Research Associate/Postdoctoral Researcher for Studying the Pharmacokinetics (PK) and Pharmacodynamics (PD) of Anticancer Drugs in the Central Nervous System (CNS)
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, a NCI-designated comprehensive cancer center (located in Detroit, MI, USA). This is a non-tenure track position, supported by a National Cancer Institute (NCI) funded R01 grant for two or three years. The goal is to help the postdoctoral researcher to grow and transit into an independent investigator in an academic institution or pharmaceutical company.
The postdoctoral researcher will work on the NCI R01 project that aims to mechanistically understand and quantitatively predict drug disposition and action in the central nervous system (CNS) in 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 distribution and disposition in the human brain and brain tumors is critical to rational drug development and treatment for brain cancer. This project employs an integrated research approach that leverages preclinical in vitro and in vivo pharmacology studies, physiologically based pharmacokinetic (PBPK) modeling, and clinical trials to better understand and predict CNS PK in cancer patients.
Applications are strongly encouraged for candidates with cancer biology and pharmacology background who are interested in career development opportunities in clinical pharmacology and drug development either at an academic institution or pharmaceutical company. A PhD in cancer biology, pharmacology, pharmaceutical sciences, or a related discipline is required. Expertise in tumor models and animal PK/PD studies is preferred. Knowledge of PK/PD modeling is an advantage, though not a requirement. All qualified applicants will receive consideration for employment without regard to race.
The postdoctoral researcher will be mentored by Dr. Jing Li, Professor of Oncology and Pharmacology and Director of Pharmacology and Metabolomics Core at Karmanos Cancer Institute. The postdoc will work with a multidisciplinary team with complementary expertise in pharmacology, analytical chemistry, molecular biology, and computational PK/PD modeling.
Interested candidates should apply by sending the application letter and curriculum vita to Dr. Jing Li (lijing@wayne.edu). Applications will be considered until the position is filled. The intended start date is May 1. 2024. An earlier or later start date may be considered. J-1 or H-1b visa will be sponsored if needed.
Contact email address: broseberry@cartermackay.com - 28th Feb 2024 [3160]
New Director role in Pharmacometrics available. Large company. Remote is okay within the US or can be onsite in the tristate area (NY/NJ/CT). If interested, please let me know. Small and large molecule therapeutics. Therapeutic area somewhat diverse, many project in oncology, CNS, among others. Please email me at broseberry@cartermackay.com for more info and to discuss.
Responsibilities
- Responsible for pharmacometrics strategy on the program level to evaluate risk/benefit and facilitate drug development decisions. Will work in close collaboration with translational science colleagues and other R&D partners and serve as department project lead and representative.
- Lead design and implementation of the PMX strategy and other advanced MIDD approaches to enable quantitative decision making thorough the drug development cycles
- Manage and perform pharmacometric analyses (both internally and by external CRO vendors) using various tools and approaches
- Integrate, interpret, and report results to project teams and upper management!
- Proactively contribute into key pre-clinical, clinical, and regulatory documents ; clinical study protocols, clinical study reports, modeling reports, investigator brochures, IND and BLA/NDA's within agreed timelines, and meeting all regulatory requirements
- Maintain and enhance technical and drug development expertise (e.g. training courses, external meeting attendance)
- PhD in clinical Pharmacology/Pharmaceutical sciences/pharmacology/Statistics/engineering with academic training in Pharmacometrics. Ideally 10 years industry or related experience. Use of NONMEM and R is required.
- Strong quantitative skills and expertise (e.g. experience in areas such as literature meta-analyses, population modeling, E-R, and clinical trial simulations) mechanistic modeling experience is a plus
- Excellent knowledge of drug development process
- Communication and presentation skills
8th Feb 2024 [3159]
We're currently looking for a motivated candidate to fill an Internship position at PMX group at Novartis. If you're a PhD student in the field of pharmacometrics/ clinical pharmacology/ modelling interested in getting pharmaceutical industry experience don't miss out on this great opportunity and apply today.
Your responsibilities:
- This internship will focus on longitudinal population pharmacokinetic and pharmacodynamic (PD) modelling of biologic agents targeting the support for dermatology portfolio at Novartis. Various clinical problems will give the candidate a hands-on exposure to questions to be addressed in drug development.
- Work on your own Pharmacometrics modeling project under the guidance of senior-level quantitative scientists
- Present your project results to quantitative scientists and other stakeholders
- This internship will provide motivated students with exposure to the pharmaceutical industry, and with the opportunity to work in an exciting, multi-disciplinary and multi-cultural environment with senior-level scientists
- At the end of internship, the candidate will have gained in-depth experience in a wide range of aspects related to modelling of monoclonal antibodies including:
- Population pharmacokinetic analysis
- PK-binding models
- Exposure-response modelling for clinical end points
- Model-based simulations
- Current students enrolled in a PhD degree
- Candidates should be in an accredited degree-granting college or university pursuing a graduate degree in Pharmacometrics or Mathematics/Statistics, Physics, Bioinformatics, Biomedical Sciences or Pharmaceutical Sciences/Pharmacy
- Ideal candidate should have a good familiarity with quantitative methods and longitudinal modeling in one-two domains among the following: mathematical, statistical, biological, pharmacological
- Candidates must have excellent oral and written communication skills in English as well as strong problem-solving skills
- Working knowledge of data exploration with R is required, familiarity with nonlinear mixed effects modelling and basic pharmacologic concepts of monoclonal antibodies, as well as resp. software (Monolix or NONMEM) is of advantage.
Best regards, Andrzej
External website https://www.novartis.com/careers/career-search/job-details/391082br/internship-pharmacometrics
Contact email address: telder@stem-sourcing.com - 31st Jan 2024 [3158]
Associate Director / Director Bioanalytical search is now active! Please message me to learn more. We are seeking a dynamic and experienced Bioanalytical Director to join our growing company. The ideal candidate will bring expertise in both small and large molecules, biomarkers, immunogenicity, ADA, and hands-on experience in biologics. This individual will play a crucial role in providing technical leadership, troubleshooting ligand binding assays, and supporting clinical trials in a cross-functional environment. If you are a highly skilled professional with a proven track record, excellent communication skills, and a passion for making a significant impact, we invite you to apply.
Responsibilities:
Technical Expertise:
- Demonstrate strong technical proficiency in ligand binding assays, with the ability to troubleshoot assays based on data analysis.
- Hands-on experience with small and large molecules, biomarkers, immunogenicity, and ADA.
- Collaborate with cross-functional teams to support bioanalytical aspects of clinical trials.
- Provide expertise in designing and implementing bioanalytical strategies to meet regulatory requirements.
- Work closely with colleagues in research, development, and regulatory affairs to ensure seamless integration of bioanalytical activities.
- Foster a collaborative environment and contribute to the development of innovative solutions.
- Experience in cell-based assays is a plus, contributing to the overall diversity of bioanalytical capabilities.
- Possess excellent written and verbal communication skills to effectively convey complex scientific concepts.
- Collaborate with internal and external stakeholders to provide updates on bioanalytical progress.
- Be willing and able to fill gaps in the workflow to achieve departmental and company goals.
- Contribute proactively to process improvements and operational efficiency.
- Advanced degree (Ph.D. or equivalent) in a relevant scientific discipline.
- Substantial experience (at least 8-10 years) in bioanalytical roles within the pharmaceutical or biotechnology industry.
- Proven expertise in ligand binding assays and bioanalytical method development.
- Hands-on experience with small and large molecules, biomarkers, immunogenicity, and ADA.
- Clinical trial support experience, including collaboration with cross-functional teams.
Strong communication skills and the ability to convey technical information to diverse audiences.
External website https://www.stem-sourcing.com
Contact email address: jchapman@haallc.com - 26th Jan 2024 [3157]
Job Description
One of our top clients is looking for an Associate Director of Clinical Pharmacology.
Responsibilities
- Guide the model-based activities including disease-progression models and meta-analyses.
- Perform analysis of PK/PD, exposure-response, and translational modeling data to support dosage selection.
- Partners with colleagues for the interpretation of preclinical pharmacology studies.
- Provide input in regulatory documents.
Job Requirements
- Ph.D. in Clinical Pharmacology, Pharmaceutical Sciences, or related field.
- 5+ years of industry experience.
- Experience in translational research and/or pharmacometrics.
- Proficient in using pharmacometrics tools such as NONMEM, Monolix, WINNONLIN, and R.
Interested? Send a copy of your CV and/or any questions you may have to Jay Chapman, jchapman@haallc.com.
Contact email address: jchapman@haallc.com - 26th Jan 2024 [3156]
Job Description
One of our top clients is looking for a Director of Clinical Pharmacology.
Responsibilities
- Design a clinical development program.
- Guide the model-based activities including disease-progression models and meta-analyses.
- Perform analysis of pop PK, PK/PD, and exposure-response data to support dosage selection.
- Interpret clinical pharmacology studies.
- Write sections of drug development and registration documents.
Job Requirements
- Ph.D. in Clinical Pharmacology, Pharmaceutical Sciences, or related field.
- 8+ years of industry experience.
- Clinical pharmacology expertise in the oncology therapeutic area.
- Experience using pharmacometrics tools such as NONMEM, Monolix, WINNONLIN, and R.
Interested? Send a copy of your CV and/or any questions you may have to Jay Chapman, jchapman@haallc.com
Contact email address: telder@stem-sourcing.com - 16th Jan 2024 [3155]
Currently seeking a Remote Hybrid A/D Director at a senior level in Clinical Pharmacology Pharmacometrics! Our new oncology company is looking for a scientist to lead the charge in clin pharm and PMx. The role will be hands-on, working with a pipeline of several assets from discovery through phase 1/2. The CEO and CMO both were previously at Merck and are looking to add even more talent to their already impressive team. We require a PhD in Pharmaceutical Sciences, mathematics/engineering or related field, with over 5 years of experience working in clinical pharmacology and pharmacometrics. Strong understanding of clinical pharmacology principals is a must, as is hands-on experience with PK/PD modeling and regulatory guidelines. Experience with tools such as WinNonLin, NONMEM, R, and other relevant software is essential. If you're interested in joining our team, please apply today! #ClinicalPharmacology #Pharmacometrics #OncologyResearch #PhD #RemoteWork
External website https://www.stem-sourcing.com
Contact email address: broseberry@cartermackay.com - 14th Nov 2023 [3152]
Director, Pharmacometrics--Remote, US, large pharma please email broseberry@cartermackay.com for more info
Responsibilities Responsible for the design and implementation of PMX strategy at the program level; the construction, validation, and implementation of disease, placebo, exposure-response, and mechanistic PKPD models to evaluate risk/benefit and facilitate drug development decisions, in close collaboration with colleagues
- Lead design and implementation of the PMX strategy and other advanced MIDD approaches to enable quantitative decision making thorough the drug development cycles
- Perform pharmacometric analyses, including oversight of external vendors
- Integrate, interpret, and report results to project teams
- Proactively contribute into key pre-clinical, clinical, and regulatory documents such as clinical study protocols, clinical study reports, modeling reports, investigator brochures, IND and BLA/NDA's, adhering to regulatory guidelines
- Collaboration within drug development teams (e.g. DMPK, Regulatory Affairs, Clinical Development, and Biostatistics)
- Maintain and enhance technical and drug development expertise (e.g. training courses, external meeting attendance)
- Act as technical subject matter expert in key clinical pharmacology / DMPK / pharmacometric related area
- PhD in clinical Pharmacology/Pharmaceutical sciences/pharmacology/Statistics/engineering with training in Pharmacometrics
- Minimum 10 years of hands on industry experience in Pharmacometrics, considerations will be made for a combination of academic and industry experience, and level can be flexible between AD and Director for solid candidates with less experience
- Strong quantitative skills and expertise (e.g. experience in mechanistic PKPD modeling/systems pharmacology, literature meta-analyses, population modeling, and clinical trial simulations)
- Excellent knowledge of drug development process
- Communication and presentation skills
Contact email address: catia.marzolini@usb.ch - 31st Oct 2023 [3151]
PhD thesis in physiologically based pharmacokinetic modeling combined with therapeutic drug monitoring: Lausanne, Switzerland
A fully funded PhD position is available in the Service of Clinical Pharmacology at the University Hospital of Lausanne. Therapeutic drug monitoring (TDM) is a strong and longstanding area of development in our center which provides drug measurements and clinical interpretation for a large variety of medications. The candidate will contribute to the routine activity of TDM. In the framework of the research activity, the candidate will develop physiologically based pharmacokinetic (PBPK) models combined with TDM data to address clinical gaps related to drug prescribing (e.g., dosage adjustment to overcome drug-drug interactions, dosage adjustment in special populations). 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.
You are a highly motivated pharmacist. Experience in modelling will be an advantage.
This position is also open to candidates from the European Union. The working language is French (TDM activity). A good knowledge of English is warranted for the research work.
Application/contact
Please send one PDF file including CV with academic transcripts, publications/ presentations at conferences, two academic references as well as a letter of motivation to:
Prof. C. Marzolini: catia.marzolini@usb.ch
Applications will be considered until November 20, 2023. The position is available from January 2024.
Please note that there will be no follow-up correspondence for applications that do not fulfill the position requirements.
30th Oct 2023 [3150]
POSTDOCTORAL ASSOCIATE, DUKE CLINICAL RESEARCH INSTITUTE
Occupational Summary
Provides support in the design and preparation of clinical pharmacokinetics development strategies and study protocols, performing pharmacokinetic (PK) and pharmacodynamic (PD) analyses, and preparation of clinical study reports and integrated summary documents. Conducts and coordinates the PK/PD analysis or statistical efforts for clinical trials at all stages of drug development.
** NOTE: This is a remote position with the opportunity for individuals local to Durham, NC, to work on-site. All Duke University and Duke Health remote workers must reside in one of the following states or districts: Arizona; California; Florida; Georgia; Hawaii; Illinois; Maryland; Massachusetts; Montana; New Jersey; New York; North Carolina; Pennsylvania; South Carolina; Tennessee; Texas; Virginia; or Washington, DC.
Work Performed
-Applies 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. Focuses on the evaluation and implementation of innovative trial designs to enhance the efficiency and provide better informed decision-making.
-Designs, plans, and executes basic biostatistical components of plans for research and development projects of early-phase clinical studies, including summary statistics of clinical variables and basic inferential statistics.
-Evaluates and understands 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.
-Embraces model-based drug development (MBDD)—a mathematical and statistical approach that constructs, validates, and utilizes disease, placebo, exposure-response, and pharmacometric models to evaluate risk and facilitate drug development, in close collaboration with R&D partners.
-Performs other related duties incidental to the work described herein.
Required Qualifications at this Level
Education/Training: Work requires a minimum of a PharmD, MD, or 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 Phoenix WinNonLin and NONMEM software required.
Ability to assemble and format data using programs such as R, SAS, Stata is a plus.
Duke is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex, sexual orientation, or veteran status.
Duke aspires to create a community built on collaboration, innovation, creativity, and belonging. Our collective success depends on the robust exchange of ideas—an exchange that is best when the rich diversity of our perspectives, backgrounds, and experiences flourishes. To achieve this exchange, it is essential that all members of the community feel secure and welcome, that the contributions of all individuals are respected, and that all voices are heard. All members of our community have a responsibility to uphold these values.
Essential Physical Job Functions: Certain jobs at Duke University and Duke University Health System may include essential job functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department.
External website https://careers.duke.edu/job/Durham-POSTDOCTORAL-ASSOCIATE%2C-DCRI-NC-27710/1091683600/
16th Oct 2023 [3149]
We are looking for a
Research Associate (m/f/d), Pharmacometrics
to join our Section "Data Science and Methods" as soon as possible.
About the Paul-Ehrlich-Institut
We are a senior federal authority responsible for vaccines and biomedicines that performs scientific research in the field of life sciences. Our institute networks with national and international players, which makes it a competent partner for the general public, science, medicine, politics, and economics.
In the Data Science and Methods Section, we support the Institute's divisions by providing mathematical, statistical and pharmacometrics expertise in the fields of regulation and research. A motivated team will support you in the onboarding process. We look forward to working with you. You can expect a position that will present you with diverse tasks and responsibilities involving interdisciplinary project teams.
For further details, please visit our Career page at https://www.pei.de/ (Job ID 1120)
Deadline for applications: 12 November 2023
External website https://www.pei.de/EN/service/career/job-opportunities/job-opportunities-node.html?yid=1120
Contact email address: broseberry@cartermackay.com - 19th Sep 2023 [3148]
Director, Clinical Pharmacology and Pharmacometrics, REMOTE, United States send resume/CV and questions to broseberry@cartermackay.com
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.
Responsibilities Include
- 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: broseberry@cartermackay.com - 19th Sep 2023 [3147]
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.
Responsibilities:
- 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