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
- Strategize, formulate and execute on modeling and simulation strategy for clinical projects with ability to independently plan, design, analyze, interpret and report PKPD modeling results for internal decision making and regulatory filings
- Train, mentor and grow pharmacometrics team members in modeling and simulation skills.
- Responsible for identification of dosing regimen and optimization of dosing for products
- Collaborate and influence decision making pertaining to dosing and clinical trial design on project teams
- Strategize, collaborate cross-functionally with other departments and provide modeling and simulation support
- Formulate pharmacometric strategy and responses to regulatory health authority inquiries on PK, PK/PD, dosing and clinical pharmacology related issues. Represent pharmacometrics at regulatory meetings.
- Enhance role and visibility of pharmacometrics internally within the company and showcase expertise through publications in peer reviewed journals and presentations at scientific meetings
Requirements/Qualifications
- Candidate with a Ph.D (or equivalent) degree in pharmacokinetics, biopharmaceutics or related field
- At least 10 years of pharmacometrics experience in pharmaceutical industry or regulatory agency. Should have hands-on experience and an expert in NONMEM, S-plus, R-, SAS and WinNonlin and should be intimately familiar with the drug development process. Be a team player and a strong cross-functional contributor and partner.
Special Skills/Abilities
- Candidate should possess good understanding of pharmacokinetic and pharmacodynamic principles and have extensive experience in quantitative population PK/PD modeling and simulation using NONMEM
- Candidate should have experience in clinical endpoint, disease progression and mechanistic modeling
- Strong managerial skills with proven record of mentoring and advancing a pharmacometric group
- Candidate should have experience writing clinical pharmacology sections of NDA/MAA and preparation of pharmacometric reports to support regulatory filings
- Strong written and oral communication skills
- Team player with strong interpersonal skills
- Ability to strategize, influence, advance and implement model based drug development. Formulate strategy and engage with regulatory authorities on development proposals particularly around dose selection. Showcase value of modeling and simulation through informed decision making.
- Independent contributor who is able to multi-task and prioritize with minimal supervision. Provide mentoring, strategic and planning support and train pharmacometrics team members in advanced pharmacometric skills. Motivated to promote role of pharmacometrics across the company in a personable, result-oriented and collaborative manner.
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.- Work with lab-based scientists to design and analyze data generated with in vitro and In vivo PK/PD models to be used in support of clinical exposure targets
- Utilize in vivo allometric and/or in vitro intrinsic clearance data to predict human PK and analysis with PK/PD understanding to inform human dose projections
- Construct population PK model analyses utilizing clinical trial PK and demographic data to be used in support of Monte Carlo simulation and probability of target attainment assessments.
- Conduct modeling and simulation utilizing PK predictions, PK/PD understanding, and data available in the literature
- Assemble posters and presentations for external disclosure including conference attendance
- PhD + 2 to 3 years pharmaceutical research experience or BS/MS with 10+ years of experience
- +5 years of experience in DMPK, PK/PD, or quantitative pharmacology
- Established publication record
- Working knowledge of pharmacokinetic modeling including non-compartmental analysis, non-linear modeling, Population pharmacokinetics / pharmacodynamics (PK/PD) modeling
- Experience with translational mechanism-based modeling, Monte Carlo simulations and physiologically based PK modeling preferred
- Proficiency with modeling software packages NONMEM, Phoenix WinNonlin, MATLAB SimBiology and non-linear mixed effect models/statistical software
- Excellent communication/presentation/Power point skills are required
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
- In your role, you are in charge of designing, contracting, interpreting and reporting laboratory studies in compliance with all applicable regulations and guidelines (e.g. Good Laboratory Practice (GLP), Animal Welfare, Regulatory requirement, Pharmacovigilance) with focus on pharmacokinetic (PK), pharmacokinetic/pharmacodynamic (PK/PD), bioequivalence (BE), and relative bioavailability (RBA) studies.
- You perform PK/PD evaluations and data analysis using Phoenix WinNonlin. As a technical expert, you critically evaluate study results and present clear recommendations to global project teams
- As a project team member, you represent Drug Safety and DMPK in international, multidisciplinary research and development teams and provide strategic input for the Target Product Profile (TPP) and the global development of pharmaceutical products.
- Furthermore, as a subject matter expert you provide technical content for answering questions from regulatory authorities, external research collaborations with academic and industrial partners as well as the compilation of registration dossiers for European and US registrations, expert statements, and reports for regulatory purposes.
- Doctoral degree (e.g. PhD, DVM) in life science with several years of industry experience in relevant field
- Advanced knowledge in pharmacokinetics, assessments of PK/PD relationships, bioequivalence (BE) and/or relative bioavailability (RBA) studies
- Proficiency in data analysis and applying pharmacokinetic software (e.g. Phoenix WinNonlin)
- Experience with in vivo laboratory studies and/or scientific research required including protocol development, study design, processing, analysis and collation of data In-depth understanding of risk assessment and analysis as well as risk mitigation strategies
- Exceptional planning and organizational skills
- Strong team work and collaboration skills
- Excellent written and oral communication skills in English (German is of advantage)
- Willingness to travel
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:
- Provide PBPK/PKPD modeling expertise to preclinical and clinical projects for antimalarial treatment or chemoprevention
- Depending on the expertise of the applicant, the job could focus on one of the following areas or include both:/li>
- PK/PD analyses of non-clinical and clinical studies, especially of combinations of new antimalarial compounds
- Development and application of PBPK modelling: PK DDI assessment between antimalarial drugs used in a combination and between antimalarial drugs and other treatment; improve PK predictions in African children; predict the effect of malaria on PK, predict PK in pregnant and lactating women
- Publish high quality research articles
- Attend selected conferences for training, giving presentations and posters, representing MMV
EDUCATION AND EXPERIENCE:
- Ph.D. in biomedical science, pharmacy, clinical pharmacology, biometrics or computational engineering
- 2 years of post-doctorate experience (academia and/or industry) with a proven track record within the duties mentioned above
- Published peer-reviewed articles
- Familiarity with the drug development process is an asset
- Experience working in a cross-functional matrix setting is also an asset
- Technical skills required:
- Demonstrated competence in coding and running pharmacometric related software (e.g. NONMEM, Monolix, R, MATLAB, PBPK software)
- Competence in at least one of the following areas: PK, PKPD, disease progression, malaria, in vitro in vivo correlation
- Fluency in English (oral and written)
- Familiar with general software
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 :
- A Ph.D. in Pharmacokinetics or related field with at least 10+ years industry experience.
- Ability to drive and lead ADME and PKPD strategies for discovery project teams.
- Ability to design and implement preclinical pharmacokinetic and PKPD studies required to support robust preclinical data packages.
- Experience as a team member on interdisciplinary project teams is essential, with experience on small molecule projects. Experience on biologics or other modalities is a plus.
- Strong written, presentation and verbal communication skills are essential
- Experience with IND/IMPD/CTA preparation and submission.
- Demonstrated ability to work in a matrix environment and experience working in a global environment is a plus.
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
- Provide support in clinical studies including protocol development, study monitoring, etc.
- Analyze PK and PK/PD data in support of dosage selection.
- Work in collaboration with internal and external partners.
- Contribute to regulatory activities in the group.
Job Requirements
- Ph.D. in Clinical Pharmacology, Pharmaceutical Sciences, or related field.
- 2+ years of industry experience.
- Clinical pharmacology expertise.
- Experience analyzing PK and PK/PD data using modeling software.
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:
- PhD in Drug Metabolism, Pharmacokinetics, Chemistry or related fields with 5-10 years of industrial experience in DMPK, Clinical Pharmacology or related fields.
- Have a proven record of in-depth knowledge of DMPK science and its application in drug development
- Profound knowledge of regulatory guidelines and experience in the preparation of regulatory documents Team player with strong communication skills in a multicultural environment
- Experience in Oncology and Immunology would be a plus Highly flexible and creative with a strong sense of responsibility
- Excellent knowledge of spoken and written English.
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
- Lead the implementation of model-based drug development strategies for assigned preclinical, clinical, and lifecycle management projects
- Execute relevant pharmacometric analyses: non-compartmental PK, PK/PD analyses, population PK and PK/PD, clinical trial simulations, meta-analyses, disease and systems biology modelling, and other modeling and simulation activities as appropriate for the project.
- Apply analytical methods in pharmacometrics to integrate knowledge of pharmacokinetics, pharmacodynamics, patient characteristics and disease progressions in support of optimal study designs
- Provide pharmacometrics contributions to regulatory documents including Investigator Brochures, Labeling and those required for regulatory meetings and regulatory filings. Provides resolution of pharmacometrics queries from regulatory agencies, taking a lead role in writing and reviewing responses to regulatory queries
- Write Modeling & Simulation Analysis Plans and Reports. - Analyze and interpret all study PK, PK/PD and pharmacometric outcomes. Ability to create PK/PD files according to standard specifications and to generate tables and listings as required
- Develop external alliances with partners, consultants, contract organizations and academic institutions to ensure timely conduct of all pharmacometrics deliverables for projects with high quality and development of junior colleagues in the discipline
- If hired at the AD level, Associate Directors will act as a mentor to junior pharmacometricians, providing strategic and technical guidance for their activities.
- A Ph.D. or equivalent degree with at least 3 years of experience OR a PharmD or equivalent degree with at least 5 years of experience OR an MS or equivalent degree with at least 8 years of experience, where experience means having a proven track record within the duties mentioned above in pharmaceutical industry, regulatory agency, or academia. Required Experience and Skills
- Educational background in pharmacometrics, clinical Pharmacology, biopharmaceutics, pharmaceutical sciences, mathematics, statistics/biostatistics, computational biology, biomedical engineering, or a related field.
- Proficiency in NONMEM, R or other similar programing language Preferred Experience and Skills
- In-depth knowledge and experience in performing population PK, PK/PD analyses using pharmacometrics software such as NONMEM, Phoenix, Monolix, R, SAS, etc.
- Advanced pharmacometrics knowledge in one of the following core sub-area: advanced Exposure-Response Models, Disease Models, Physiological-Based Pharmacokinetic Models, Quantitative Systems Pharmacology
- Experience leading and implementing all aspects of pharmacometrics needs across a variety of disease areas
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 skillsExternal 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.
- Represent clinical pharmacology on cross-functional project teams involved in the clinical development of candidate drug products.
- Collaborate with biostatisticians, clinicians and clinical operation managers for the optimal design of Phase I-IV studies; contribute to the clinical study protocols and reports.
- Work closely with sample management and bioanalytical.
- Assist in integrating and interpreting nonclinical and clinical pharmacology, DMPK, and translational medicine knowledge; in the preparation of clinical pharmacology write-ups and regulatory documents (IND, IMPD, IB, NDA CTD, etc).
- Create and manage of datasets and tasks such as non-compartmental and compartmental PK/PD analysis.
- Collaborate with pharmacometricians in the modeling of emerging PK and PK/PD data.
- Participate in writing publications and making scientific presentations consistent with development strategies.
- Maintain knowledge of relevant scientific and regulatory practices and trends, and ensure that clinical pharmacology aspects of development programs are contemporary. Other duties as assigned.
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:
- Perform advanced quantitative pharmacology and pharmacometric analyses and activities within assigned programs to yield high value PK/PD support for critical decisions and dose selection; interprets and presents results and recommends appropriate actions.
- Manage and develop clinical pharmacology efforts such as study designs, protocol preparation, data analysis and reporting.
- Supports the development and execution of the quantitative pharmacology strategy of clinical development teams.
- Provide insightful regulatory strategy for clinical pharmacology and modeling support of drug filings and is responsible for the respective sections of regulatory documents.
- Develop and maintain strong knowledge of best regulatory practices, clinical pharmacology principles, PK/PD analysis methodology and drug development precedent.
- Develop and maintain scientific awareness and presence in the clinical pharmacology and pharmacometric discipline, publishes manuscripts and posters, presents at scientific conferences and other scientific forums.
- Perform other related duties as assigned.
- PhD degree in Pharmacokinetics-Pharmacodynamics, Pharmacometrics, biomedical engineering, statistics, applied mathematics, or a related field
- Experience in developing advanced quantitative system in Pharmacometrics, PK/PD, PBPK models to aid in research and development decision making.
- Knowledge of Health Authority perspective on use of modeling and simulation.
- Excellent interpersonal, collaboration, English communication skills (both written and verbal).
- Strong analytical skills and strategic thinking.
- Proven ability to successfully manage projects and timelines, organize/track complex information, prioritize accordingly, and the ability to quickly adjust to shifting priorities and demanding timelines when necessary.
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:
- Ph.D. or Pharm D in Pharmaceutical Sciences, Pharmacometrics, or related field with 10+ years of experience in pharmaceutical industry. Demonstrated experience in serving as clinical pharmacology lead on development programs.
- Experience in non-compartment and model-based PK and PK/PD analyses and inclusion of data in the preparation of manuscripts, study reports and sections of regulatory submission documents (eg: INDs, NDAs, CTDs) is required.
- The incumbent should have a strong understanding of pharmacokinetic theory, compartmental modeling and simulation, and statistical approaches utilizing the latest computational approaches and tools
- Hands-on experience in utilizing WinNonLin, NONMEM and/or other modeling software is required. Experience with population PK, mechanistic PK-PD modeling/systems pharmacology and PBPK modeling is a plus. Familiarity with statistical approaches and programs for data analysis.
- Scientific writing and presentation skills are essential; peer reviewed publications in a relevant field required.
- Current knowledge of FDA regulatory guidance related to nonclinical and clinical pharmacology; experience having direct interaction with FDA, including submission of IND, NDA and other regulatory documents is required.
- Understanding of, and compliance with, regulatory, protocol, standard operating procedures, and Good Laboratory Practices (GLP) and Good Clinical Practices (GCP) as appropriate.
- Excellent interpersonal, leadership, communication and time-management skills are essential; demonstrated direct management of internal and external personnel (outsourced projects) is required.
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
- Serve as the pharmacometrics project representative on cross-functional teams.
- Develop and implement modeling and simulation plans and strategies.
- Support model-based drug development in support of dosage selection and go/no-go decisions.
- Manage timelines and budgets of the teams.
- Support regulatory activities and maintain overall regulatory compliance.
Experience Level
- Ph.D. in Pharmacokinetics, Pharmacometrics, or related discipline.
- 10-15+ years of industry experience.
- Experience working with clinical pharmacology, PK/PD, and/or pharmacometrics.
- Strong modeling and simulation expertise.
- Experience managing a multi-functioning group.
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:
- Provide PBPK and/or PKPD modeling expertise to preclinical and clinical projects for antimalarial treatment or chemoprevention
- Depending on the expertise of the applicant, the job could focus on one of the following areas or include both:/li>
- PK/PD analyses of non-clinical and clinical studies, especially of combinations of new antimalarial compounds
- Development and application of PBPK modelling: PK DDI assessment between antimalarial drugs used in a combination and between antimalarial drugs and other treatment; improve PK predictions in African children; predict the effect of malaria on PK, predict PK in pregnant and lactating women
- Publish high quality research articles
- Attend selected conferences for training, giving presentations and posters, representing MMV
EDUCATION AND EXPERIENCE:
- Ph.D. in biomedical science, pharmacy, clinical pharmacology, biometrics or computational engineering
- 2 years of post-doctorate experience (academia and/or industry) with a proven track record within the duties mentioned above
- Published peer-reviewed articles
- Familiarity with the drug development process is an asset
- Experience working in a cross-functional matrix setting is also an asset
- Technical skills required:
- Demonstrated competence in coding and running pharmacometric related software (e.g. NONMEM, Monolix, R, MATLAB, PBPK software)
- Competence in at least one of the following areas: PK, PKPD, disease progression, malaria, in vitro in vivo correlation
- Fluency in English (oral and written)
- Familiar with general software
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:
- PhD in Drug Metabolism, Pharmacokinetics, Chemistry or related fields with >10 years of experience in DMPK, Clinical Pharmacology or related fields
- Have a proven record of in-depth knowledge of DMPK science and its application in drug discovery
- Good scientific visibility through a substantial track record of relevant publications
- Team player with strong communication skills in a multicultural environment
- Strong negotiation skills with an ability to influence in complex situations
- Highly flexible and creative with a strong sense of responsibility
- Excellent knowledge of spoken and written English.
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
- Accountable for planning and executing state-of-the-art M&S techniques
- Scientific and strategic input into pre-clinical, clinical, and post-approval development plans
- Accountable for oversight, support and delivery of scientific and strategic modeling work related to specific projects
- Support evaluation of drug candidates for in/out-licensing
- Accountable for the identification and development of drug-disease models and other modelling approaches to support internal and external decision making in collaboration with internal and external partners (when relevant)
- Accountable to provide peer review and mentoring of junior staff
- Support and contribute to the development of the quantitative pharmacology in terms of providing training and knowledge sharing
- Monitoring external and internal environment in terms of relevant new methodologies and applications
- Ensure modeling efforts are aligned with current regulatory expectation
- Partner with the Preclinical Pharmacokinetic/Pharmacodynamics Team to enable translational PKPD efforts in the Discovery space
- PhD with 10-15+ years experience in industry
- Significant experience in modelling and simulation including PK, PKPD and statistics
- Demonstrated broad translational and clinical development expertise and experience exemplified by 15 years drug development experience (early and late), with emphasis on Pharmacometrics
- International recognition in the field on pharmacometrics
- Relevant regulatory experience (written/oral)
- Experience in managing and mentoring junior scientists, modelers and pharmacometricians
- Expert knowledge about modeling softwares, MATLAB, NONMEM, WinNonlin etc.
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