies. Develop submission ready summaries of modeling results and interpretations for regulatory documents (IND, NDA, IB, etc). Familiarity of FDA and EMA, and ICH guidance documents including GXp regulations on current practices in the areas of POPPK, PKPD, ADME and clinical pharmacology. Responsible for contributing pharmacometric and clinical pharmacology components of regulatory submissions and responses to questions from regulatory agencies. Oversight of M&S CROs and consultant relationships to ensure capacity to respond to program needs at all stages of development Candidate is expected to work independently with minimal supervision. Mentor colleagues in the department. Strong communication, organizational and interpersonal skills, and ability to manage projects and team members in a matrix environment.

Basic Qualifications: PhD. in pharmacokinetics or related discipline with 5 to 8 years of relevant industrial experience Experience (1-2 years) demonstrating regulatory submission with NDA and INDs and responses to regulatory clinical pharmacology/pharmacometric questions. Preferred Qualifications: Strong scientific background in pharmacokinetics, pharmacodynamics and drug disposition sciences Experience in population PK, PKPD, M&S utilizing software such as NONMEM, Monolix, R, Gastroplus/Simcyp/PKSim is desirable. Experience working with external vendors and CROs. Problem solving and organizational skills with attention to detail. Strong team player and strong motivational skills.

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


Contact email address: yingfeili803@msn.com - 12th Dec 201 [2977]

Novartis Analytics Internships 2020

Location: East Hanover, NJ; Cambridge, MA Number of Positions: Multiple Type of Student: Graduate, PhD Deadline for Applying: January 31, 2020

At Novartis, we are reimagining medicine to improve and extend people’s lives. We have one of the most diverse product pipelines in the pharmaceutical industry and performance-driven professionals are bringing innovative medicines to life.

The department of biostatistics and pharmacometrics at Novartis will have multiple internship positions available for approximately 12 weeks in 2020 (May to August; dates flexible).

Job Description:
Interns will work on statistics, pharmacometrics or data science projects to design and analyze clinical trials and/or perform relevant quantitative research under the guidance of experienced quantitative scientists. Various real-world problems will give interns hands-on exposure to the early and late phases of drug development across different therapeutic areas, including oncology, cardiology, immunology, neurology, ophthalmology, and respiratory care. Potential topics include machine learning (e.g. deep learning), survival analyses, causal inference, Bayesian statistics, disease progression modeling, and/or PK/PD modeling. Interns will also attend seminars and other activities to enhance their understanding of the drug development process. There will be opportunities for interns to present their project results to quantitative scientists and other key stakeholders.

Requirement:
Candidates must be enrolled in a graduate – level program working toward a PhD in biostatistics, statistics, pharmacometrics, engineering, mathematics, or a related quantitative discipline and have completed at least 1.5 years of course work. In addition, candidates must be authorized to work in the United States.
Competitive candidates must have the following skills:

To Apply: Please send your cover letter and CV to internships.analytics@novartis.com
10th Dec 201 [2976]

Dear Colleagues,

The Modelling and simulation group at Ablynx, a Sanofi Company, is looking for an experienced pharmacometrician to join our team. The position is based in Ghent, Belgium.

Preferred Background: PhD in PK-PD or Pharmacometrics with Drug Development Experience.

Interested colleagues can apply via the link below https://sanofi.wd3.myworkdayjobs.com/SanofiCareers/job/Gent/ASSOCIATE-PRINCIPAL-SCIENTIST-M-F_R2525439-2

Ablynx, a Sanofi company, is engaged in the development of Nanobodies, proprietary therapeutic proteins based on single-domain antibody fragments, which combine the advantages of conventional antibody drugs with some of the features of small-molecule drugs. Ablynx advances a portfolio of Nanobody-based therapeutic programs in several major disease areas, including inflammation, haematology, immuno-oncology and oncology. www.ablynx.com This position requires substantial experience and expertise, as it will also entail mentoring and guidance of more junior PK/PD modelers and members of collaborating departments. At the project level, the individual will be a member of the translational medicine subteam and in specific cases may lead this subteam and participate on the project core team. The position is located in Belgium.

Responsibilities Main duties

Major challenges and opportunities Requirements Basic Qualifications
Contact email address: karley.yeoman@astrazeneca.com - 25th Nov 201 [2974]

At AstraZeneca we turn ideas into life changing medicines. Working here means being entrepreneurial, thinking big and working together to make the impossible into reality. We're focused on the potential of science to address the unmet needs of patients around the world. We commit to those areas where we believe we can change the course of medicine and bring new ideas to life.

As a Clinical/Senior Clinical Pharmacometrician, you will be responsible for population PK, PKPD, exposure-response, disease modelling, and simulations in all clinical development phases in oncology, with special emphasis on biologics . You will have the opportunity to contribute to state-of-the-art modelling and simulation (M&S) approaches. The desired candidate will have strong quantitative skills to influence designs and conduct decision-making at the project level.

Main duties and responsibilities:

Essential Requirements: Desirable Requirements:

External website https://astrazeneca.wd3.myworkdayjobs.com/en-US/Careers/job/UK---Cambridge/Clinical-Senior-Clinical--Pharmacometrician_R-065009-1


Contact email address: catia.marzolini@usb.ch - 22nd Nov 201 [2973]

PhD thesis in physiologically based pharmacokinetic modeling of long-acting injectable antiretroviral drugs: Basel, Switzerland

A fully funded PhD position (100%) is available in the Division of Infectious Diseases & Hospital Epidemiology at the University Hospital of Basel. The 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 (i.e. physicochemical characteristics, intrinsic clearance, and intestinal permeability) 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.

You are a highly motivated young scientist with an above-average degree (MSc or equivalent) in pharmacy, natural science or mathematics. In addition, you have knowledge about relevant pharmacological concept. Experience in modelling will be an advantage

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/ presentations at conferences, three academic references as well as a letter of motivation to: Prof. C. Marzolini: catia.marzolini@usb.ch and F. Stader: felix.stader@unibas.ch Applications will be considered until December 31, 2019. The position is available from April 2020.

Please note that there will be no follow-up correspondence for applications that do not fulfill the position requirements.


Contact email address: mehvar@chapman.edu - 19th Nov 201 [2972]

Postdoctoral Research Fellow in Pharmacokinetics/Pharmacodynamics/Drug Metabolism

A Post-doctoral position is available in the Department of Biomedical & Pharmaceutical Sciences at Chapman University School of Pharmacy in Irvine, California. The specific research includes the use of animal models to study the effects of liver diseases on the transporter- and/or cytochrome P450-mediated hepatobiliary and brain disposition of drugs. Candidates with a Ph.D. degree in Pharmaceutical Sciences with interest in the areas of pharmacology/ pharmacokinetics/drug disposition/drug metabolism will be considered. Additionally, the position requires prior experience with surgical procedures in rodents and analytical methods, such as LC/MS/MS, demonstrated by strong peer-reviewed publications. Excellent oral and written communication skills and the ability to work independently or as part of an interdisciplinary team are essential. The successful candidate will work in a new research facility, which is equipped with state-of-the-art research equipment.

Qualified applicants should submit a curriculum vitae, a summary of research interests, and names/titles and contact information of three references electronically to Dr. Reza Mehvar (mehvar@chapman.edu). Review of applications starts immediately and will continue until the position is filled.

Chapman University is an Equal Opportunity Employer, committed to providing career opportunities to all people, without regard to race, color, religion, sex, age, national origin, sexual orientation, disability, or veteran status.

External website https://www.chapman.edu/our-faculty/reza-mehvar


Contact email address: broseberry@cartermackay.com - 7th Nov 201 [2971]

Sr. Scientist PBPK and clinical pharmacology--NJ please email me with interest and questions at broseberry@cartermackay.com The Senior Scientist will collaborate with team members to identify and define mechanisms of action, biomarkers and new drug targets. They will help design clinical pharmacology trials and selecting pharmacokinetic (PK)/pharmacodynamic (PD) /biomarker assessments throughout development, develop physiologically-based pharmacokinetic (PB-PK) models, evaluate new formulations effect on PK. Will conduct PK/PD analysis and reporting, contribute relevant sections to regulatory filings, work with pharmacometricians to develop PK/PD models and contribute to commercial strategies.

Key responsibilities

Qualifications
Contact email address: ester.lori@basilea.com - 4th Nov 201 [2970]

Basilea Pharmaceutica Ltd. is a commercial stage biopharmaceutical company, headquartered in the heart of the life sciences hub of Basel, Switzerland. We are an innovative and multinational team of 225 employees worldwide and committed to discovering, developing and bringing to market medicines that make a clear difference to the lives of patients. Our activities are focused on the therapeutic areas of oncology and anti-infectives, with two commercialized drugs in our portfolio (Cresemba(R) and Zevtera(R)).

For our headquarter in Basel we are currently looking for a Senior Clinical Pharmacologist (M/F) to join our team

Your tasks

Your profile Basilea is committed to putting people first. In addition to competitive remuneration, we offer the opportunity to work on interesting, cross-functional projects in an engaging working environment. We strongly believe that every employee can make an impact and is vital to our success.
If you wish to become part of a company that strives to make a difference to the lives of patients worldwide, we are looking forward to receiving your application via our careers portal.

External website https://jobs.basilea.com/Senior-Clinical-Pharmacologist-MF-eng-j440.html


Contact email address: daniel.scotcher@manchester.ac.uk - 16th Oct 201 [2968]

PhD Studentship at University of Manchester (MRC DTP): Model-driven optimization of drug therapy and individualisation of healthcare in chronic kidney disease

Funding: MRC DTP studentship funding for tuition fees and stipend for 3.5 years

Supervisors: Dr Aleksandra Galetin (PI), Dr Daniel Scotcher

Background: Chronic kidney disease (CKD) is associated with increasing age, as approximately 50% of individuals over 75 years are affected by some degree of kidney disease. The ageing population is also more likely to have common comorbidities (cardiovascular diseases, diabetes) and be prescribed multiple medications, and hence the risk of potential drug-drug interactions (DDI) in patients with renal impairment is high. However, high percentage of drug product labels lack any evidence-based recommendations for dosage adjustment in patients with advanced renal impairment. Therefore, CKD patients are susceptible to adverse side effects of drugs (e.g., drug induced kidney injury) and increased risk of inappropriate dosing. Model-based precision dosing is an approach for determining suitable dose adjustments using in silico tools (e.g., physiologically-based pharmacokinetic (PBPK) models) to improve drug efficacy and safety in specific populations such as CKD.

Project Aims: This project aims to develop quantitative translational tools to facilitate individualized healthcare in CKD and provide guidance to clinicians for rational dose adjustment when direct evidence in this patient population is lacking. CKD patients exhibit impaired active tubular secretion and therefore reduced renal excretion mediated via renal transporters. PBPK modelling in this project will implement different disease-related perturbations of active secretion and focus on selected renal transporter probes with reported nephrotoxicity/clinical data in patients with advanced CKD. The modelling and simulation will be supported by in vitro studies where activity of selected renal transporters (e.g., OAT1) will be investigated under different experimental conditions mimicking CKD. Uptake of selected drugs (same as used for modelling purposes) in proximal tubule cells will be investigated with cells exposed to plasma from healthy and subjects with severe CKD (to be obtained from collaborator Prof. Philip Kalra, Salford Royal Hospital, Manchester). Functional transporter studies will be supported by LC-MS proteomic measurements of the transporter expression in different experimental conditions and related to protein expression in vivo.

Training The successful applicant will receive state-of-the-art training to build a broad and transferable skillset including in vitro cellular assays, proteomics analysis and PBPK modelling. Active participation in the Centre for Applied Pharmacokinetic Research (CAPKR), University of Manchester will provide opportunity to interact with a multi-disciplinary research team. Student will be encouraged to attend international conferences to promote work and build network as an independent researcher, as well as publish in highly-cited peer reviewed journals. The proposed inter-disciplinary and model-driven approach has strong foundations and builds upon previous and ongoing research in CAPKR.

Eligibility: UK/EU nationals only

Applications: Enquiries about the project should be sent to Dr Aleksandra Galetin: aleksandra.galetin@manchester.ac.uk

Applications should be made via the University of Manchester website: https://www.bmh.manchester.ac.uk/study/research/mrc-dtp/apply/

External website https://www.bmh.manchester.ac.uk/study/research/mrc-dtp/apply/


13th Sep 201 [2967]

Scientific Director Discovery NCE DMPK (all genders)

Your role:

We are seeking an experienced Scientific Director to join our Discovery DMPK team Darmstadt Germany.

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://www.merckgroup.com/en/careers/jobs/193786.html


26th Aug 201 [2963]

Summary The Director of the Preclinical Pharmacokinetics and Pharmacodynamics group will be responsible for leading a group of scientists responsible for the design, pharmacokinetic analysis, and reporting of non-clinical animal pharmacokinetic, toxicokinetic, and ADME studies. The Director will be responsible for the oversight of external pharmacokinetic studies, establish deliverables, maintain timelines, and foster open communication with and between the Project Teams, Preclinical Operations, members of the Preclinical PK/PD group, Pharmacometrics, Toxicology and Functional Heads. Responsibilities will also include reviewing and providing content and subject matter expertise relating to preclinical pharmacokinetics, toxicokinetics and ADME sections of regulatory documents to include: INDs, BLAs and other regulatory submissions and responses, as needed.

Responsibilities

Requirements

External website https://careers.regeneron.com/job/REGEA0026306922/Director-Preclinical-Pharmacokinetics-and-Pharmaco


Contact email address: christopher.kohl@idorsia.com - 22nd Aug 201 [2961]

About Idorsia Pharmaceuticals Ltd

Idorsia Ltd is reaching out for more - We have more ideas, we see more opportunities and we want to help more patients.

In order to achieve this, we will develop Idorsia into one of Europe’s leading biopharmaceutical company, with a strong scientific core.

Headquartered in Switzerland - a European biotech hub - Idorsia is specialized in the discovery and development of small molecules, to transform the horizon of therapeutic options. Idorsia has a broad portfolio of innovative drugs in the pipeline, an experienced team, a fully-functional research center, and a strong balance sheet – the ideal constellation to bringing R&D efforts to business success.

Idorsia was listed on the SIX Swiss Exchange (ticker symbol: IDIA) in June 2017 and has over 600 highly qualified specialists dedicated to realizing our ambitious targets. ob Responsibilities

Providing quantitative pharmacokinetic and pharmacodynamic modeling and simulation expertise to pre-clinical project and Life cycle teams Applying quantitative PK/PD modeling and simulation to inform pre-clinical candidate selection Being a champion and advocate for pharmacometrics within the company Analyzing, interpreting and reporting pharmacokinetic and pharmacodynamic data from pre-clinical studies Performing PK/PD simulations and predicting pre-clinical and clinical PK from nonclinical data as appropriate Collaborating, mentoring and guiding other DMPK team members with pharmacometric support on their projects Interacting cross-functionally with other departments including Medical Organization, Toxicology, Formulation and Discovery Preparing and/or reviewing PK, PK/PD components of internal documents, briefing books and regulatory submission documents (e.g. IND, NDA, IB) Actively preparing, reviewing and publishing scientific papers and abstracts Representing the DMPK line on project teams spanning Discovery to NDA

Candidate’s Requirements

What Idorsia offers Work Location: Allschwil
Country: Switzerland
Business Area: Drug Discovery - Pharmacology DMPK
Schedule: Fulltime
Job Type: Permanent
Job ID: 1256 Please apply exclusively via the career portal on our home page.

External website https://careers.idorsia.com


Contact email address: telder@stem-sourcing.com - 2nd Aug 201 [2960]

URGENT CLIN PHARM M/S QSP NEED: Director level roles. Individual contributor or roles that require the management, training and mentoring of junior scientists. Progress your career in a growing environment that is on the cutting edge. Openings in small molecule, gene therapy and antibodies

Director, Clinical Pharmacology

Job Description

Company is looking for a Clinical Pharmacology leader to join the team in Boston, MA. The Clinical Pharmacology leader is a highly scientific role, supporting multiple facets of Clinical Pharmacology, including study design, PK and PK/PD analyses, and overall drug development support. He/She will complete assigned work in a resourceful, self-sufficient manner and will be able to create alternative approaches to achieve desired results if needed. The candidate will have an excellent knowledge of Clinical Pharmacology principles, such as PK, PK/PD, drug metabolism, and DDI, as well as a good understanding of related disciplines such as pharmaceutical development, regulatory, and overall drug development.

Key Responsibilities:

Minimum Qualifications

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


2nd Aug 201 [2959]

Pharmacometrician - Brisbane, Australia

The Position

Model Answers R&D Pty Ltd is seeking applications for a pharmacometrician to join their team in Brisbane, Australia. The successful applicant will work in an inspiring group that provides a range of quantitative solutions to a global client network. The position would suite a highly motivated individual with a desire to continuously learn, and looking for a challenging opportunity to facilitate successful drug development. Applicants should have excellent time management and communication skills with a background in pharmacokinetic / pharmacodynamic data analysis. Applicants should also have programming experience in SAS, R or SPlus, and demonstrated modelling experience using NONMEM or equivalent software.

Essential Skills:

We will train, support and assist you in: The Location and Company

All positions are located in the central business district of Brisbane. Model Answers R and D Pty Ltd is a growing consultancy business dedicated to helping pharmaceutical and biotech companies make successful drug development decisions. Employees, shareholders and equity stake holders are expected to be upstanding members of the community, who have an inbuilt desire to develop, create, and innovate. Opinions and ideas are welcomed, resulting in a dynamic business, led by those who work in the business.

Interested applicants should apply via recruitment@model-a.com.au or refer to our website (www.model-a.com.au) for further information. Applications close 26 August 2019.

External website https://www.model-a.com.au


Last update: Tue 21 Jan 2020 07:43:14 pm


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