URGENT CLIN PHARM M/S QSP NEED: Director level roles. Individual contributor or roles that require the management, training and mentoring of junior scientists. Progress your career in a growing environment that is on the cutting edge. Openings in small molecule, gene therapy and antibodies
Director, Clinical Pharmacology
Job Description
Company is looking for a Clinical Pharmacology leader to join the team in Boston, MA. The Clinical Pharmacology leader is a highly scientific role, supporting multiple facets of Clinical Pharmacology, including study design, PK and PK/PD analyses, and overall drug development support. He/She will complete assigned work in a resourceful, self-sufficient manner and will be able to create alternative approaches to achieve desired results if needed. The candidate will have an excellent knowledge of Clinical Pharmacology principles, such as PK, PK/PD, drug metabolism, and DDI, as well as a good understanding of related disciplines such as pharmaceutical development, regulatory, and overall drug development.
Key Responsibilities:
- Performs analysis of clinical pharmacology data (PK/PD) from phase 1-4 clinical studies with minimal supervision.
- Develops clinical pharmacology data analysis plans with minimal supervision.
- Provides peer-reviewed interpretation of clinical pharmacology data and incorporates appropriate analyses into reports required for regulatory submissions.
- Provides complex clinical pharmacology input to clinical development plans, Investigator’s Brochure and Clinical Pharmacology section of INDs, CTAs and/or NDAs with supervision.
- Leads study conceptualization, protocol development, and study start-up activities, including site initiation and investigator meetings.
- Prepares responses to inquiries from regulatory agencies with minimal supervision
- Provides scientific and technical input about clinical pharmacology-related issues within project teams, as assigned.
- Provides program development support with a higher level of oversight.
- Collaborates with colleagues in bioanalytics, biometrics, clinical development, drug metabolism and pharmacokinetics, toxicology, and regulatory affairs for clinical studies.
- Demonstrates a good understanding of the requirements of the study design, conduct, analysis and report writing for regulatory submissions.
- May have direct reports
- Ph.D. in Pharmacokinetics, Pharmaceutical Sciences, or other life sciences with 8+ year’s experience in the Biotechnology/ Pharmaceutical Industry or post-doctoral training.
External website https://www.stem-sourcing.com
2nd Aug 201 [2959]
Pharmacometrician - Brisbane, Australia
The Position
Model Answers R&D Pty Ltd is seeking applications for a pharmacometrician to join their team in Brisbane, Australia. The successful applicant will work in an inspiring group that provides a range of quantitative solutions to a global client network. The position would suite a highly motivated individual with a desire to continuously learn, and looking for a challenging opportunity to facilitate successful drug development. Applicants should have excellent time management and communication skills with a background in pharmacokinetic / pharmacodynamic data analysis. Applicants should also have programming experience in SAS, R or SPlus, and demonstrated modelling experience using NONMEM or equivalent software.
Essential Skills:
- Qualification in Pharmacokinetics or Pharmaceutical Sciences
- Experience using statistical modelling approaches to analyze PK/PD, PK, and population PK data
- Use of modelling and reporting software such as NONMEM, MATLAB, SAS, R, among others
- Technically orientated and very computer literate
- Excellent attention and accuracy with details
- Working closely with the team to ensure a seamless operation across all aspects of the business
- Ensuring Model Answers processes are followed and developed, including, but not limited to, any matters relating to QA, QC, HR, Science, Audit
- Project tracking and task management, working with the Model Answers Team
- Ongoing learning and development
- Contributing toward the cultural goals of Model Answers and sharing with team members
All positions are located in the central business district of Brisbane. Model Answers R and D Pty Ltd is a growing consultancy business dedicated to helping pharmaceutical and biotech companies make successful drug development decisions. Employees, shareholders and equity stake holders are expected to be upstanding members of the community, who have an inbuilt desire to develop, create, and innovate. Opinions and ideas are welcomed, resulting in a dynamic business, led by those who work in the business.
Interested applicants should apply via recruitment@model-a.com.au or refer to our website (www.model-a.com.au) for further information. Applications close 26 August 2019.
External website https://www.model-a.com.au
Contact email address: pvandervalk@rosaandco.com - 18th Jul 201 [2950]
Rosa and Co. LLC is expanding and seeking a Biological Systems Modeler, an Associate Life Scientist, as well as a Senior Life Scientist, to join our PhysioPD consulting practice.
Rosa is a drug-disease modeling and simulation company created to provide innovative modeling solutions to its biopharmaceutical clients and meaningful equity ownership to its employees.
Life Scientists and Modeling Engineers work together in our PhysioPD practice to develop physiologically-based, dynamic mathematical models and conduct simulations of disease, drug action, and (pre)clinical studies.
Full and part-time employment and project-based contracting opportunities are available throughout the United States.
Rosa is an equal opportunity employer. Upon hiring, proof of eligibility to work in the United States will be required.
For more information, visit https://www.rosaandco.com/news
External website https://www.rosaandco.com/news
Contact email address: telder@stem-sourcing.com - 17th Jul 201 [2949]
Senior Scientist or Associate Director Clinical Pharmacology
Key Responsibilities
Independently represent DMPK, Clinical Pharmacology as a core member of clinical trial working groups (CTWG): Contributing to clinical trial designs Authoring clinical study protocols Executing and coordinating clinical trial conduct Finalizing clinical study reports All of this to be performed within agreed timelines and meeting all regulatory requirements.
Align plans with sub-teams, study teams, manager and DMPK senior staff. Manage CROs for clinical pharmacology related studies and activities: Developing study timelines, objectives and budgets Ensuring accuracy of project progress and completion Pro-actively identifying hurdles and providing solutions. Analyze and interpret PK/PD data generated during conduct of the clinical trials Communicating results and impact of results in a timely and effective manner to clinical study teams and development sub-teams.
Participate in and eventually lead internal DMPK sub-teams to define DMPK strategy for compound development. Actively participate in cross-departmental teams, department-wide initiatives and work streams. Present and publish internally and externally as main contributor to enhance visibility of DMPK, Clinical Pharmacology department. Complete all required organizational trainings and requirements according to corporate timelines and adhere to the appropriate SOP and GxP guidelines.
Minimum Requirements
Education: PhD or PhD accompanied with post-doctoral training in clinical pharmacology, pharmaceutical sciences or related areas such as pharmacokinetics, pharmacology or drug metabolism. Experience in conducting clinical pharmacology studies including study design, PKPD data analysis and/or population PK analysis, and result interpretation is required. A working knowledge and previous experience, either in the industry or as part of the educational training, with pharmacokinetic/pharmacodynamics, drug metabolism, drug-drug interactions, and population PKPD modeling is required. Must excel at working in a highly collaborative matrix team environment, have good organizational, communication [both oral and written], and interpersonal skills. Must be able to work independently. Preferred Qualifications
2-6 years of industry experience working as a clinical pharmacologist. Level is flexible, exact level and responsibilities will depend on the individual’s experience and interpersonal skills.
Working experience with DMPK- bioanalysis, data management and statistical programming groups is preferred. Prior experience working with CROs is preferred. Broad familiarity with the drug development process, preferably in oncology and rare disease areas is highly desired. Preferably 3 years of relevant experience in drug development. Advanced training in WinNonlin, R, SAS, NONMEM and/or Monolix would be a plus.External website https://www.stem-sourcing.com
Contact email address: kamirault@deciphera.com - 17th Jul 201 [2948]
In this newly created role, you will have the opportunity to independently lead the clinical pharmacology strategy for DCC–3014, a clinical stage selective inhibitor of CSF1R, and play a key role in the upcoming regulatory meetings.
In this highly visible role, you will present clinical pharmacology plans, updates, and results to project teams and senior management. This is an exciting opportunity to provide leadership to the clinical pharmacology function, provide support to the Director and mentor junior team members.
This position will report to the Director of Clinical Pharmacology.
Key Responsibilities:
- Act as the lead clinical pharmacologist for one or more oncology programs
- Independently formulate clinical pharmacology strategy to support regulatory submissions (e.g. NDA, MAA)
- Work in close partnership with Medical, Regulatory, Clinical Operations, Biostatistics and Translational Medicine to advance these programs from Phase I to late-stage development
- Responsible for designing and implementing dose finding strategies to ensure optimal dose and dosing regimens in clinical trials
- Draft clinical pharmacology components of protocols, investigator's brochure and other regulatory documents
- Oversee the design and protocol writing of clinical pharmacology studies (e.g. food effect, human ADME, drug interactions, QTc, renal and hepatic impairment)
- Manage external vendors to perform PK and PK/PD analysis and integrate this knowledge into the overall clinical program
- Provide ad-hoc support to other programs as needed
- Ph.D., Pharm.D. or equivalent training in pharmacokinetics, pharmaceutical sciences or related disciplines
- Ph.D./PharmD with 3+ years’ experience in Clinical Pharmacology
- Strong understanding of clinical pharmacokinetic concepts
- Regulatory filing experience
- Strong technical proficiency in PK analysis (NCA and PopPK)
- Working knowledge of DMPK and Toxicology
External website https://www.deciphera.com/careers/career-opportunities/
Contact email address: kerry@kobsolutions.com - 1st Jul 201 [2947]
Biotech Translational Scientist
DC Area
My client is expanding and looking to hire a Scientist for their development group. This is a high impact role - the ideal candidate will take on the following tasks:
- Act as primary point of contact for PK/PD-related activities on preclinical and early clinical development programs
- Manage analyses of PK/PD data, integrating preclinical study simulation strategies and informing of the relevant risk and benefit implications
- Liaise with the preclinical and bioanalytical sciences team and regulatory in creating preclinical PK/TK written and tabulated summaries for IND and BLA applications
- Collaborate within the development on the design and reporting of nonclinical safety studies and comply with GLP regulations for GLP studies
- Perform PD, biodistribution and immunogenicity analyses for GLP studies, record data and analysis results in GLP-compliant manner, and ensure timely and clear communication with other groups
- PhD in pharmacology, toxicology, biology, etc plus 3+ years of biotech industry experience.
- Previous contributions to PK summaries for regulatory documents
- Ability to maintain a compliant work environment by staying current with SOPs and being up-to-date with existing GLP guidelines
- Expertise with pharmacodynamics, biodistribution and immunogenicity assays
- Expertise with PK software and modeling
- Experience in animal PK/TK studies, including protocol design & study conduct
- Experience in formulating hypothesis testing for early clinical studies, using in vitro and in vivo preclinical studies and patient samples.
Please contact Kerry Boehner at KOB Solutions at kerry@kobsolutions.com if you have any questions or would like to pursue.
thank you!
External website https://bit.ly/2XbTZln
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
- experience in the areas of pharmacokinetics and pharmacodynamics, and applications of biostatistics to these areas
- experience in using nonlinear mixed effects modeling (e.g., NONMEM, Phoenix NLME) and R. Able to work with minimal supervision on assigned modeling projects.
- experience with PBPK modeling software desirable (e.g., Gastro Plus, Symcyp Simulator)
- Publications in well-respected journals and records of high productivity.
- Preference will be given to those who have excellent communication skills and ability to work independently as well as a member of an interdisciplinary team are essential.
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:
- Leads the initiation and execution of Drug Metabolism and Pharmacokinetic (DMPK) aspects of drug projects at the company’s healthcare portfolio across all therapeutic modalities and indications.
- Manages a world leading DMPK department globally. Ensure internal and external resources are fully engaged and developed.
- Manages key external relations for the larger Discovery Technologies team and the company.
- Creates the vision for DMPK and designs the long-term global strategy and operational model for the company’s healthcare research worldwide.
- Ultimate decision-making for all issues associated with pharmacokinetic aspects of drug projects.
- Creates a culture of innovation, entrepreneurship and global, collaborative working
- Assigns resources and budget to all projects on a global basis. Ensures departmental performance in terms of quality clinical candidate delivery.
- Accountable for cutting-edge infra-structure including laboratories, automation and robotics, design tools, electronic lab note-books and collaborative IT tools.
- Initiates and leads external collaborations with major external scientific collaborators. Creates a climate of externalization and external innovation.
- Resolves highly complex business and scientific problems through excellent scientific judgment and broad research, development and commercial knowledge.
- Chairs the global DMPK leadership team. Member of the the company Healthcare’s Discovery Research Committee and the Discovery and Development Technologies leadership team.
- Generation the value of the company Healthcare’s clinical pipeline through quality candidate delivery.
- Allocation of resources, setting strategies, priorities and policies, disseminating best practice and planning of the global DMPK Function.
- Contribution to all in-licensing activities, including clinical-stage assets.
- Involvement to the strategy of drug discovery at the company. Predicts and preempts the company’s pipeline needs in all therapeutic areas.
- Creation synergies and collaborates across the company’s functions beyond biopharma, e.g., Life Science division.
- Ph.D. and/or Post-Doc in drug metabolism, pharmacokinetics, analytical chemistry, synthetic organic chemistry, medicinal chemistry, protein engineering or immunology.
- 10+ years in industry, at least 5 of which in managerial roles in R&D.
- Ideally, experience in both small molecule and therapeutic proteins.
- Demonstrated leadership experience in global organizations.
- Strong track record of clinical candidate delivery and publications.
- Experience in designing high performance DMPK organizations.
- Experience in working with external partners.
- Cross-divisional knowledge and awareness.
- Ability to travel internationally up 20% of the time.
- Fluency in English.
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:
- Represent Clin Pharm and M&S on project teams
- Develop pop PK strategies for new and developing compounds
- Participate in the submission of regulatory documents
- Work directly with regulatory agencies on clin pharm projects in development
- PhD/Pharm D or realted degree in PK or pharma sciences
- 3+ years’ experience in industry
- Solid knowledge of DMPK, PK/PD
- Strong background and hands-on experience interpreting clinical dose-response and PKPD data.
- Proficiency with WinNonlin, NONMEM, R, MATLAB, or other modeling software
- Excellent oral and written communication skills and a proven track record of working effectively in a dynamic, collaborative, team-oriented setting
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
- experience in the areas of pharmacokinetics and pharmacodynamics, and applications of biostatistics to these areas
- experience in using nonlinear mixed effect modeling (e.g. NONMEM, Phoenix NLME) and R. Able to work with minimal supervision on assigned modeling projects.
- experience with PBPK modeling software desirable (Gastro Plus, Symcyp Simulator)
- Publications in well-respected journals and records of high productivity.
- Preference will be given to those who have excellent communication skills and ability to work independently as well as a member of an interdisciplinary team are essential.
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:
- Prepare clinical pharmacology development strategies for multiple small molecule compounds.
- Design clinical pharmacology studies that yield high value PK/PD insight. Analyze PK/PD data and interpret results to maximally impact program goals.
- Drive translational approaches via the clinical development plan from phase 0 to IV.
- Work closely with Research and Clinical Development to fully leverage and integrate the understanding of a compound and its biology.
- Provide expertise and knowledge of translational aspects, including clinical biomarkers and modeling and simulation efforts.
- Develop scientific rationale and concepts for personalized/stratified medicine to optimize patient outcomes.
- Apply strong knowledge of best regulatory practices, technology and development precedent.
- Support regulatory strategy and is responsible for clinical pharmacology sections of regulatory documents.
Skills:
- Has extensive knowledge and practical understanding of current clinical pharmacology within the realm of translational medicine and general drug development.
- Understands and is able to apply appropriate regulatory and ICH guidelines in the design and execution of clinical pharmacology and clinical development plans.
- Experience with immunology drug development is highly desirable.
- Possess strong leadership and excellent communication skills. An ability to manage, mentor and develop direct reports would be an asset.
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:
- 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