Scientific Director Discovery NCE DMPK (all genders)
Your role:
We are seeking an experienced Scientific Director to join our Discovery DMPK team Darmstadt Germany.
As Scientific Director you will champion and develop new scientific ideas and concepts specifically focused on DMPK-related activities. This will include scientific excellence and validation of in vitro, in vivo and in silico DMPK assays. You will provide support for external opportunity evaluations. The role coaches peers and contribute to maintaining a strategic network within and outside. You will provide scientific input to DMPK strategic goals and contribute to the overall goal of Discovery DMPK of selecting high quality molecules to advance in our pipeline. The Scientific Director will collaborate with the Development DMPK teams to ensure that the right development studies are conducted to manage risk and de-risk identified liabilities. The role will have good understanding of PK/PD models preferentially with hands-on experience in using them to support discovery projects.
You will be DMPK representative in project teams and support projects from concept generation up to selection of development candidates (and beyond when needed). As project representative, you will identify DMPK related key issues in Discovery projects and provide inputs to the design of new molecules to address these issues. The Scientific director will compile DMPK data to predict human PK, and in collaboration with other relevant disciplines (Clinical Pharmacology, Discovery Pharmacology, Safety, Formulation, etc) predict human efficacious dose.
Who you are:
- PhD in Drug Metabolism, Pharmacokinetics, Chemistry or related fields with >10 years of experience in DMPK, Clinical Pharmacology or related fields
- Have a proven record of in-depth knowledge of DMPK science and its application in drug discovery
- Good scientific visibility through a substantial track record of relevant publications
- Team player with strong communication skills in a multicultural environment
- Strong negotiation skills with an ability to influence in complex situations
- Highly flexible and creative with a strong sense of responsibility Excellent knowledge of spoken and written English.
External website https://www.merckgroup.com/en/careers/jobs/193786.html
26th Aug 201 [2963]
Summary The Director of the Preclinical Pharmacokinetics and Pharmacodynamics group will be responsible for leading a group of scientists responsible for the design, pharmacokinetic analysis, and reporting of non-clinical animal pharmacokinetic, toxicokinetic, and ADME studies. The Director will be responsible for the oversight of external pharmacokinetic studies, establish deliverables, maintain timelines, and foster open communication with and between the Project Teams, Preclinical Operations, members of the Preclinical PK/PD group, Pharmacometrics, Toxicology and Functional Heads. Responsibilities will also include reviewing and providing content and subject matter expertise relating to preclinical pharmacokinetics, toxicokinetics and ADME sections of regulatory documents to include: INDs, BLAs and other regulatory submissions and responses, as needed.
Responsibilities
- In concert with the Senior Director of Preclinical PK/PD, manage a team of PK scientists tasked with multiple programs with competing and aggressive time lines, prioritizing activities, and working independently
- Effectively manage the preclinical PK team tasked with study design, protocol development and study execution of GLP and non-GLP pharmacokinetic, toxicokinetic, and ADME (as needed) studies
- Provide input to the toxicokinetic design in animal toxicology studies
- Supervise, assist, and mentor contributing scientists on pharmacokinetic analysis, data interpretation, and report writing.
- Empower subordinates and provide for the professional development of their staff
- Functions as study director or principal investigator responsible for externally conducted PK, TK and ADME (as needed) studies as appropriate
- Interact with the Scientific Writing Team in the creation of preclinical PK/TK written and tabulated summaries for IND and BLA applications, as well as IBs, annual updates and other regulatory activities
- Interact closely with other managers and contributing scientists tasked with bioanalytical assay development, and/or sample analysis to ensure seamless and timely transfer of bioanalytical and ADA data to the Preclinical PK/PD team
- Education: PhD, in pharmacokinetics or a biological or related discipline (e.g. pharmacology, toxicology, biology. biochemistry, pharmaceutical science).
- 12+ Years of experience
- Good understanding of both theoretical pharmacokinetics theory and practical application of those principles
- Experience in contributing to pharmacokinetic summaries for regulatory documents successfully submitted to regulatory agencies.
- Advanced scientific writing skills
- Experience in animal PK/TK studies, including protocol design & study conduct
- Experience with PK software and have an understanding of non-compartment & multi-compartment modeling
- Maintains a compliant work environment by staying current with SOPs and being up-to-date with existing GLP guidelines
External website https://careers.regeneron.com/job/REGEA0026306922/Director-Preclinical-Pharmacokinetics-and-Pharmaco
Contact email address: christopher.kohl@idorsia.com - 22nd Aug 201 [2961]
About Idorsia Pharmaceuticals Ltd
Idorsia Ltd is reaching out for more - We have more ideas, we see more opportunities and we want to help more patients.
In order to achieve this, we will develop Idorsia into one of Europe’s leading biopharmaceutical company, with a strong scientific core.
Headquartered in Switzerland - a European biotech hub - Idorsia is specialized in the discovery and development of small molecules, to transform the horizon of therapeutic options. Idorsia has a broad portfolio of innovative drugs in the pipeline, an experienced team, a fully-functional research center, and a strong balance sheet – the ideal constellation to bringing R&D efforts to business success.
Idorsia was listed on the SIX Swiss Exchange (ticker symbol: IDIA) in June 2017 and has over 600 highly qualified specialists dedicated to realizing our ambitious targets. ob Responsibilities
Providing quantitative pharmacokinetic and pharmacodynamic modeling and simulation expertise to pre-clinical project and Life cycle teams Applying quantitative PK/PD modeling and simulation to inform pre-clinical candidate selection Being a champion and advocate for pharmacometrics within the company Analyzing, interpreting and reporting pharmacokinetic and pharmacodynamic data from pre-clinical studies Performing PK/PD simulations and predicting pre-clinical and clinical PK from nonclinical data as appropriate Collaborating, mentoring and guiding other DMPK team members with pharmacometric support on their projects Interacting cross-functionally with other departments including Medical Organization, Toxicology, Formulation and Discovery Preparing and/or reviewing PK, PK/PD components of internal documents, briefing books and regulatory submission documents (e.g. IND, NDA, IB) Actively preparing, reviewing and publishing scientific papers and abstracts Representing the DMPK line on project teams spanning Discovery to NDA
Candidate’s Requirements
- PhD in a relevant discipline (e.g. Quantitative Pharmacology, Pharmaceutical Sciences, Chemical Engineering)
- 2 to 3 years experience in Modelling and Simulation in the Pharmaceutical Industry or Contract Research Organisations as a minimum
- Proficient in spoken and written English
- Strong understanding of pharmacokinetic and pharmacodynamic principles including PBPK
- Good general knowledge about DMPK principles, DMPK in vitro assays, DMPK in vivo models
- Hands-on experience with modeling and simulation software packages (WinNonlin Phoenix, Monolix, R)
- Experience with Gastroplus, SimCYP would be advantageous
- Must be a team player and great communicator
- Self-driven and enthusiastic scientist
- Exciting opportunities for development and professional growth within our dynamic organization
- A collaborative and solution-oriented environment where you can make a difference
- An innovative and open culture in a truly multicultural environment
- A competitive salary and generous social benefits
Country: Switzerland
Business Area: Drug Discovery - Pharmacology DMPK
Schedule: Fulltime
Job Type: Permanent
Job ID: 1256 Please apply exclusively via the career portal on our home page.
External website https://careers.idorsia.com
Contact email address: telder@stem-sourcing.com - 2nd Aug 201 [2960]
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