Director, Clinical Pharmacology and Pharmacometrics, REMOTE, United States send resume/CV and questions to firstname.lastname@example.org
Director, clinical pharmacology and pharmacometrics will be responsible to lead projects from early through late-stage clinical development including phase 3 and beyond with an emphasis on clinical dose selection/refinement as well as predictive PK/PD modeling. This will include population and statistically-based methodologies, as well as mechanistic and translational-focused approaches. This role has a highly strategic component but will also include some hands on work in combination with junior scientists and select vendor partners. This is a highly visible and team-facing role.
- Will be a lead authority on clinical pharmacology and pharmacometrics strategy across all stages of drug development
- Will serve as departmental and company expert in clinical and translational strategies, protocol preparation, study execution, data review and analysis, and study reports
- Responsible for model-based data analysis including population PK, PK/PD modeling and simulation, disease modeling, and meta analysis to inform clinical development
- Will be the functional lead for global regulatory strategies and health authority engagement
- Expected to maintain up to date knowledge in clinical pharmacology and pharmacometrics disciplines including new strategies/technology/software, manuscript publication, presentations at scientific conferences and meetings
- serve as a mentor to junior scientists
- PhD in Pharmaceutical Sciences, mathematics/engineering or related field
- 7+years of experience working in clinical pharmacology and pharmacometrics
- Strong understanding of clinical pharmacology principals
- Strong hands on experience with PK/PD modeling and regulatory guidelines
- hands on experience with tools such as WinNonLin, NONMEM, R, and other relevant software
- Excellent written and verbal communication skills
- Ability to prioritize and multitask
Contact email address: email@example.com - 19th Sep 2023 
Senior Director Clinical Pharmacology role available! My client is a mid sized pharma dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, endocrine and psychiatric disorders. The company’s diverse portfolio includes FDA-approved treatments for tardive dyskinesia, Parkinson’s disease, endometriosis* and uterine fibroids*, as well as clinical programs in multiple therapeutic areas. There is a partnership with large pharma. Incredible financial stability and overall benefits package. This role is onsite in San Diego, CA. Please reach out to me with any interest, questions or leads/referrals. Relocation assistance is available. Job Description Develops overall Clinical Pharmacology scientific strategies for assigned Therapeutic Areas (TA) and contributes to the broader functional strategy. Oversees all aspects of pharmacokinetic and pharmacodynamic activities for clinical development compounds. Key member of clinical protocol development at all stages and ensures appropriate assessment of Clinical Pharmacology endpoints. Represents Preclinical Development as expert to multidisciplinary project teams for assigned TA/Program, advises Sr. Technical Leadership and Executive Management and regularly interfaces with internal and external colleagues to ensure timely and accurate dissemination of Clinical Pharmacology findings.
- Develops Clinical Pharmacology and quantitative program strategies for assigned TAs that enable development and regulatory decisions
- Provides small and/or large molecule clinical pharmacology expertise to cross-functional project teams and support for the preparation of regulatory submissions
- Develops new innovative and impactful clinical pharmacology approaches to processes and drug development strategies
- Leverages quantitative modelling and simulation tools to answer development questions and to design and inform clinical trial designs and clinical development strategy
- Represents clients at meetings and advisory hearings with global health authorities as a subject matter expert
- Collaborates in teams both internally and externally as a strategic advisor on regulatory, clinical development, clinical pharmacology, and other development issues
- Contributes to training and mentoring for staff, develops junior staff for broader functional roles
- Writes and compiles reports and other documents summarizing recommendations
- Involvement in program committees, workshops, and other professional organization meetings/sessions
- Other duties as assigned
- PhD in pharmacology or pharmacokinetics, or in a related scientific discipline or PharmD and PhD in pharmacology or pharmacokinetics, or in a related scientific discipline or PharmD and 10+ years of drug development experience including clinical pharmacology and regulatory science expertise in the pharmaceutical industry OR
- Master's in Pharmacokinetics, Pharmaceutical Sciences or closely related discipline and Master's in Pharmacokinetics, Pharmaceutical Sciences or closely related discipline and 13+ years of relevant experience OR
- Bachelor's in chemistry, life sciences or closely related discipline and 15+ years of relevant experience
- Capable of assembling a multidisciplinary team to execute the components of clinical pharmacology program
- Exemplary scientist, innovator, drug hunter/developer, expertise in several areas, expert in current area. Exhibits learning agility
- Extensive knowledge of managing clinical Contract Research Organizations
- Proven track record in preparation of INDs, CTAs, NDAs, and MAAs as well as successful results from the filings
- Expert knowledge of in silico modeling and simulation tools
- Demonstrated knowledge on current regulatory guidance’s
- Ability to develop scientific insights from highly complex data sets; extensive knowledge of pharmacokinetic and pharmacodynamic data interpretation for clinical development compounds
- Recognized as an internal thought leader with extensive technical and business expertise within a strategic organization
- Recognized Internal thought leader and deep expertise in a discipline
- Requires broad, deep and comprehensive expertise in leading-edge theories and techniques for functional area
- Applies ingenuity and creativity to problem analysis and resolution in complicated and/or novel situations
- Strong mentoring skills and leadership abilities supervise lower levels and/or leads indirect teams
- Proven ability to translate strategy into tactical plans and drive outcomes
Contact email address: firstname.lastname@example.org - 11th Sep 2023 
Associate Director / Director, Clinical Pharmacology Direct Hire Waltham, MA
- Provide clinical pharmacology and PK expertise and oversight during clinical study design and execution.
- Perform noncompartmental PK and PD analyses of clinical trial data and collaborate with Data Management to ensure compliance with CDISC standards.
- Contribute to clinical trial related documents (protocols and amendments, informed consent forms, site training materials, statistical analysis plans, clinical study reports)
- Collaborate with senior staff to develop strategies and direct efforts in clinical pharmacology to meet regulatory requirements.
- Implement clinical pharmacology tools and technologies to drive efficient drug development.
- Partner with Quantitative Scientists to apply state-of-the art population PK, PK/PD, PBPK, and QSP modeling concepts to inform clinical trials and for regulatory submissions.
- Organize and interpret data, and present analyses to key internal (development teams, senior management) and external stakeholders (advisory boards, scientific meeting abstracts, posters, and manuscripts).
- Develop and maintain collaborative working relationships with colleagues within and outside the department.
- PhD, PharmD or MD degree with emphasis in clinical pharmacology, pharmacokinetics or a related scientific discipline.
- A minimum of 7 years relevant experience in the biotech/pharmaceutical industry; minimum of 3 years in large molecule clinical pharmacology experience.
- Demonstrated ability to critically analyze problems and provide innovative solutions.
- Experience in the design, coordination, and implementation of clinical studies.
- Knowledge of contemporary PK, population PK, QSP modeling concepts, data analysis, and interpretation; hands-on experience with applying these concepts to support clinical development and regulatory submission; desire and curiosity to acquire scientific knowledge for portfolio projects.
- Hands-on experience with noncompartmental PK analysis of clinical trial data and familiarity with CDISC standards.
- Proficiency and experience in using common PK / PD modeling software packages (i.e., Phoenix WinNonlin, NONMEM, R, SAS, and other similar tools)
- Excellent project management skills and familiarity with GxPs.
- Flexible, results-oriented, and demonstrated ability to work in a fast-paced, timeline-driven environment.
- Excellent written and verbal communication skills and ability to convey complex technical information clearly.
Contact email address: email@example.com - 3rd Aug 2023 
Research Associate/Postdoctoral Researcher for Interdisciplinary and Translational Research that Integrates Pharmacology, Biology, and Computational Modeling to Facilitate Development of More Efficacious Drug Therapies for Brain Cancer
Karmanos Cancer Institute, Wayne State University School of Medicine, Detroit, MI, USA
Applications are invited for a Research Associate/Postdoctoral Researcher position available at Karmanos Cancer Institute, Wayne State University (Detroit, MI, USA). This is a non-tenure track position, supported by a National Cancer Institute (NCI) funded R01 grant for three years. The goal is to help the postdoctoral researcher to grow and transit into an indepen¬dent principal investigator.
Applications are strongly encouraged for candidates with strong mathematical and computational background who are interested in career development opportunities in the interdisciplinary and translational research that integrates biology, pharmacology, mathematics, and computational modeling to facilitate development of more effective drug therapies for brain cancer.
The postdoctoral researcher will be mentored jointly by Dr. Jing Li (Professor of Oncology and Director of Pharmacology and Metabolomics Core at Karmanos Cancer Institute), Dr. Seongho Kim (Professor and Director of Biostatistics and Bioinformatic Core), and Dr. Hengguang Li (Professor of Mathematics and Chair of Department of Mathematics at Wayne State University).
The postdoctoral researcher will work on a NCI-funded R01 project with the overall goal to develop novel mechanistic, physiologically based pharmacokinetics/pharmacodynamics (PBPK/PD) models for prediction of drug disposition and action in the central nervous system (CNS) in brain cancer patients. Insufficient penetration of potentially effective chemotherapeutic agents across the human blood-brain barrier (BBB) is a huge hurdle to successful treatment of brain cancer. Mechanistic understanding and early prediction of drug penetration into the human CNS is of paramount importance to rational drug development and treatment for brain cancer. Given the fact that drug disposition and action in the human CNS is determined by not only drug properties but also biological system characteristics, preclinical-to-clinical translation of CNS PK/PD is complicated by biological system differences. Hence, the development of innovative approaches is imperative. The in vitro-in vivo extrapolation-PBPK/PD model offers a unique platform that allows simultaneous incorporation of drug- and system-specific parameters into a PK/PD model and enables a priori prediction of in vivo PK/PD processes based on mechanistic scaling of in vitro data (e.g., in vitro enzyme and transporter kinetics, and receptor binding parameters). Our research has been focused on the development of innovative computational models for mechanistic prediction of disposition and action (i.e., PK/PD) of anticancer drugs in the CNS in brain cancer patients. The obtained quantitative information is of enormous value to rational development and optimal use of drug therapies for more efficacious treatment of brain cancer.
A PhD in computational mathematics, computer science, or a related discipline is required. Expertise in R or Matlab is preferred. Knowledge of biology, medicine, or pharmacology is an advantage, though not a requirement. All qualified applicants will receive consideration for employment without regard to race. Interested candidates should apply by sending the application letter and curriculum vita to Dr. Jing Li (firstname.lastname@example.org). Applications will be considered until the position is filled. The intended start date is September 1. 2023. An earlier or later start date may be considered. Questions should be directed to Dr. Jing Li.
Contact email address: email@example.com - 15th Jul 2023 
The Graduate Research Training Program PharMetrX: Pharmacometrics & Computational Disease Modelling is an interdisciplinary PhD program bridging pharmacy and mathematics. PharMetrX 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 applying pharmacometric // PK, PD, disease 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 working groups and supervision, an individual mentorship from one of the associated industry partner consortium, a specifically tailored training program of compact academic and industry modules, a network of >100 peers and a competitive 3.5 years fellowship.
The PharMetrX Training+ Program (Training & Network) offers a specifically tailored training program of compact academic and industry modules that convey the foundations in pharmacokinetics & pharmacodynamics, systems biology, statistics, methodological approaches of modelling & simulation etc. as well as a network of >100 peers. It is open for PhD students who have already started their PhD in the field of pharmacometrics since March 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.
Deadline for applications: 15 September 2023.
PharMetrX is a joint program of Freie Universität Berlin and the University of 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: firstname.lastname@example.org - 10th May 2023 
JOB PURPOSEMMV is a Swiss non-profit foundation whose mission is to reduce the burden of malaria in disease-endemic countries by discovering, developing and delivering new, effective and affordable antimalarial drugs.
Working with drug discovery/development partners in academia and industry,
as well as with country-based delivery partners and national ministries
of health/malaria control programmes, MMV’s focus extends from the
identification of new potential treatments for malaria through to clinical
development, regulatory approval and delivery-for-impact in
malaria-endemic countries. Since its founding in 1999, MMV and partners
have brought forward 11 new medicines that have saved an estimated 2.7
We are currently seeking a PKPD postdoc to join our Pharmacometrics team. We are seeking a highly motivated individual who will provide scientific expertise in PKPD modelling as well as modelling and simulation strategy.
PRIMARY DUTIES AND RESPONSIBILITIES:
- Develop innovative models to help the integration of new data and/or new experiments
- Provide PBPK and/or PKPD modeling expertise to preclinical and clinical projects to help speed-up the development of molecules for antimalarial treatment or chemoprevention
- Develop and apply modelling solutions for monotherapy and combination therapy
- 20% of time will be allocated to a specific research project, supporting MMV’s strategy, to develop an innovative PKPD modeling approach
- Author and publish high-quality research articles
- Attend selected conferences for training, giving presentations and posters, representing MMV, and building a network
EDUCATION AND EXPERIENCE:
START DATE: As soon as possible
DEADLINE: May 31, 2023
Contact email address: email@example.com - 9th May 2023 
PhD student in microbiology and PKPD mathematical modelling
Organization/company: Location: INSERM U1070, Poitiers Country: France Website: https://phar.labo.univ-poitiers.fr/ Mandatory degree: Master 2 Application deadline: 11th June 2023 Starting date: 01/09/2023 Type of contract: Full-time 3 years Funding: ANR/JPIAMR programs Net salary: approximately 1650 €/month
Offer Description :
The candidate will work on two international collaborative projects DeCa-P (1) and STARS-TAP (2). These international projects will involve extensive collaboration with the microbiology team of Christian Lesterlin and Sarah Bigot in Lyon, France (3).
In DeCa-P, we aim to better understand emergence of multi-drug resistant bacteria through study of plasmidic transfer. More precisely we aim to find genetic and environmental factors influencing the plasmidic transfer abilities and rate. To do so, we will focus on the pOXA-48a conjugative plasmid that encodes an OXA-family carbapenemase responsible for carbapenem resistance among Enterobacteriaceae.
In STARS-TAP, plasmids rather than being foes are turned into friends. Indeed, Targeted-Antibacterial-Plasmids (4) (TAPs) are plasmids that use DNA conjugation to deliver CRISPR/Cas systems to specifically target and kill specific bacterial strains based on their genome. If successful, the use of TAPs would enable preventive removal of strains harboring drug-resistance strains from microbiomes.
In this project the candidate will have two main tasks: 1) perform in vitro microbiology experiments (MIC, time-kill curves) where the effect of antibiotics on plasmidic transfer ability and rate (DeCa-P) and evaluate the combined efficacy of TAPs with antibiotics (STARS-TAP); 2) develop mathematical models to quantify plasmidic transfer rates, genetic and environmental impact on these rates, TAPs + antibiotic efficacy. The models will be based on in vitro data generated in both projects by the candidate and the project partners.
The successful candidate will be part of our research unit affiliated to the University of Poitiers and INSERM. We are a transversal group created in 2012 with the aim to optimize antibiotic usage through collaboration between microbiologists, pharmacologists, pharmacometricians, drug formulation researchers, cellular biologists, chemical analysts and clinicians.
We are developing innovative pharmacokinetic-pharmacodynamic (PKPD) modelling approaches to select the best dosing regimen of antibiotics administered alone or in combination as well as the best route of administration and best formulation. We conduct translational research, from cell culture to patients, by integrating microbiology, analytical chemistry, drug formulation, and in vivo preclinical experiments.
- A masters 2 (MSc. With 240 credits) in pharmacometrics / pharmaockinetics / pharmacodynamics / bioinformatics / microbiology or a related field is mandatory.
- Basic knowledge and practice of pharmacometric PKPD modelling and/or mathematical modelling of genetic and plasmidic transfer dynamics is mandatory.
- Basic knowledge and practice of basic microbiology experiments (Work in a BSL2 environment, MIC measurement of an antibiotic by microdilution, time-kill experiments) and flow cytometry is mandatory.
- Proficiency in written and oral English is a merit, B2 European level is a minimum.
- Familiarity with scientific programming languages (e.g. R, Python) is a merit
Send an email with a cover letter and a CV and one or two professional reference contact to firstname.lastname@example.org, email@example.com and a cc to firstname.lastname@example.org
External website https://phar.labo.univ-poitiers.fr
Contact email address: email@example.com - 8th May 2023 
Associate Director Bioanalysis (gn) function at Top Global Player in Germany
We are currently assigned to recruit an Associate Director Bioanalysis (gn) for a top Global Player in Biopharma in the South of Germany. (being on-site is a must)
Please find here the details:
For a globally leading biopharmaceutical company, we are currently looking for an Associate Director Bioanalysis (gn). As such, you are responsible and accountable for a team of highly motivated and skilled professionals and technically lead the bioanalytics team with focus on mass spectrometry.
- You lead, motivate, and develop a team of ~20 co-workers in different lab sub-teams
- You are responsible for bioanalytics and metID, including quantification of samples from DMPK and different therapeutic areas
- You and team deliver high-quality results with essential impact on the overall discovery pipeline and shape innovative profiling strategies internally and externally with CROs
- You are involved in early DMPK projects and work closely together with interdisciplinary project teams
- You ensure a continuous development and evolution of bioanalytical technologies and sciences
- You maintain and develop close relationships with several network within the pharmaceutical industry and academia
- You are the spokesperson for your division and represent both the team and organisation internally and externally
- PhD in natural sciences
- Extensive experience with bioanalytics with a clear focus on mass spectrometry
- Proven leadership skills
- Highly dedicated scientific expert and team player
- Fluency in English, good command of German (and/or willingness to learn)
Dilsad Babayigit CEO ageneo Life Science Experts GmbH
3rd May 2023 
Parexel is one of the only CROs to provide a broad depth of Clinical Pharmacology, Modeling and Simulation (CPMS) expertise to our clients, and the group is growing its capabilities and expanding globally!
We currently have tremendous opportunities available for pharmacometrician and clinical pharmacologist to join this extremely collaborative and super friendly team! If you’re looking for an opportunity to be empowered, expand professionally, do more than a narrow scope of work, work alongside a large team of CPMS experts, and provide solutions to a variety of clients with various products in different stages of development across multiple therapeutic areas, apply today at:
External website https://www.parexel.com/
Contact email address: firstname.lastname@example.org - 17th Apr 2023 
Director/Head of US pharmacometrics role available!
I am currently recruiting for a large pharma client looking to establish a pharmacometrics group in the US. The successful candidate for this role will have a strong background in quantitative pharmacology, MIDD, and pharmacometrics. Ideally having management experience is also a plus as there will be the responsibility to grow the group and manage individuals career development. This is a unique opportunity to build and grow a group in a highly visible setting with global exposure, but with the stability of a company with a large portfolio of marketed products and robust pipeline. A PhD with NONMEM experience is required along with 7+ years in industry or related field. Will have some hands on modeling responsibilities as well as strategic and managerial component to the role. Please contact me at email@example.com for more info and we can set up a call to discuss.
cell is 315-415-4353
External website https://firstname.lastname@example.org
Contact email address: email@example.com - 23rd Mar 2023 
Postdoctoral position in Drug Metabolism and Pharmacokinetics group is available at The
Johns Hopkins University with Johns Hopkins Drug Discovery (JHDD) https://drugdiscovery.jhu.edu.
The candidate will work with a multidisciplinary drugdiscovery team focused on the discovery and development of novel small molecule
drugs in the areas of Neurology, Oncology, Gastroenterology, Ophthalmology, and
Immunology. The individual selected will be responsible for the analytical method
development (MS/MS), pharmacokinetic analyses, drug permeability analyses, drug
metabolism (liver microsomes, S9, hepatocytes, etc.), and protein binding studies. In
addition, he/she will be expected to also understand the absorption, distribution and
elimination principles for application to the characterization of internal drug
JHDD will provide a dynamic research environment including interactions with JHU
faculty, medicinal chemists, biochemists, cell biologists and in vivo pharmacologists,
as well as interaction with several Pharma industrial partners.
Requirements for the position include:
- A Ph.D. degree in pharmaceutical sciences or a related field
- Knowledge of in vitro techniques, cell culture, LC/MS, drug delivery and pharmacokinetics is desirable
- Ability to perform effectively in a team environment
External website https://drugdiscovery.jhu.edu
Contact email address: firstname.lastname@example.org - 22nd Mar 2023 
The University of Minnesota’s College of Pharmacy, Department of Experimental and Clinical Pharmacology (ECP) is seeking a faculty member who will complement our existing strengths in pharmacometrics by contributing field-shaping science to the areas of quantitative systems pharmacology, systems biology, disease modeling, methodological or computational skills related to pharmacometrics. This position aligns with the College of Pharmacy’s strategic plan to build expertise within the theme of precision medicine. Individuals will be expected to apply their pharmacometrics expertise to advance discovery and translation in precision medicine through development of innovative methodological tools and application of physiologic, pharmacokinetic and/or pharmacodynamic modeling.
Summary of Position:
The University of Minnesota’s College of Pharmacy, Department of Experimental and Clinical Pharmacology (ECP) invites applications for the position of Assistant or Associate Professor with a focus in Pharmacometrics. This is a 12-month, 1.0 FTE position. Successful candidates will possess an earned doctorate (e.g., Pharm.D., M.D., Ph.D.), and must have research experience that will enable them to establish a strong program of scholarly contributions to the field of pharmacometrics applied to clinical/translational research and precision medicine. The successful applicant will conduct research and teach professional pharmacy students and graduate students in the area of pharmacometrics. They will also provide service to department, collegiate and university initiatives and committees. The candidate will interact with members of other disciplines, schools, centers and research groups at the University to advance our capacity of making significant contributions to quantitative systems pharmacology.
About the Department:
The Department of Experimental and Clinical Pharmacology (ECP) is at the forefront of the emerging discipline of experimental pharmacotherapeutics, providing national and international leadership in individualized medicine through prominent research and an excellent graduate program. Groundbreaking and critical research is conducted in the Department of Experimental and Clinical Pharmacology. Our faculty are renowned experts in pharmacogenomics, neuropharmacology, drug metabolism, pharmacometrics, and specific therapeutic areas. Within the department, there is a diverse portfolio of supported research projects with funding from government, corporate, and foundation sources. Faculty members regularly present important findings at national and international conferences, lecture and collaborate across the country, and hold leadership positions in national organizations. Our graduate program offers M.S. and PhD degrees in an innovative, interdisciplinary program that trains students of the highest caliber to conduct research encompassing methodology from basic and clinical pharmacology perspectives. Additionally, ECP faculty contribute significantly to the education of pharmacy students in the College’s professional program through didactic instruction, laboratory experiences, clerkships and clinical rotations.
To view qualifications and apply, please visit: https://z.umn.edu/MetricsECPExt
External website https://z.umn.edu/MetricsECPExt