PK/PD and Other Jobs

The URL for this page is http://www.pharmpk.com/pkjob.html

Add your own entry?


21st Jun 201 [2946]

PK/PD Postdoctoral Research Associate

Location: University of North Carolina at Chapel Hill, Eshelman School of Pharmacy

Job Description: A Postdoctoral Research Associate position is available immediately to work on projects focused on characterizing the pharmacokinetic/pharmacodynamic properties of Direct Oral Anticoagulants (DOACs). Eventually, work on other therapeutic areas will also be involved. The projects will involve use of nonlinear mixed effects and physiologically based pharmacokinetic modeling techniques to identify patients that require dose adjustment and individualization.

Educational Requirements: PharmD, MD, or PhD.

Qualifications and Experience

Equal Opportunity Employer

The University of North Carolina at Chapel Hill is an equal opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to age, color, disability, gender, gender expression, gender identity, genetic information, race, national origin, religion, sex, sexual orientation, or status as a protected veteran.

Required Documents

Curriculum Vitae /Cover letter /List of References

External website https://unc.peopleadmin.com/postings/159679


Contact email address: robstrat@iu.edu - 19th Jun 201 [2945]

A two-year postdoctoral fellowship in the Disease and Therapeutic Response Modeling and A two-year post-doctoral fellowship is available within the Disease and Therapeutic Response Modeling and Simulation Program, Division of Clinical Pharmacology, Department of Medicine at the Indiana University School of Medicine. The postdoctoral fellow will join our individualized training program in quantitative clinical pharmacology and pharmacometrics, including application of non-linear mixed effects modeling, physiological-based pharmacokinetic modeling, data mining, machine learning, and quantitative systems pharmacology. Trainees will benefit from interactions with the Division’s T32 Clinical Pharmacology Fellowship program, experts in clinical pharmacology, biostatistics, computational biology, and bioinformatics, as well as faculty with long-term experience in the pharmaceutical industry. Candidates will develop the critical skills necessary for participation in state-of-the-art pharmaceutical research, including support of the Preclinical Trial Core of the MODEL-AD Alzheimer’s disease research program. Additionally, the candidate will have the opportunity to support projects in other therapeutic areas of interest, including women’s health, oncology, pediatrics, nephrology, psychiatry, and mechanistic modeling of drug-drug interactions. Candidates are also encouraged to pursue methodological topics relevant to clinical interests of the Program.

Basic Qualifications
Our interdisciplinary team is looking for a motivated, ambitious and creative individual with excellent written and verbal communication skills.
PharmD, MD, or PhD in pharmacology, systems biology/pharmacology, pharmacometrics, bioengineering, biostatistics, computational biology, or related fields.
Preference will be given to candidates with strong quantitative skills and computational experience (R, Matlab, Python, Nonmem, etc); however, candidates with a strong desire to integrate such analyses with pre-clinical and/or clinical drug studies are also encouraged to apply.

External website https://indiana.peopleadmin.com/postings/7843


17th Jun 201 [2944]

Your Role:

The Head of Global DMPK:

Provides strategic impact through: Who You Are: Hear more about the role here: https://video.creace.io/17eeH-1DhX

Apply Here: https://bit.ly/2tFVDzv

External website https://bit.ly/2tFVDzv


Contact email address: telder@stem-sourcing.com - 7th Jun 201 [2943]

Director Pharmacometrics

Well established company looking for director and future head of the clinical pharmacology and pharmacometrics department. This role will be an individual contributor primarily in M&S but will have the opportunity to mentor and train junior scientists.

This company is working with small molecules, large molecules, SiRNA, and monoclonal antibodies.

Let me know if you'd like to learn more.

External website https://www.stem-sourcing.com


Contact email address: Cassie.Hauser@synteract.com - 3rd Jun 201 [2942]

Senior Pharmacokinetics / Pharmacokinetic Scientist - Anywhere, US Office-based or Remote-based

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
The Senior Pharmacokinetics / Pharmacokinetic Scientist conducts PK/PD modeling and population PK analyses using WinNonLin, NonMem and PKSim 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.

Specific tasks would include:
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.

Qualifications:
Ph.D. in Pharmacokinetics or Pharmaceutical Sciences, plus knowledge of how to support pediatric Pharmacokinetic/Pharmacodynamic modeling and simulations, specifically population PK. 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 If you’re passionate about bringing clinical trials to life, we encourage you to apply today!

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. The Company will not sponsor applicants [to this position] for work visas.

External website https://www.synteract.com/Careers/Career-Opportunities?gnk=job&gni=8a78879e69b7f0180169bb663e5f1e66


Contact email address: mark.leggas@uky.edu - 28th May 201 [2941]

Colleagues,

The University of Kentucky Department of Pharmaceutical Sciences is recruiting a postdoctoral scholar in pharmacokinetics/pharmacology. The postdoc will participate in an exciting drug development project to further the development of lead drug candidates for the treatment of Ewing Sarcoma. The project involves both research efforts and pre-IND activities. The position seeks a trainee whose primary expertise are in Pharmacokinetics and Drug Metabolism but is willing to extend her/his skillset and incorporate other pharmacology studies such as tumor xenografts for efficacy assessment. Expertise in bioanalytical methods are also desirable but not critical. The post-doc will perform sample preparation, LC-MS instrument maintenance and operation to acquire highly reproducible data and metabolite identification. They will contribute to study design and/or conduct of animal experiments and will perform PK/PD modeling and statistical analysis. The post-doc is expected to work independently but will interface with the PI, senior graduate students, staff, and collaborators.

External website http://ukjobs.uky.edu/postings/220976


Contact email address: zhoumeng@ksu.edu - 27th May 201 [2940]

Job Description: Two postdoc opportunities in PBPK Modeling, Risk Assessment, and Computational Toxicology are available at Kansas State University. The incumbent of the first position will work with Dr. Zhoumeng Lin on PBPK modeling projects at K-State in the first year, and then will move to University of California at Davis to receive additional training in experimental animal techniques and analytical chemistry methods under the mentorship of Dr. Lisa Tell in the second year. The second position will work with Dr. Zhoumeng Lin at K-State on projects related to PBPK modeling, risk assessment and computational toxicology. A PhD in pharmacometrics, pharmacology, toxicology, epidemiology, environmental health, engineering, biostatistics, bioinformatics, or a related field is required.

How to Apply: Please refer to the following webpages for detailed job description and application instructions. Position 1: http://careers.k-state.edu/cw/en-us/job/507327/fellow-post-doc-anatomy-physiology. Position 2: http://careers.k-state.edu/cw/en-us/job/507326/fellow-post-doc-computational-toxicology-pharmacokinetic-modeling. Screening of applicants begins on June 28, 2019 and will continue until the position is filled.

Questions: Please send your inquiry with a copy of updated CV to Dr. Zhoumeng Lin at Zhoumeng@ksu.edu. For more information about Dr. Lin’s research and teaching, please visit his laboratory website (http://www.vet.k-state.edu/education/anatomy-physiology/faculty-staff/faculty/lin/lab/index.html).

Kansas State University is an equal opportunity employer and actively seeks diversity among its employees. Background check is required.

External website https://http://www.vet.k-state.edu/education/anatomy-physiology/faculty-staff/faculty/lin/lab/join_us.html


Contact email address: telder@stem-sourcing.com - 15th May 201 [2939]

Sr. Scientist or Principal Scientist

My client is looking for a clin pharm scientist to work on anti-body programs for oncology. Responsibilities:

Requirements:

External website https://www.stem-sourcing.com


Contact email address: telder@stem-sourcing.com - 7th May 201 [2938]

Head of DMPK

Small company is looking for a Head of DMPK that is well versed in early stage oncology programs. The incumbent will work primarily with CRO's and provide strategic oversight for all things ADME & DMPK. Incumbent will have full oversight of outsourced PK/PD modeling and simulations.

Small molecule experience is essential and antibody experience is an added bonus. Extensive knowledge of regulatory requirements and GLP, GCP and ICH experience is necessary to be successful in this role.

Please let me know if you'd like to learn more about this exciting opportunity.

External website https://www.stem-sourcing.com


23rd Apr 201 [2937]

PK/PD Postdoctoral Associate

Location: University of North Carolina at Chapel Hill, Eshelman School of Pharmacy

Job Description: A research scientist position is available immediately to work on projects focused on characterizing the pharmacokinetic/pharmacodynamic properties of Direct Oral Anticoagulants (DOACs). Eventually, work on other therapeutic areas will also be involved. The projects will involve use of nonlinear mixed effects and physiologically based pharmacokinetic modeling techniques to identify patients that require dose adjustment and individualization.

Educational Requirements: Pharm.D, MD, or PhD. Salary Range: Dependent on experience and qualifications

Qualifications and Experience

Required Documents Curriculum Vitae /Cover letter /List of References

External website https://unc.peopleadmin.com/postings/159679


Contact email address: telder@stem-sourcing.com - 18th Apr 201 [2936]

Senior Director, Clinical Pharmacology
Job Description
The Senior Director of Clinical Pharmacology will serve as the Clinical Pharmacology representative on project teams, providing strategic leadership and execution of clinical pharmacology plans that characterize the pharmacokinetic (PK) and pharmacodynamics (PD) properties and drug-exposure relationships for the purpose of optimizing drug regimens. By integrating PK, PD, pharmacogentic, demographic and disease knowledge, the individual will be critical in optimizing and driving insightful drug development plans.
Principal Accountabilities:

Job Requirements
Skills:

External website https://www.stem-sourcing.com


Contact email address: gobeaun@mmv.org - 17th Apr 201 [2935]

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:

EDUCATION AND EXPERIENCE:

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:

SKILLS AND ATTRIBUTES: EDUCATION AND EXPERIENCE:
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

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

Essential Job Responsibilities: please contact me for more information. This role can be home based

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:

Education level and/or relevant experience(s): Knowledge and skills (general and technical):
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 plus

External 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:

Through this fellowship, the selected participant will have the opportunity to learn and apply computational modeling skills to address public health-related issues and gain experience in developing tools geared towards the advancement of regulatory science. S/he will collaborate with FDA investigators at NCTR and with investigators in other FDA centers. During the project, s/he will be actively encouraged to present the research at internal and external meetings and publish the findings in peer-reviewed journals.

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:

How to Apply:

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:

SKILLS AND ATTRIBUTES: EDUCATION AND EXPERIENCE: Degree in drug metabolism, biochemistry, pharmacokinetics, pharmacology or related field. PhD with 1- 5 years, or MS with 8+ years of experience in a pharmaceutical industry setting.

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

Qualifications: If you?re passionate about bringing clinical trials to life, we encourage you to apply today!

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:

Requirements: minimum of a PharmD, MD, or PhD with knowledge of PK/PD analyses. Excellent communication skills and ability to work independently as well as a member of an interdisciplinary team are essential. Interested applicants can apply through this web site: http://pharmacydpetfellowships.web.unc.edu/

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


Last update: Fri 21 Jun 2019 06:20:47 pm


Copyright © 2003-2019 David Bourne (david@boomer.org)