JOB PURPOSE
Medicines for Malaria Venture (MMV) 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 12 new medicines that have saved an estimated 1.9 million lives.We are currently seeking an Associate Director, PKPD Modelling and Simulation to join our Translational Medicine team. Reporting to the Director in Pharmacometrics, the Associate Director will help speed up the development of treatment to cure patients from malaria or to protect healthy people from malaria while working in a malaria-endemic zone.
PRIMARY DUTIES AND RESPONSIBILITIES:
- Develop innovative models to help the integration of new data and/or new experiments
- Develop PKPD modelling strategy for MMV projects in late discovery and development, undertake and supervise the delivery of the PKPD modelling across MMV’s therapeutic indications
- Develop and apply modelling solutions for monotherapy and combination therapy
- Summarize, interpret and clarify PKPD results to ensure that valuable scientific information is provided in a timely manner to drive team decisions
- Communicate PKPD modelling strategy and results to project teams, MMV management and regulators
- Contribute to establishing pharmacometrics capabilities and infrastructure (eg development of tools for recurrent and consistent analysis, development and implementation of guidance documents and SOPs within the Pharmacometrics Team)
- Provide pharmacometrics components for submission to regulatory authorities
- 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:
- Ph.D. in Biomedical Science, Pharmacy, Clinical Pharmacology, Biometrics or Computational Engineering
- At least 5 years of 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
- Experience working in a cross-functional matrix
START DATE: As soon as possible
DEADLINE: May 5th, 2019
MORE INFORMATION AND APPLICATION: on https://www.mmv.org/about-us/work-us/jobs#op-318847-associate-director-pkpd-modelling-and-simulation - MMV website
External website https://www.mmv.org/about-us/work-us/jobs#op-318847-associate-director-pkpd-modelling-and-simulation
14th Mar 201 [2934]
SR PHARMACOMETRICS SCIENTIST/DEVELOPMENT SCIENCES @ AXCELLA HEALTH
OVERALL RESPONSIBILITY: br>Axcella Health is seeking a Pharmacometrics Scientist who is well versed in the application of model-based clinical development strategies, in order to describe and understand the pharmacology of our endogenous metabolic modulators. The modeling and simulation activities include population PK/PD models, disease progression models, statistical models, physiologically-based PK (PBPK) models, allometric scaling, quantitative system pharmacology (QSP) models, clinical trial simulations, literature metaanalysis, machine learning/deep learning, and other state-of-the-art quantitative techniques. The candidate will represent the DMPK organization on cross-functional project teams and be an advocate for the use of quantitative approaches to describe the relationship between the known physiology and the observed pharmacokinetics of products.
KEY TASKS AND RESPONSIBILITIES:
- Collaborate with internal and external experts to build population PKPD models for amino acids and contribute to the development of a predictive AXA Development Platform. Our aim is to incorporate drug metabolism and pharmacokinetics knowledge from internal and external sources into a proprietary AXA Development Platform to inform exposure-response relationships and to influence new AXA design.
- Understand and simulate healthy versus disease condition differences to propose dosing regimens for signal seeking studies.
- Undertake diverse scaling approaches to design optimal dosing regimens for pediatric population.
- Conduct biopharmaceutics data analyses (e.g. dissolution performance) with the objective to translate in vitro formulation performance to in vivo formulation performance in humans.
- Organize, execute, and report M&S independently, as well as to present work at crossfunctional teams, department meetings, senior management review committees, regulatory interactions, and scientific conferences.
- Plan, write, and review pharmacometrics aspects in relevant clinical documents such as study protocols, analysis plans, clinical study reports, and regulatory documents.
- Serve as a single point of contact for expert advice on modeling & simulation strategy within Axcella. Collaborate with functions inside and outside of Medical Affairs, including the Product Development Team, to translate available data, summaries, and reports into medical communications and educational resources
- Must have proven experience in quantitative pharmacology and strong hands-on modeling and simulation experience with PK/PD analysis to inform dose selection, safety profile characterization, and product labeling.
- Hands-on experience with population PKPD modeling software (NONMEM, R, SAS, MATLAB, Phoenix, GastroPlus, etc.) is a must.
- In-depth theoretical and applied understanding of PK and PD, in order to describe and understand the pharmacology/biology of amino acids, is required.
- Demonstrated ability to independently plan, organize, and analyze PK/PD data is essential.
- Highly motivated individual with a strong intellectual and technical background in Pharmacometrics discipline
- Excellent problem-solving, written and oral communication skills
Degree in pharmacometrics, pharmacokinetics, pharmacology, pharmaceutical science or related field. PhD with 1- 5 years, or MS with 8+ years of experience in a pharmaceutical industry setting. Experience in modeling/simulation strategies is highly desired. Title/level dependent on experience. If interested, we would welcome a cover letter and CV sent to careers@axcellahealth.com No phone calls please, and only those we will be following up with, will receive a reply
External website https://static1.squarespace.com/static/59c86ca264b05f184cc367e3/t/5c8a5d4e53450a6cd7d01fd1/155257172
14th Mar 201 [2933]
Postdoctoral Fellowship in Pharmacokinetics/Pharmacodynamics
UNC Eshelman School of Pharmacy, University of North Carolina at Chapel Hill
A postdoctoral research position is available immediately to work on projects focused on characterizing the pharmacokinetic/pharmacodynamic properties of drugs used in the pediatric population. The projects will involve use of nonlinear mixed effects and physiologically based pharmacokinetic modeling techniques to identify optimal pediatric dosing and clinical trial design.
Educational requirements: PharmD, MD, or PhD with knowledge of pharmacokinetic/pharmacodynamic analyses.
Preferred experience: demonstrated software proficiency (e.g., NONMEM, R) is preferred. Excellent communication skills and ability to work independently as well as a member of an interdisciplinary team are essential.
Interested applicants should submit a letter describing personal goals as they relate to the position, Curriculum Vitae, and 3 professional references at https://unc.peopleadmin.com/postings/153424.
External website https://unc.peopleadmin.com/postings/153424
Contact email address: gobeaun@mmv.org - 12th Mar 201 [2932]
Job Purpose
Medicines for Malaria Venture (MMV) is hiring a PKPD post-doctoral fellow for 3 years. The position is based in Geneva, Switzerland.
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 post-doctoral fellowship will provide a PhD graduate with the opportunity to expand their scientific knowledge and skills. Working under the direct supervision of a senior pharmacometrician, the successful candidate will have the opportunity to see how pharmacometric approaches (PBPK and PK/PD modeling and simulation) are used to speed up the drug development process, from early to late stage. They will also contribute to the development of innovative modeling approaches to help the interpretation of in vitro data, the translation from preclinical to clinical, and dose selection for clinical studies. Following this experience, the fellow will be well-equipped to accept opportunities in academia, industry or other R&D product development partnership organizations.
Primary Duties and Responsibilities
- Provide PKPD modeling expertise to preclinical and clinical projects to help speed-up the development of molecules for antimalarial treatment or chemoprevention
- PK/PD analyses of non-clinical and clinical studies, especially of combinations of new antimalarial compounds
- Further develop skills in areas such as:
- Preclinical in vitro assays and in vivo experiments used to make first human predictions
- Formulation development
- PBPK analyses
- Clinical development
- 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
More information https://mmv77988.recruiterbox.com/jobs/fk0jdsl
Deadline: 7 April 2019
External website https://mmv77988.recruiterbox.com/jobs/fk0jdsl
Contact email address: broseberry@cartermackay.com - 6th Mar 201 [2931]
Director, clinical pharmacology role available
- Provide global development science and strategic expertise to projects within a specific TA. Provide regulatory expertise for clinical pharmacology registration within a specific TA
- Have thorough understanding of exploratory development, clinical methodologies, POC, and clinical endpoints within a specific TA
- Provide creative clinical pharmacology input for profiling of compounds to enable successful commercial differentiation
- As a global clinical pharmacology lead for phase 3 programs, will ensure efficient delivery of clinical studies within a TA, under the responsibility for registration
- Provides disease area expertise and opportunities for scientific contributions to the team
- Oversees interpretation of complex data, provides leadership in model based drug development, introduces state-of-art translation medicine strategies, platforms and methodologies
- Defines and maintains a leading overall exploratory development and clinical pharmacology strategy.
Provides appropriate clinical pharmacology scientific input on licensing opportunities. - Contributes to the preparation of the capacity and budgetary information related to approved development projects, maintenance and marketing support projects, infra- structural projects and/or departmental activities
- Contributes to the definition, implementation and maintenance of new multidisciplinary ways of working in order to improve the efficiency and effectiveness of clinical pharmacology
- Be the Global Clinical Pharmacology Lead for in-house discovered or in-licensed compounds.
- This requires leading a cross functional team of 15 -- 25 experts in toxicology, pharmacology, translation, Clinical Pharmacology Operations. Responsible for delivery of Exploratory Development strategies to Proof of Concept or Clinical Pharmacology strategies through registration
- Be involved in the design, analysis, and reporting at least 3 to 10 clinical studies per year
- As a clinical pharmacology lead, provide the scientific lead for a cross-functional team of 15 - 25 people
- Responsibilities may directly impact on strategy and efficiency of clinical development of compounds.
- Has responsibilities for contributing to the overall annual budgeting and assessment of resources for assigned projects for executing clinical pharmacology strategy from FIM to registration
- Has responsibilities that directly impacts on strategy and efficiency of clinical development of compounds, especially in the early and late phases.
External website https://www.cartermackay.com
Contact email address: broseberry@cartermackay.com - 5th Mar 201 [2930]
AD/Director Clinical Pharmacology and M&S
Essential Functions:
- The Director of Clinical Pharmacology is accountable for planning and integrating clinical pharmacology studies, which meet standards of excellence, ethical, regulatory, and legal requirements, into overall clinical development program objectives. The Director ensures that clinical pharmacology studies meet agreed timelines and budget and deliver pivotal, decision-making knowledge for the programs.
- Contributes to functional excellence in science, including population modeling and simulation applications in drug development and regulatory science. Maintains contact and establishes strong reputation with the external scientific community through publications and other initiatives.
- Defines resourcing and outsourcing strategy for the operational aspects of clinical pharmacology and external collaborations in modeling and simulation. Directly oversees critical path activities with external artners.
- Manages Associates/Assistants, including responsibility for staff recruitment, development, coaching, mentoring, and performance management.
- Serves as internal consultant for all development teams.
- Defines future directions for Translational Medicine, especially in areas related to novel methodology in clinical science and pharmacometrics.
- A Ph.D. degree in pharmaceutics or Pharm D is preferred.
- 10-15 years+ experience in drug development science, including drug metabolism, PK, PK/PD, biomarkers, writing and regulatory interactions.
- Clinical Pharmacology Study Planning - Thorough understanding and experience in the planning and execution of phase 1 volunteer studies (i.e., clinical trial management of phase 1 studies); Experience with multiple phase 1 units that concentrate in; special populations (elderly, pediatric) RI-AME, First in Man, Impairment, PET/EEG and DDI; Knowledge of clinical pharmacology study requirements including protocol input, CSR?s, and other program documents.
- Cutting-edge knowledge of pharmacometric science and regulatory applications of modeling a simulation in drug development.
- Excellent communication and negotiation skills; Ability to function in a cross-cultural environment.
- Exceptional interpersonal skills (globally, internally and externally).
High level of initiative and ability to work independently under minimal supervision. - Proven ability to support innovation even if taken outside of his/her comfort zone; Demonstrated pragmatism and willingness to drive and support change; Demonstrated ability to challenge established practices and concepts.
Contact email address: broseberry@cartermackay.com - 5th Mar 201 [2929]
Help apply quantitative analysis methods and PK/PD modeling techniques in developing candidate drug products through clinical development. Serve as an expert to all relevant disciplines and ensure that modeling and simulation (M&S) methods are utilized optimally in development activities. Plan and execute PK/PD M&S activities. Represent the Pharmacometrics group in project team meetings, collaborating with others on the principles and theories of quantitative evaluation of new products. In collaboration with other members of project teams, make decisions impacting PK/PD analysis goals and the success and relevance of individual studies. Contribute to the design and preparation of pharmacokinetics development strategies and study protocols, performing and supervising pharmacokinetic and pharmacodynamic analyses, and preparation of clinical study reports and integrated summary documents. Provide feedback and direction for regulatory submission preparations and review support for new or existing products. Work closely with clinical operations, biostatistics, data management, research, drug metabolism, and therapeutics areas. Contribute to the development and implementation of guidelines and SOPs within the Pharmacometrics group. Provide scientific/technical guidance, leadership, and decision-making as appropriate. Provide regular performance feedback, development, and coaching to direct reports.
Requirements: A minimum of PhD in pharmacokinetics/pharmacodynamics, pharmacometrics, or related field is required. A minimum of 8 years of experience in designing, analyzing, and reporting drug development studies is required. Equivalent experience may be accepted.. Proficiency in the use of major PK/PD software such as WinNonlin, Monolix, or NONMEM is required, as is working knowledge of software used to create graphical output and report study results. Strong written and verbal communication skills are required; must be able to independently create high quality written reports and summary documents for use in regulatory submissions. Desire to work in a cross-functional drug development team environment with all levels of employees and management is valued. Must be goal-oriented, quality-conscientious, and project-focused, with demonstrated ability to develop successful influential relationships with colleagues, both internal and external. Please email me at broseberry@cartermackay.com for more info or call at 315-415-4353
Contact email address: broseberry@cartermackay.com - 5th Mar 201 [2928]
Two openings?one in CA one in MA:
Scientist through Associate Director level:
Requirements: A Ph.D. in Pharmacokinetics, Pharmaceutical Sciences, Pharmacology, Biomedical Engineering or related discipline. Level commensurate with experience Relevant PKPD experience and demonstrated impact on drug development and/or the PKPD scientific landscape.
Preferred qualifications: Strong knowledge and experience in either oncology, immunology, and/or tumor immunology are highly desired. Strong knowledge and experience in PK and PK/PD of large molecule therapeutics (e.g., monoclonal antibodies, bispecifics, fusion proteins, antibody-drug conjugates, etc.) are highly desired. Working knowledge of PK/PD software (e.g., WinNonlin, NONMEM, ADAPT II, SimBiology, etc) and the ability to analyze and critically assess PK/PD data is essential.
The candidate should have experience working on cross-functional teams, demonstrate excellent communication skills, and have the ability to work independently and effectively. Please contact me for more info at broseberry@cartermackay.com Upcoming/recent grads/postdocs are welcome to apply
Contact email address: telder@stem-sourcing.com - 5th Mar 201 [2927]
Senior Vice President of Pre-Clinical Development
Specific Responsibilities: Lead the design and implementation of IND and BLA enabling pharmacology, toxicology, pharmacokinetic, and biodistribution studies (GLP and non-GLP) Lead the selection and management of contract research organizations (CROs) to support pre-clinical development programs Drive the continual improvement of pre-clinical development process Work closely with other functional areas and colleagues to ensure that all pre-clinical studies are performed in a quality, timely and scientific manner Write and edit preclinical study reports Participate in preparation for and discussions with regulatory agencies to obtain feedback on pre-clinical development programs Requirements Position Requirements & Experience Expertise in pre-clinical drug development, GMP and FDA requirements Expertise in drug delivery and working with multiple drug target tissues, i.e. skin, retina, bone marrow, brain, liver, lung, etc. Minimum 7 years of management experience Excellent project management and written & oral communication skills Experience with engineered cellular medicines is preferred Scientific degree desired: Ph.D. or M.D. or M.S.., and M.B.A. is a plusExternal website https://www.stem-sourcing.com
11th Feb 201 [2925]
Model Answers R&D is a growing consultancy business dedicated to help pharmaceutical and biotech companies make successful drug development decisions. We continue to expand the team and are looking for an R programmer to support modelling and simulation activities in the company. A brief description of the opportunity can be found below, with more information on the company found on our website (www.model-a.com.au). If you would like to speak to a member of the Exec Team about this position, please contact Mike Cheng (Associate Director - Data Science), or Gillian Corlass (Business Support & Quality Manager). All formal applications must be made via recruitment@model-a.com.au
Role: R programmer with demonstrated experience with R and ability to write well documented reusable code. Tertiary qualification in IT, math or science related field required. Critical thinking, problem solving and analytical skills preferred. Strong communication skills and attention to detail, excellent organisational skills.
Location: Brisbane, Australia
External website https://www.model-a.com.au
Contact email address: annie.lumen@fda.hhs.gov - 1st Feb 201 [2924]
PBPK Modeling Fellowship (ORISE) Division of Biochemical Toxicology National Center for Toxicological Research U.S. Food and Drug Administration Jefferson, AR
Project Description:
A fellowship opportunity is currently available in the Division of Biochemical Toxicology (DBT) at the National Center for Toxicological Research (NCTR) of the U.S. Food and Drug Administration (FDA).
NCTR conducts FDA mission-critical research specializing in the development of scientific strategies to support regulatory decision-making. DBT focuses on fundamental and applied research designed to elucidate mechanisms of toxicity and support risk-assessment for chemicals of interest to the FDA. The selected participant will work with a dedicated mentor on the development and use of pregnancy Physiologically Based Pharmacokinetic (PBPK) models to investigate the challenges and opportunities in modeling life-stages in support of NCTR?s objectives and the FDA mission. Opportunities may include:
- Development of PBPK models for case study compounds to investigate the diverse effects of pregnancy on drug pharmacokinetics.
- Characterizing population variability and propagation of parameter uncertainties in pregnancy PBPK modeling.
- Evaluating the utility of machine learning methods for handling model input specifications.
This program, administered by ORAU through its contract with the U.S. Department of Energy to manage the Oak Ridge Institute for Science and Education, was established through an interagency agreement between DOE and FDA. The appointment is full-time at NCTR in Jefferson, Arkansas. Participants do not become employees of FDA.
Qualifications:
- A Doctoral Degree in pharmacology, toxicology, applied mathematical sciences, chemical engineering, statistics or a related discipline received within the last five years.
- Experience in programming languages and any modeling and simulation software (e.g., R, acslX, MCSim, Berkeley Madonna, Matlab, Simcyp, Gastroplus etc.) and knowledge of pharmacokinetics and toxicological principles is preferred.
To be considered, please send a current CV/resume to the attention of annie.lumen@fda.hhs.gov.
Contact email address: telder@stem-sourcing.com - 1st Feb 201 [2923]
SCIENTIST / SR SCIENTIST ? DMPK CLINICAL PHARMACOLOGY OVERALL RESPONSIBILITY: The DMPK team seeks an experienced Scientist/Sr. Scientist to provide DMPK support to the research and development team. The ideal candidate will be highly skilled in conducting DMPK studies and data interpretation, and characterization of the Axcella products. He or she will serve as a DMPK representative in interdisciplinary collaborations and communicate conclusions, progress, and plans at internal meetings. Hands-on PK/TK analysis, PK/PD, PB/PK or other modeling technique is highly desirable.
KEY TASKS AND RESPONSIBILITIES:
- Incorporate DMPK modeling and simulation capabilities in planned clinical studies
- Independently design, execute and interpret DMPK studies (preclinical and clinical) to investigate PK/PD of AXA amino acids
- Assist in the management of external DMPK (preclinical and clinical) and Toxicology studies by providing tactical resolutions to scientific challenges
- Contribute to PK/PD sections of clinical study protocols and regulatory documents (e.g. IB and IND)
- Study execution and documentation under GxP environment (PK/TK analysis)
- Hands-on PK/TK, PK/PD and PB/PK analysis and prediction using diverse modeling techniques (Phoenix, G+, Simcyp, R, NONMEM, etc.)
- Highly motivated individual with a strong intellectual and technical background in DMPK/Clinical Pharmacology discipline
- Proven ability to independently perform high quality research and work effectively on multifunctional teams
- Experience in the conduct of early clinical studies from PK perspective is highly desired
- Excellent problem-solving abilities
- Excellent written and oral communication skills
External website https://www.stem-sourcing.com
Contact email address: telder@stem-sourcing.com - 29th Jan 201 [2922]
Associate Dir. or Dir. of Clinical Pharmacology/Pharmacometrics
Well established company looking for AD or Dir of Clinical Pharmacology with previous hands on experience with pop pk (NONMEM). This candidate will manage pop pk CRO\\\'s and have oversight of modeling studies while not actually being responsible for M&S on-site. Ph.D with 10+ years of experience. Senior Director title is not an option for this role.External website https://www.stem-sourcing.com
Contact email address: telder@stem-sourcing.com - 23rd Jan 201 [2921]
Sr. Dir. Clinical Pharm/DMPK
Key Responsibilities
Responsible for scientific and budgetary responsibility for the design, execution, analysis, interpretation and reporting of clinical pharmacology related studies including first-in-human, drug-drug interaction, biopharmaceutics and ADME studies. Develop and execute clinical pharmacology strategies in collaboration with internal and external partners to advance drug candidates in an efficient and scientifically rigorous manner. Lead cutting edge science, creativity, and novel approaches in clinical pharmacology and related areas. Lead and develop a team of Clinical Pharmacologists, in addition to providing oversight for work conducted by CROs. Represent clinical pharmacology in project teams and in regulatory interactions including preparation of regulatory documentation and participation in meetings with regulatory agencies. Minimum Requirements
PhD in clinical pharmacology, pharmaceutical sciences or related areas such as pharmacokinetics, pharmacology or drug metabolism with at least 12 years of relevant experience in drug development. Exceptional Masters or Bachelor?s candidates with demonstrated proven experience will be considered. Must demonstrate the aptitude and experience to lead a clinical pharmacology group and effectively manage professional staff. Extensive experience in formulating and executing clinical development strategies including design, interpretation and reporting of clinical pharmacology studies is required. A working knowledge and previous experience with pharmacokinetic/pharmacodynamics, drug-drug interactions, PKPD data management/analysis, and experimental medicine is also needed. Broad familiarity with the drug development process, particularly for oncology, is highly desirable as is prior experience working with CROs.
External website http://www.stem-sourcing.com
Contact email address: lgraham@kinderpharm.com - 23rd Jan 201 [2920]
Associate Director Pharmacokinetics / Pharmacokinetic Scientist Department: Pharmacokinetics Location: Exton, Pennsylvania Contact: Lynda Graham, MBA lgraham@kinderpharm.com
Who We Are
Synteract is a global full-service contract research organization with a successful three-decade track record supporting biotechnology, medical device and pharmaceutical companies. With our mission of ?Bringing Clinical Trials to Life,? we provide customized Phase I through IV services internationally, offering expertise across multiple therapeutic areas including notable depth in Oncology, Neuro Degenerative Diseases, and Rare and Orphan Diseases, and in pediatric populations. Our mission is to support the innovation and development of better therapies in healthcare.
Position Overview Conduct PK/PD modeling and population PK analyses using WinNonLin, NonMem and PK-Sim with a focus on designing optimal dosing regimens for pediatric patients and other special patient populations. Provide pharmacology, pharmacokinetic consulting to clients with a specialization on pediatric patient populations. Design, analyze and report pre-clinical and clinical pharmacokinetic, PK/PD modeling and trial simulation studies. Be the subject-matter expert on pediatric dosing methodologies including allometric scaling approaches.
Job Duties & Responsibilities
- Conduct PK/PD analyses, modeling and simulation in WinNonLin, NonMem and PK-Sim for pediatric patients other special patient populations requiring dose regimen modification.
- Assist clients in the design and development of pre-clinical and clinical protocols with respect to toxicokinetic and pharmacokinetic analyses
- When the lead PK Scientist on assigned projects, act as the project manager to include functioning as the principal liaison with key clients, vendors, and internal team members.
- When the lead PK Scientist, will create trust and confidence amongst clients, vendors and team members while delivering on-time, and on-budget programs that leverage the various resources, expertise and cross function knowledge available within Synteract.
- Work with client?s data management group to prepare datasets for import and analysis in WinNonLin.
- Conduct non-compartmental (NCA) and compartmental PK analysis is Phoenix WinNonLin-PKSo.
- Responsible for locking and unlocking studies/scenarios in the PKSo database following management authorization.
- Writing stand-alone PK reports and PK study report sections for CSR?s
- Responsible for ensuring study data and study reports are retained according to the corporate records retention policy.
- Ensuring corporate quality policies and SOPs are followed during the analysis and reporting of PK studies
- Provide pharmacology, pharmacokinetic and drug development consulting services to clients with a specialization in pediatric drug development.
- Ph.D. in Pharmacokinetics or Pharmaceutical Sciences
- Non-compartmental (NCA) and compartmental PK analysis is Phoenix WinNonLin-PKSo
- Knowledge of how to support pediatric Pharmacokinetic/Pharmacodynamic modeling and simulations as follows:
- PK/PD analyses, modeling and simulation in WinNonLin
- Population PK using NonMem
- Physicological Based PK using PKSim, GastroPlus or SimSyp
- Pediatric knowledge can be gained concurrently through Ph.D. program, as a postdoctoral fellow, or in a professional position
- 10% domestic travel to meetings/conferences/client sites.
Synteract?s policy is to provide equal employment opportunity and affirmative action in all of its employment practices without regard to race, color, religion, sex, national origin, ancestry, marital status, protected veteran status, age, individuals with disabilities, sexual orientation or gender identity or expression or any other legally protected category. Applicants for positions with Synteract must be legally authorized to work in the country which they are applying and verification of employment eligibility will be required as a condition of hire.
External website http:// kinderpharm.com
Contact email address: jdumond@unc.edu - 18th Jan 201 [2919]
A Research Assistant Professor position is available immediately to work as part of a multidisciplinary team on infectious disease projects focused on the application of mathematical modeling and simulation to characterize drug pharmacokinetics and pharmacodynamics. The projects will involve the use of nonlinear mixed effects and physiologically-based modeling techniques, and other biostatistical applications in preclinical and clinical drug development research, to identify optimal dosing and clinical trial design. The successful candidate will work in the Clinical Pharmacology and Analytical Chemistry Laboratory of Dr. Angela Kashuba, and will focus on challenging preclinical and clinical modeling projects in the areas of HIV treatment, prevention, and cure. This position is also integrated into the UNC Center for AIDS Research, the HIV Cure Center, and Qura Therapeutics. The candidate will also consult on, and assist with, projects supported by these entities. This candidate will become part of the Division of Pharmacotherapy and Experimental Therapeutics. This Division is a designated Pharsight Phoenix® Center of Excellence, and is a nationally recognized, dynamic and collegial faculty whose vision is to lead the nation in achieving excellence in innovative translational research, education, and progressive pharmacy practice to optimize drug therapy outcomes.
The Division has vibrant fellowship and graduate programs, including an NIH-funded T32 postdoctoral training program in Clinical Pharmacology in collaboration with Duke University and the Institute for Drug Safety Sciences. It is expected that the successful candidate will embrace student mentoring. Didactic teaching is not required, but there are many opportunities to participate if the candidate wishes to grow their teaching portfolio. At UNC-CH, the UNC Schools of Medicine, Public Health, Dentistry, Nursing and Pharmacy comprise one of the nation?s few comprehensive academic health centers located on a world-class research campus. This creates an excellent environment in which to conduct multidisciplinary research. This position will work within dynamic multidisciplinary teams to optimize drug dosing and outcomes.
Qualified candidates must have either a doctoral degree in Pharmacometrics, Pharmaceutical Sciences, Biostatistics, Biomedical Engineering, Medicine, Pharmacy or a closely related discipline, or a masters of science degree with additional pharmacometrics training. The successful candidate must demonstrate expertise in modeling, simulation, and statistical methods through evidence of scientific meeting presentations, publications, regulatory report submissions or other equivalent activities.Extensive software (e.g., NONMEM, ADAPT, Phoenix, Simulations Plus Suite, R) and programming proficiency is preferred. Excellent communication skills and ability to work independently as well as a member of an interdisciplinary team are essential. Interested applicants should submit a letter describing personal goals as they relate to the position, along with a curriculum vitae.
External website https://unc.peopleadmin.com/postings/154869
17th Jan 201 [2918]
UNC/GSK Postdoctoral Fellowship in Pharmacokinetics/Pharmacodynamics
The UNC Eshelman School of Pharmacy and GlaxoSmithKline (GSK) offers a two-year postdoctoral fellowship in pharmacokinetics/pharmacodynamics (PK/PD). The fellowship emphasizes coursework and hands-on experience focused on the application of population and physiologically-based PK/PD modeling and simulation techniques to guide drug development. Fellows spend their first year in Chapel Hill, NC at the University of North Carolina, and the second year at GSK research facilities in Collegeville, PA.
At the completion of the Fellowship, the post-doctoral fellow will be able to:
- Describe the importance of clinical research in drug development;
- Describe the nature and relevance of clinical data evaluations relative to drug development;
- Design and implement studies to examine drug absorption, drug disposition, pharmacodynamic endpoints and drug interactions in healthy human volunteers or diseased patient populations;
- Understand foundational concepts related to population PK/PD and physiologically-based PK modeling and simulation techniques;
- Understand important considerations in clinical trial design and the conduct of clinical investigations in specific patient populations (e.g., pediatrics);
- Perform PK/PD and statistical data analysis using relevant software packages;
- Prepare a manuscript, seminar and other scholarly vehicles for communication of scientific results.
External website http://pharmacydpetfellowships.web.unc.edu/
Contact email address: valva@cop.ufl.edu - 16th Jan 201 [2917]
Job description: The Center for Pharmacometrics and Systems Pharmacology (CPSP) in the Department of Pharmaceutics (PC) at the University of Florida College of Pharmacy (COP) on the Lake Nona (Orlando) campus invites applications for a Postdoctoral Research Fellow position. The successful applicant will have demonstrated expertise in Quantitative Clinical Pharmacology and will join the CPSP to develop state-of-the art mechanistic models. Demonstrated experience in system pharmacology and/or physiologically-based pharmacokinetic modeling and population pharmacokinetics/pharmacodynamics will be considered as an advantage.
The Center?s mission is to advance drug development and regulatory science through innovative translational research, education and scientific multidisciplinary collaborations with industry, FDA, NIH, academia, foundations, and other public entities, with a focus on biosimulation.
Minimum Requirements: The successful applicant will hold a Ph.D. with training in applied quantitative clinical pharmacology. FDLE Criminal Background Check Required.
Preferred Qualifications: The successful applicant will have experience in the area of systems pharmacology and/or PBPK and/or pop PK/PD modeling and simulation. Soft skills are essential to team-based research, and in order to provide clear verbal and written communication between, trainees, faculty, and external collaborators. Regulatory or industry experience is an added attribute for the successful candidate provided that a thorough understanding of drug development and regulatory decision making process is helpful for successfully working in the highly collaborative environment of the Center and its partners.
Special Instructions to Applicants: The Search Committee will accept applications until the position is filled. Application will be reviewed starting end of January, 2019. Interested applicants should apply by email at valva@cop.ufl.edu and submit: (1) a letter of interest; (2) complete curriculum vitae; and (3) contact information for at least three professional/academic references. Three letters of recommendation will be required for final candidates.
Questions may be directed to Valvanera Vozmediano, valva@cop.ufl.edu.
Contact email address: lwilken@lilly.com - 15th Jan 201 [2916]
At Lilly, we unite caring with discovery to make life better for people around the world. Due to strategic dedication to the growth of biotechnology, we are seeking an experienced ADME scientist to work in a highly collaborative team environment. Are you looking to grow in your career and contribute at a high level to our strong pipeline of therapies? Can you apply your diverse analytical tools to characterize and optimize factors influencing the absorption, disposition, and pharmacodynamic properties of biologic therapeutics in development as drug entities? The Biotechnology Research/ADME team works closely with toxicology, discovery biology, protein engineering and multiple therapeutic areas as part of a collaborative effort to advance peptides, proteins, and monoclonal antibodies to clinical testing. Lilly offers a unique and dynamic research environment where our teamwork and contributions are valued and recognized. Our patients are waiting. Are you interested in leading key research that will make an impact on the lives of people around the world?
In this role you will be responsible for:
Oversight of study design and execution for non-clinical PK and PK/PD studies, TK studies. Function as a project leader in a multidisciplinary team environment with primary responsibility for the early preclinical development of antibodies and protein molecules. Integrate pharmacokinetics and PK/PD with discovery biology to define structure activity relationships guiding protein engineering strategies and optimization of protein therapeutics. Interact across groups, including other departments, regulatory agencies, and functional teams within drug disposition. Lead preparation of relevant sections of regulatory documents for development and registration of new drugs and line extensions; interact with regulatory agencies worldwide. Lead, coach and mentor the technical work of junior scientists. Collaborate with scientists in academia. Excellent written and oral communication of scientific data, both internally and in the scientific community
Company Overview
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 39,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We?re looking for people who are determined to make life better for people around the world.
Basic Qualifications
Ph.D. in Biochemistry/Biology/Cell Biology or a related discipline in Pharmaceutical Sciences. At least 5 years of experience in the development of monoclonal antibodies, peptides/proteins or fusion proteins preferably in industry (Pharma/Biotech).
Additional Information
Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
Additional Skills/Preferences
Experience with oral protein delivery strategies, development and implementation of animal models for oral peptide delivery. Industry (pharma, biotech, CRO, etc.) experience with PK/PD modeling. Working knowledge of immunoassay and/or LC/MS bioanalytical methodology. Experience with drug development and knowledge of regulatory processes. Working in an interdisciplinary team. Proven ability to identify scientific issues and tackle problems, both individually and with collaborators in other functional areas. Ability to influence, negotiate and communicate with partners in both internal and external organizations.
External website http://bit.ly/45806_Lilly
17th Dec 201 [2915]
Postdoctoral Fellowship in Pharmacokinetics/Pharmacodynamics
UNC Eshelman School of Pharmacy University of North Carolina at Chapel Hill
A postdoctoral research position is available immediately to work on projects focused on characterizing the pharmacokinetic/pharmacodynamic properties of drugs used in the pediatric population. The projects will involve use of nonlinear mixed effects and physiologically based pharmacokinetic modeling techniques to identify optimal pediatric dosing and clinical trial design.
Educational requirements: PharmD, MD, or PhD with knowledge of pharmacokinetic/pharmacodynamic analyses.
Preferred experience: demonstrated software proficiency (e.g., NONMEM, R) is preferred. Excellent communication skills and ability to work independently as well as a member of an interdisciplinary team are essential.
Interested applicants should submit a letter describing personal goals as they relate to the position, Curriculum Vitae, and 3 professional references at https://unc.peopleadmin.com/postings/153424.
External website https://unc.peopleadmin.com/postings/153424
Contact email address: mehvar@chapman.edu - 14th Dec 201 [2914]
A Post-doctoral position is available in the Department of Biomedical and Pharmaceutical Sciences at Chapman University School of Pharmacy in Irvine, California. The specific research includes the use of small animal models to study the effects of liver diseases on the transporter- and/or cytochrome P450-mediated hepatobiliary and brain disposition of drugs. Candidates with a Ph.D. degree in Pharmaceutical Sciences or related areas with interest in the areas of pharmacology/pharmacokinetics/drug metabolism will be considered. Additionally, the position requires prior experience with surgical procedures in rodents and analytical methods, such as LC/MS/MS, demonstrated by strong peer-reviewed publications. Excellent oral and written communication skills and ability to work independently or as part of an interdisciplinary team are essential. The successful candidate will work in a new research facility, which is equipped with the state-of-the-art research equipment.
Qualified applicants should submit a curriculum vitae, summary of research interests, and names/titles and contact information of three references electronically to Dr. Reza Mehvar (mehvar@chapman.edu). Review of applications starts immediately and will continue until the position is filled. The position is available on Feb. 1, 2019.
Chapman University is an equal opportunity employer committed to fostering a diverse and inclusive academic global community. The University is dedicated to enhancing diversity and inclusion in all aspects of recruitment and employment. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, gender expression, national origin, ancestry, citizenship status, physical disability, mental disability, medical condition, military and veteran status, marital status, pregnancy, genetic information or any other characteristic protected by state or federal law. The University is committed to achieving a diverse faculty and staff and encourages members of underrepresented groups to apply.
External website https://www.chapman.edu/our-faculty/reza-mehvar
Contact email address: piet.swart@nuvisan.com - 16th Nov 201 [2912]
NUVISAN Pharma Services is looking for a Lab Head in vivo DMPK We are looking for a highly motivated in-vivo DMPK lab head to join our Nuvisan DMPK team in Grafing near Munich. You will act as study director for our in vivo DMPK studies and provide DMPK expertise to our client pre-clinical development plans and supervise the in house laboratory animal studies. Together with management you will develop the organization into a high quality and leading European pre-clinical DMPK service site. If you are someone with excellent experiences in conducting in-vivo laboratory animal studies (rodents and non-rodents) this role might be a great opportunity for you.
IN THIS POSITION, YOU WILL BE RESPONSIBLE FOR
- Leading a non-clinical in vivo DMPK lab staffed with 2-3 bench scientist
- In the role of Study Director / Principal Investigator take responsibility for the design, planning, execution and reporting of non-radioactive and radioactive pre-clinical ADME and PK studies for small and large molecule, if necessary according to GLP standards
- Conduct interim DMPK analyses, interpret the data and attend client meetings to discuss study progression
- Assume responsibility as deputy principal investigator according to German animal welfare laws for all animal studies Responsible for compliance with German law, GLP, GCP, guidelines and other applicable regulation (e.g., radio protection) pertaining to the R&D process, study conduct, and registration of drugs
- Responsible (and accountable as per delegation) for and enforce adherence to safety measures in laboratories
- University degree in the field of veterinary medicine, biology, pharmacy or equivalent natural sciences
- At least 5 years professional experience in DMPK within a pharmaceutical environment
- At least 3 years? experience in acting as responsible person for animal experiments and communication with respective authorities
- In-depth knowledge of ADME principles and working knowledge of mouse and rat anatomy
- Hands on experience with in vivo studies rodents and dogs
- Active license FELASA C
- Experience in handling radioactive compounds
- Experience with Phoenix WinNonlin
- Experience in conduct of GLP compliant studies ?
- Experience in authoring study reports and submission relevant dossiers
- Qualification as principal investigator according to German animal welfare laws
- Native speaker German and Fluent in English (written and spoken) The NUVISAN Group is an internationally successful Contract Research Organisation (CRO) which performs drug trials for international pharmaceutical companies, biotech and generic manufacturers.
External website https://www.nuvisan.com/career.html
Contact email address: shori@stanford.edu - 3rd Nov 201 [2911]
Open Postdoctoral position, faculty mentor Sharon Hori, PhD
One Postdoctoral Fellow position is available immediately in the Molecular Imaging Program at Stanford (MIPS), Stanford University School of Medicine. The successful candidate will join a dynamic and interdisciplinary research group focusing on the early detection of breast cancer using approaches in experimental biology, transgenic mouse models, and computational/mathematical modeling. This position will be jointly based in the highly collaborative laboratories of Dr. Sharon Hori, Dr. Ramasamy Paulmurugan, and Dr. Sanjiv Sam Gambhir.
Required Qualifications
- Our diverse team is looking for a motivated, ambitious, and creative scientist with excellent written and verbal communication skills.
- The successful applicant must have a PhD, MD, or MD-PhD with expertise in preclinical cancer animal models, molecular biology, or mathematical modeling.
- A strong desire to learn firsthand how to conduct highly integrative biological (wetlab) and computational (drylab) cancer studies.
- Preference will be given to candidates with a background in any of the following: transgenic mouse model development, cancer biomarker assay development, microRNA biology, preclinical in vivo optical and molecular imaging, mathematical modeling of cancer (or other diseases), pharmacokinetics/pharmacodynamics, and machine learning.
- Successful applicants will have a track record of productive research and publications.
- Applicants in the fields of Molecular Biology (and other Biology), Cancer Biology, Computer Science, Computational Biology, Systems Biology, Biomedical Engineering (and other Engineering), Biostatistics, and related fields are encouraged to apply.
- Computational researchers with a limited biology background (but strong interest in learning wetlab techniques) and biologists with mathematical, computational, or programming experience are strongly encouraged to apply.
Required Application Materials
- CV
- A brief statement of interest and career goals
- Names and contact information of three referees
Stanford is an equal opportunity employer and all qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other characteristic protected by law.
External website https://stanford.io/2QhZU5V
26th Oct 201 [2910]
We?re looking to hire a Drug Metabolism PK/PD Specialist to join us in our mission to design drugs that improve human health and materials that increase quality of life!
Schrödinger is on the cutting edge of computer-aided drug discovery and materials science, collaborating with companies like Takeda, Nimbus, Pfizer, and Sanofi. We hold the record for the largest and fastest cloud computing run (156,000 cores!), and our software suites continue to revolutionize the design of therapeutics and materials. WaterMap, Maestro, and LiveDesign are just a few examples of the programs we?ve created.
As a member of our Drug Discovery team, you?ll join over 60 designers, modelers, computational chemists, medicinal chemists, crystallographers, and biologists in an environment that is supported by a large-scale compute infrastructure and over 100 developers. You?ll supervise drug candidate design, define differentiation strategies, determine drug disposition mechanisms and target pharmacology, interpret toxicokinetic profiles, and establish human dose predictions. In the last seven years, four of the programs we?ve worked on have reached the clinic; we need you to help us advance the next drug candidate.
Who will love this job:
--An accomplished PK/PD modeler who has a deep understanding of and appreciation for pharmacokinetic and pharmacodynamic principles
--An eager student of biological sciences who?s willing to build on a solid foundation of quantitative skills to develop mechanistically-relevant PK/PD models
--An experienced manager of external studies at CROs who can monitor study execution and ensure finalization of study reports within set timelines
--An interdisciplinary self-starter who?s comfortable working across a number of disease areas and shifting gears quickly
--An outstanding presenter
What you?ll do:
--Manage ADME data generation and interpretation for drug discovery programs
--Make human dose predictions through empirical and/or model-based interspecies scaling of PK/PD
--Develop predictive mechanistic pharmacology models to guide discovery teams to select appropriate compounds and molecular targets
--Aid biologists and experimentalists in implementing emerging methodologies and technologies with respect to the design, execution, and interpretation of in vitro and in vivo pharmacology studies
--Participate in multidisciplinary team efforts to make decisions on compound and program progression
--Provide scientifically sound approaches and data integration for effective decision-making and enable advancement of drug candidates into clinical development
What you should have:
--PhD in pharmacokinetics or related field
--At least eight years of experience in drug discovery
--Experience in translational research, IND-enabling studies, and/or early clinical development
Pay and perks:
Schrödinger understands it?s people that make a company great. Because of this, we?re prepared to offer a competitive salary, stock options, and a wide range of benefits that include healthcare (with dental and vision), a 401k, pre-tax commuter benefits, a flexible work schedule, and a parental leave program. We have catered meals in the office every day, a company culture that is relaxed but engaged, and over a month of paid vacation time. Our Administrative and Human Resources departments also plan a myriad of fun company-wide events - last summer we went tubing down the Delaware River! New York is home to our largest office, but we have teams all over the world.
Sound exciting? Apply today and join us!
As an equal opportunity employer, Schrödinger hires outstanding individuals into every position in the company. People who work with us have a high degree of engagement, a commitment to working effectively in teams, and a passion for the company?s mission. We place the highest value on creating a safe environment where our employees can grow and contribute, and refuse to discriminate on the basis of race, color, religious belief, sex, age, national origin, citizenship status, marital status, union status, sexual orientation, or gender identity. To us, ?diversity? isn?t just a buzzword, but an important element of our core principles and key business practices. We believe that diverse companies innovate better and think more creatively than homogenous ones because they take into account a wide range of viewpoints. Greater diversity doesn?t just mean better headlines or public images?it means increased adaptability and profitability.
External website http://https://hire.withgoogle.com/public/jobs/schrodingercom/view/P_AAAAAADAADpCPh17M9IFaB
Contact email address: Cynthia.j.musante@pfizer.com - 24th Oct 201 [2909]
Quantitative Systems Pharmacology (QSP) is a discipline that uses mechanistic mathematical models and disease platforms to enhance the robustness and quality of decision-making from exploratory research through clinical development. We are seeking highly motivated individuals to lead the development and application of QSP models for the in silico evaluation of novel targets and compounds, including preclinical and clinical study design and mechanistic interpretation of results. Successful candidates will be responsible for integrating and sharing data and knowledge in a highly stimulating, collaborative, and multi-disciplinary environment to develop a deeper understanding of physiological systems and disease mechanisms across different therapeutic areas.
We have several open positions at varying levels of experience, from entry level to experienced modelers. For more information, please search our careers site for the following Job IDs:
Senior Scientist: 4720440 Principal Scientist: 4720438 Senior Principal Scientist: 4720439
External website http://www.pfizer.com/careers