Senior Director DMPK Search! Our favorite client is expanding rapidly and is need of a DMPK/ADME leader. This role will have direct reports and mentor junior scientists. You'll oversee all aspects of invitro assay development, be responsible for CRO selection and management and champion the preclinical PK aspects of assets throughout the company's portfolio.
You'll need to:
Be onsite at the company's east coast (NJ/PA area) HQ- This is non-negotiable
Have 10+ years experience in industry- in DMPK
Experience in ADME, PBPK, DDI etc.
Please message me to learn more! telder@stem-sourcing.com
External website https://www.stem-sourcing.com
Contact email address: broseberry@cartermackay.com - 11th Jul 2024 [3166]
Associate Director Pharmacometrics role available--large pharma and 4 direct reports--two days a week onsite--hands on about 50% of the time--must have NONMEM--will be leading a small US based group for a large pharma and collaborating with overseas counterparts.
Basic Qualifications:
- Hands on use of NONMEM and R
- Solid knowledge of PK/PD and data analysis
- Execute PMx strategy, and lead teams in data -analysis and interpretation
- Experience in drug development
- Author regulatory documents including study reports, popPK reports, E-R analysis, etc.
- Strong leadership and communication skills
- PhD or PharmD with 5-10 years related experience
External website https://broseberry@cartermackay.com
Contact email address: cornelia.boehnstedt@fu-berlin.de - 7th Jul 2024 [3164]
Call for the next generation of talents 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. 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 (i.e. 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 115 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 115 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 medicine, data sciences or some related field: see https://www.PharMetrX.de.
Deadline for applications: 06 September 2024. Start of Module Curriculum: March 2025
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: broseberry@cartermackay.com - 21st Jun 2024 [3163]
Associate Director, Pharmacometrics role available--hybrid MA or NJ. Please email me for more info at broseberry@cartermackay.com or call my cell 315-415-4353
Main Responsibilities:
- Develop modeling and simulation strategies for optimizing model-informed drug development in all stages of drug development, ranging from first in human dosing through life cycle management.
- Conduct with minimal supervision model-based analyses such as population pharmacokinetics (PPK), PK/PD, exposure response, model-based meta-analysis, clinical trial simulations and disease progression modeling to drive internal pipeline forward
- Conduct innovative quantitative methodologies such as data analytics, machine learning and mechanistic modeling as needed.
- Develop and maintain a comprehensive understanding of global regulatory expectations and best practices for small molecules and biologics, authoring regulatory documents (INDs, CSRs, CTDs), and representing pharmacometrics at regulatory meetings when needed.
- Champion pharmacometrics internal/external visibility (e.g., authoring scientific publications, presentation at national and international conferences, participation in internal cross-functional initiatives, etc.).
- Provide scientific mentoring and support junior scientists and participate in the implementation of best practices within pharmacometrics.
About You:
- Education: Ph.D. with or without post-doctoral experience in Pharmacometrics, Biopharmaceutics, Pharmaceutical Sciences, Mathematics, Statistics, Data Science, Computational Biology, Chemical/Biomedical Engineering, System Pharmacology, Computer Science, or closely related discipline
- Experience: At least 5 years of industrial experience with a record of increasing responsibility and independence
- Deep and extensive modeling experiences ranging from classic translational and population PK modeling, PK/PD modeling, exposure-response modeling, clinical trial simulation, drug-disease modeling, PBPK modeling to advanced complex methodologies such as data analytics, machine learning and mechanistic modeling.
- Proficiency in integrating and analyzing internal and external data to support decision making and to generate scientific insights.
- Extensive experiences in M&S software such as NONMEM, R, Monolix, Phoenix NLME, Matlab, PKsim, SimCYP, Python
External website https://broseberry@cartermackay.com
Contact email address: telder@stem-sourcing.com - 29th May 2024 [3162]
Director or Sr. Director of Clinical Pharmacology and Pharmacometrics-California
Our Client is seeking a highly skilled and experienced Senior Director of Pharmacometrics and Clinical Pharmacology to lead their efforts in early and late-stage clinical drug development (Phase 1-3). The successful candidate will be responsible for designing and implementing pharmacometric and clinical pharmacology strategies that ensure the successful development of innovative therapeutics.
Develop and execute comprehensive pharmacometrics and clinical pharmacology strategies for Phase 1-3 clinical trials.
Oversee the design, execution, and analysis of clinical pharmacology studies, including first-in-human (FIH), dose escalation, bioavailability, bioequivalence, and drug-drug interaction studies.
Ensure timely and accurate interpretation of PK/PD data and its integration into clinical development plans.
Lead the preparation of clinical pharmacology sections of regulatory submissions (INDs, NDAs, BLAs) and represent the company in regulatory interactions.
Lead and mentor a team of pharmacometricians and clinical pharmacologists, fostering a collaborative and innovative work environment.
Proven track record of leading pharmacometrics and clinical pharmacology efforts in the development of novel therapeutics, with successful regulatory submissions. Please message me to learn more
External website https://www.stem-sourcing.com
Contact email address: lijing@wayne.edu - 14th Mar 2024 [3161]
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