The Center for Pharmacometrics and Systems Pharmacology (CPSP) in the Department of Pharmaceutics (PC) at the University of Florida College of Pharmacy (COP) on the Lake Nona (Orlando) campus invites applications for a Postdoctoral Research Fellow position. The successful applicant will have demonstrated expertise in Computer Science, preferably in the area of biosciences and will join the CPSP to develop state-of-the art integrative multidisciplinary models. Demonstrated experience in machine learning and/or other artificial intelligence tools will be considered as an advantage. The candidate will be working under the joined supervision of Dr. Stephan Schmidt and Dr. Valva Vozmediano.
Minimum requirement: The successful applicant will hold a Ph.D. with training in applied Computer Science. FDLE Criminal Background Check Required.
Preferred Qualifications: The successful applicant will have experience in the area of machine learning or other artificial intelligence tools. Soft skills are essential to team-based research, and in order to provide clear verbal and written communication between, trainees, faculty, and external collaborators. Industry experience is an added attribute for the successful candidate provided that a thorough understanding of drug development and regulatory decision making process is helpful for successfully working in the highly collaborative environment of the Center and its partners.
External website https://careers.insidehighered.com/job/2132725/post-doctoral-associate-73163-/
Contact email address: telder@stem-sourcing.com - 5th May 202 [3052]
Senior Scientist or Associate Director DMPK/Clinical Pharmacology
Our Client is searching for a/n Senior Scientist/Associate Director primarily responsible for providing DMPK and clinical pharmacology expertise. The successful candidate will have expertise in clinical pharmacology and pharmacokinetics with experience managing studies contracted to CRO’s and applying this knowledge to the advancement and selection of drug candidates.
Responsibilities:
- Provide expert PK, and clinical pharmacology to support compound advancement and evaluation
- Clinical Pharmacology: Conducts the analysis, interpretation and reporting of clinical and non-clinical pharmacokinetic data. Helps plan, conducts and reports quantitative analyses to select / optimize doses, dosage regimens throughout clinical drug development
- Regulatory: Manage the preparation and/or presentation of nonclinical pharmacology sections of external documents (e.g. Investigator’s Brochure, IND/ CTA,NDA.)Pharmacometrics: Performs exposure-response and PBPK modeling using a variety of software,
- CRO oversight: delivers critical project data through a network of external study providers. In collaboration with project teams, participate in study design, troubleshooting, data analysis and interpretation, Reviews study reports,
- DMPK: Utilize animal models, define efficacy, pharmacodynamics and translational principles for selection of development candidate molecules
- Translational and Biomarker studies: Facilitate project transitions to Clinical Development in close collaboration with discovery, translational and clinical scientists
- Flexibility: Must be able to contribute to a portfolio of projects spanning early and late preclinical discovery, translational medicine, and clinical development
- Communication: Play a key role in representing data, interpretations and nonclinical plans for molecules in our pipeline to external parties
- Ph.D. in Pharmacology, Biomedical Sciences, Pharmacokinetics or other discipline with appropriate experience
- Strong technical proficiency in PK analysis (NCA)) Experience with PBPK modeling. DDI simulations is a plus.
- Demonstrated small molecule drug discovery experience: track-record of advancing multiple novel therapeutic agents from discovery into clinical development as project team leader or member
- Experience in successfully managing CROs to provide high quality and timely studies
- Strong written and verbal communication skills - ability to clearly and persuasively articulate complex concepts and strategies to a diverse audience
External website https://www.stem-sourcing.com
Contact email address: telder@stem-sourcing.com - 27th Apr 202 [3051]
Sr. Dir. Clinical Pharmacology and Pharmacometrics*****West Coast****
Our Client is seeking an experienced clinical pharmacology leader to work on an aggressive pipeline with over 10 programs in the pipeline many in Phase 1 and Phase 2.
Strong partnerships with large pharma are propelling this company into an exponential growth mode.
Qualifications
Pharmaceutical industrial experiences in the related disciplines of clinical pharmacology, PKPD M&S, and QSP;
Excellent hands-on knowledge in R, S-PLUS and/or SAS, NONMEM;
Excellent knowledge in Matlab, or other QSP related softwares or computing platform;
Well versed at plotting complex data to identify trends important for drug development;
Proven track record of applying quantitative system pharmacology methodologies in a drug R&D context;
Proven track record of contributions to INDs, NDAs/BLAs, and various regulatory submissions;
Excellent track record of publishing M&S work, and a recognized expert in PKPD M&S and PMX field.
External website https://www.stem-sourcing.com
Contact email address: valva@cop.ufl.edu - 26th Apr 202 [3050]
The Center for Pharmacometrics and Systems Pharmacology (CPSP) in the Department of Pharmaceutics (PC) at the University of Florida College of Pharmacy (COP) on the Lake Nona (Orlando) campus invites applications for a Postdoctoral Research Fellow position. The successful applicant will have demonstrated expertise in Computer Science, preferably in the area of biosciences and will join the CPSP to develop state-of-the art integrative multidisciplinary models. Demonstrated experience in machine learning and/or other artificial intelligence tools will be considered as an advantage. The candidate will be working under the joined supervision of Dr. Stephan Schmidt and Dr. Valva Vozmediano.
Minimum requirement: The successful applicant will hold a Ph.D. with training in applied Computer Science. FDLE Criminal Background Check Required.
Preferred Qualifications: The successful applicant will have experience in the area of machine learning or other artificial intelligence tools. Soft skills are essential to team-based research, and in order to provide clear verbal and written communication between, trainees, faculty, and external collaborators. Industry experience is an added attribute for the successful candidate provided that a thorough understanding of drug development and regulatory decision making process is helpful for successfully working in the highly collaborative environment of the Center and its partners.
External website https://careers.insidehighered.com/job/2132725/post-doctoral-associate-73163-/
Contact email address: junjie.ding@astrazeneca.com - 16th Apr 202 [3048]
Clinical Pharmacology (CP) team in AstraZeneca R&D China is looking for several highly motivated clinical pharmacologists from principal scientist to associate director level. CP team is responsible for all aspects of clinical pharmacology-related support for small molecules and biopharmaceutical products at various stages of clinical development.
This position serving as a senior member of the CP team to provide strategic and scientific CP support for clinical development programs in multiple therapeutic areas (TA), interacting with regional and global project teams as well as senior management.
If you are interested in this position, please email your resume to Junjie Ding (junjie.ding@astrazeneca.com) and Daphel Li (daphel.li@astrazeneca.com)
DUTIES & RESPONSIBILITES
Provide CP expertise and leadership in clinical development programs, including:
- Design and conduct clinical studies including CP studies (dosing rationales, sampling schemes, etc.)
- Data analyses (e.g., M&S) to elucidate dose-exposure-response relationships, and result interpretations
- Preparation and defence of regulatory submissions
- Compile and contribute to sections of drug development and registration documents such as clinical trial protocols and reports, drug package inserts and regulatory submission packages, etc.
- Interact with internal and external stake holders for assigned projects:
- Serve as a China liaison with Global CP
- Serves as core member of the China Project Team
- Interact with investigators for scientific issues
- Responsible for delivering quantitative pharmacology and M&S supports to clinical development projects:
- Play a central role in predicting human dose range, characterizing dose-exposure-response relationship, justifying dose recommendations for special populations, and evaluating ethnic sensitivity
- Develop mathematical and statistical models to understand disease mechanism, its progression, and PK/PD; conduct meta-analyses as appropriate to maximize data use
- Train junior CP staff
- Support establishing best practices for CP activities (e.g., M&S)
- Evaluate in-licensing opportunities for clinical PK and PK/PD components when needed
- Literature research and knowledge sharing
- Ph.D/PharmD/MD in relevant disciplines (CP, pharmacokinetics (PK), pharmacometrics) or other equivalent degrees or knowledge/expertise
- 3+ years of relevant industry experience in CP and Modeling & Simulation (M&S) role
- Early and late phase clinical development experience
- Proven track records and skills in PK, Pharmacodynamics (PD) and longitudinal disease modelling; and proficiency in pharmacometric tools (e.g., NONMEM, R, Monolix, etc.)
- Adequate understanding of related disciplines (e.g., DMPK, toxicology, biostatistics, medical, regulatory) in drug development
- Excellent communication and negotiating skills
- Ability to function effectively in a highly cross-functional team and dynamic environment
- Fluent in English (oral and written)
- Team working spirit with self-motivation
6th Apr 202 [3047]
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 39,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.For more than a century, Eli Lilly and Company has been committed to making life better. At Lilly, we continuously focus on new and innovative ways to fulfill our extraordinary purpose of making medicines that help people live longer, healthier, more active lives. Our goal is to add to our diverse team of scientists a teammate passionate about improving the lives of people around the globe. Passion, curiosity, creativity, and persistence are qualities of our research area. We strive to affect change and deliver results. Do you have the scientific and technical expertise to influence and apply model-informed drug discovery and development? Confident and compelling communication will be key in this role.
The Global Pharmacokinetics/Pharmacodynamics and Pharmacometrics Department at Lilly is looking for creative, motivated and hardworking scientists to join our group. The scientists in our group are functional leaders in research and development throughout the value chain from preclinical lead molecule identification to clinical post-drug approval. Optimally identifying and developing the right drug with the right dose for the right patient and living the model-informed drug research and development (MIDD) paradigm is the goal.
Our organization seeks a multifaceted, experienced, and driven scientist who is able to:
- Provide PK/PD/Pharmacometric and scientific leadership to project teams to support the selection of the right target, molecule, dose, patient population, and development strategies; apply the appropriate PK/PD and pharmacometric approaches to translate from preclinical to the clinical setting by integrating data from multiple fields.
- Expect and understand the high-level issues affecting the drug discovery/development process and help derive at effective solutions. Support decision-making through collaboration on cross-functional teams.
- Develop PK/PD sections of program and product team plans/strategies as project leader.
- Lead and support the preparation and delivery of Phase I, II, and III study protocols, analysis plans, data analysis and interpretation, and study reports.
- Responsible for preparation of relevant INDs, IBs, CTDs and other regulatory documents for development and registration of new drugs and line extensions across multiple geographies. This may involve direct interaction with FDA, EMA, PMDA and other regulatory agencies.
- Mentor other scientists within the department and in other areas as well as interact, teach and collaborate with academia.
- Represent the group to increase visibility externally, through key publications, active leadership in key scientific organizations, industry trade groups, or consortia
Basic Qualifications:
- PhD and/or MD in relevant scientific area such as biological/pharmaceutical sciences, bioengineering or related field.
- At least 5 years of experience from industry, regulatory, consulting or academia with exposure to industry.
- Excellent understanding of clinical pharmacology (PK, PD and pharmacometrics) principles.
Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
To submit resume, visit https://www.lilly.com/careers and apply to Req ID R-11720.
Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
External website https://careers.lilly.com/job/indianapolis/principle-research-scientist-pk-pd-and-pharmacometrics/41
Contact email address: telder@stem-sourcing.com - 29th Mar 202 [3046]
DMPK Scientist
Our Client is seeking a highly motivated and team-oriented candidate for the position of Scientist in the Drug Metabolism and Pharmacokinetics (DMPK) Department. The successful applicant will lead the development, validation, and application of cell based in vitro ADME assays to support our discovery and development programs. Reporting directly to the Senior Director of Clin Pharm, this is a unique opportunity to take on a role with a broad range of responsibilities and work in DMPK and Clinical Pharmacology.
Core responsibilities:
Utilize animal models, define efficacy, pharmacodynamics and translational principles for selection of development candidate molecules
Conducts the analysis, interpretation and reporting of clinical and non-clinical pharmacokinetic data. Helps plan, conducts and reports quantitative analyses to select / optimize doses, dosage regimens throughout clinical drug development
Experience with Simcyp, Monolix, Phoenix Winnonlin or other modeling software. PBPK experience and experience with DDI
Qualifications:
Must have 2+ years of experience in the pharma/ biotechnology industry or Post Doc.
Ph.D./PharmD in Pharmacology, Biomedical Sciences, Pharmacokinetics or other discipline with appropriate experience
Strong, demonstrable track record of scientific leadership excellence
Demonstrated small molecule drug discovery experience: track-record of advancing multiple novel therapeutic agents from discovery into preclinical and subsequent clinical development as project team leader or member
Experience in successfully selecting and managing CROs to provide high quality, timely and on-budget studies
External website https://www.stem-sourcing.com
Contact email address: broseberry@cartermackay.com - 25th Feb 202 [3045]
Please see below role and let me know if interested or have a referral. Position is with an established pharma client. Full time, salary, benefits. Location is MA but can also be remote/WFH with some minimal travel to meet with direct reports from time to time post covid shutdowns.
Senior Director, Head of Pharmacometrics
Position Summary
The Head of Pharmacometrics will be reporting to the Senior Vice President of Clinical Pharmacology and Pharmacometrics. In this position, the head of pharmacometrics is expected to provide strong technical and strategic leadership to a group of talented pharmacometricians and, strengthen and champion quantitative model based drug development across the organization. Will be responsible for pharmacometrics plan, conduct and review of modeling analysis for internal decision making and regulatory filings. Candidate should possess scientific curiosity and a passion for quantitative science based interrogation of data.
Major Duties and Responsibilities
- Strategize, formulate and execute on modeling and simulation strategy for clinical projects with ability to independently plan, design, analyze, interpret and report PKPD modeling results for internal decision making and regulatory filings
- Train, mentor and grow pharmacometrics team members in modeling and simulation skills.
- Responsible for identification of dosing regimen and optimization of dosing for products
- Collaborate and influence decision making pertaining to dosing and clinical trial design on project teams
- Strategize, collaborate cross-functionally with other departments and provide modeling and simulation support
- Formulate pharmacometric strategy and responses to regulatory health authority inquiries on PK, PK/PD, dosing and clinical pharmacology related issues. Represent pharmacometrics at regulatory meetings.
- Enhance role and visibility of pharmacometrics internally within the company and showcase expertise through publications in peer reviewed journals and presentations at scientific meetings
- Candidate with a Ph.D (or equivalent) degree in pharmacokinetics, biopharmaceutics or related field
- At least 10 years of pharmacometrics experience in pharmaceutical industry or regulatory agency. Should have hands-on experience and an expert in NONMEM, S-plus, R-, SAS and WinNonlin and should be intimately familiar with the drug development process. Be a team player and a strong cross-functional contributor and partner.
- Candidate should possess good understanding of pharmacokinetic and pharmacodynamic principles and have extensive experience in quantitative population PK/PD modeling and simulation using NONMEM
- Candidate should have experience in clinical endpoint, disease progression and mechanistic modeling
- Strong managerial skills with proven record of mentoring and advancing a pharmacometric group
- Candidate should have experience writing clinical pharmacology sections of NDA/MAA and preparation of pharmacometric reports to support regulatory filings
- Strong written and oral communication skills
- Team player with strong interpersonal skills
- Ability to strategize, influence, advance and implement model based drug development. Formulate strategy and engage with regulatory authorities on development proposals particularly around dose selection. Showcase value of modeling and simulation through informed decision making.
- Independent contributor who is able to multi-task and prioritize with minimal supervision. Provide mentoring, strategic and planning support and train pharmacometrics team members in advanced pharmacometric skills. Motivated to promote role of pharmacometrics across the company in a personable, result-oriented and collaborative manner.
Contact email address: telder@stem-sourcing.com - 24th Feb 202 [3044]
DMPK Scientist
Position & Responsibilities: Our Client is seeking a DMPK Scientist experienced in structural elucidation of oligonucleotides and small molecules by applying analytical techniques including mass spectrometry. S/He will be joining a team of highly motivated and experienced chemists and biologists and contribute to the success of the organization. S/He will be expected to:
- Design and execute metabolite profiling and identification from in vitro and in vivo samples of various matrices
- Interpretation of metabolic profiles and structural elucidation based on established biotransformation pathways
- Develop and execute other IND-enabling in vitro ADME assays (e.g., metabolic stability, plasma protein binding, gel electrophoresis)
- Support LC-MS instruments daily operation, maintenance, and trouble shooting
- Presentation of detailed results to project teams
Required:
- PhD (or work experience equivalent) in Biochemistry, Pharmaceutical Science, or a related discipline with > 3 years of industry experience
- Experience with sample preparation and extraction methods.
- Deep expertise in metabolite profiling and identification, including HRMS instrumentation and technologies
- Knowledge of nucleotide drug detection, quantitation and biotransformation desired
- Direct hands-on experience and strong trouble shooting skills with in vitro assays, in vivo studies, and various LC-MS platforms
- A strong track record of accomplishments with excellent interpersonal, verbal and written communication skills
External website https://www.stem-sourcing.com
Contact email address: broseberry@cartermackay.com - 17th Feb 202 [3043]
Associate Director Clinical Pharmacology, NJ
please contract me at broseberry@cartermackay.com for more info.
New Associate Director role available with pharma client in NJ. Please email me at broseberry@cartermackay.com for more info
The Associate Director, Clinical Pharmacology position will support the clinical pharmacology programs for an expanding portfolio of products across several disease areas. This role will independently execute routine clinical pharmacology tasks with minimum supervision and may include oversight of vendors and/or contractors.
Responsibilities:
- Represent Clinical Pharmacology and provide PKPD support.
- Lead the analysis, interpretation, integration and reporting of clinical pharmacokinetic & pharmacodynamic data
- Conduct PK/PD analyses to guide development decisions on project teams
- Provide PKPD input for regulatory submissions such as briefing documents, IND, CTA and NDA
- Prepare appropriate documents or sections of clinical protocols, Investigator Brochures, Clinical Study Reports with respect to Clinical Pharmacology studies or data
- Preparation of abstracts and manuscripts for publication
- Closely partner with Research, Clinical functions, Regulatory, Project Management, and other R&D functions.
- PhD in Pharmacokinetics,
- Pharmacology, Pharmaceutics or another relevant field or M.D. or PharmD with equivalent experience
- Minimum of 5 years of experience in the pharmaceutical industry
- Solid working knowledge of pharmacokinetics and modeling, PKPD principles, ADME concepts, and clinical pharmacology
- Working knowledge of pharmacokinetic, modeling and data visualizations software
- Strong communication skills (verbal and written) and presentation skills are required
- Excellent interpersonal skills and the ability to function in a highly matrixed team environment are essential
2nd Feb 202 [3042]
Organization Overview:
At Lilly, we serve an extraordinary purpose. We make a difference for people around the global by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.
For more than a century, Eli Lilly and Company has been committed to making life better for our patients and communities. At Lilly, we continuously focus on new and innovative ways to fulfill our extraordinary purpose. Our goal is to add to our diverse team of scientists a teammate passionate about improving the lives of people around the globe. Passion, curiosity, creativity, and persistence are qualities of our research teams. We strive to affect change and deliver results. Do you have the scientific and technical expertise to influence and apply model-informed drug discovery and development? We need you on our team!
Responsibilities:
This is an exciting role responsible for applying quantitative models to the discovery and development of therapeutic drug candidates. We are seeking a modeling and simulation scientist to contribute in a collaborative environment as we use diverse analytical and computational tools to characterize factors influencing the pharmacokinetic and pharmacodynamic properties of a diverse range of therapeutic modalities.
You will have the opportunity to:
- Function as a project leader in a multidisciplinary team environment
- Integrate pharmacokinetics and PK/PD with discovery biology to define structure activity relationships guiding engineering strategies and optimization of therapeutics
- Design, conduct, analyze and interpret PK/PD studies
- Communicate scientific data, both internally and in the scientific community
- Ph.D. in Pharmacokinetics/Pharmacodynamics or a related field
- Experience in PK/PD or PBPK modeling preferred
- Understanding of how to apply mathematical models to drug discovery/development
- Experience using relevant software such as WinNonlin, NONMEM, R, SimCYP or MATLAB
- Industry (pharma, biotech, CRO, etc.) experience with PK/PD or PBPK modeling
- Understanding of bioanalytical and in vitro assays used in drug development
- Prior experience working in an interdisciplinary team.
External website https://careers.lilly.com/job/indianapolis/research-scientist-modeling-and-simulation/410/18580266
27th Jan 202 [3041]
Postdoctoral Fellowship in Pharmacokinetics/Pharmacodynamics
UNC Eshelman School of Pharmacy The University of North Carolina at Chapel Hill
A postdoctoral research associate position is available to work on projects focused on characterizing pharmacokinetics/pharmacodynamics in the pediatric population. The project will involve the use of physiologically-based pharmacokinetic (PBPK) and population pharmacokinetic (PopPK) modeling techniques to characterize the effects of age, obesity, and drug-drug interactions in pediatric patients. Requirements: minimum of a PharmD, MD, or PhD with knowledge of pharmacokinetic/pharmacodynamic analyses. Demonstrated software proficiency (e.g., PK-Sim®, NONMEM®, R) is preferred. Excellent communication skills and the ability to work independently and as a member of an interdisciplinary team are essential.
Interested applicants should submit a letter describing personal goals related to the position, Curriculum Vitae, and three professional references at https://unc.peopleadmin.com/postings/187422.
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.
External website https://unc.peopleadmin.com/postings/187422
Contact email address: telder@stem-sourcing.com - 22nd Jan 202 [3040]
Sr. Scientist DMPK-Must Relocate
Responsibilities
Develop in vitro and preclinical development DMPK strategies
Manage DMPK function including both in-house resources and CROs
Design, supervise and execute preclinical PK studies
Provide discovery project teams with PK/PD expertise
Oversee preclinical PK data analysis, interpretation, and reporting
Develop IND enabling preclinical DMPK plans to meet regulatory expectations
Execution of non-compartmental analysis using Phoenix WinNonlin software
Assist in toxicokinetic study design, data analysis, and reporting
Requirements:
PhD in Pharmacokinetics, Drug Metabolism, Pharmaceutical Science, or related discipline with at least 5 years of industry experience
Deep expertise in all areas of DMPK
Direct hands-on experience and strong trouble shooting skills with in vitro assays, in vivo studies, and Phoenix WinNonlin software
Extensive experience with drug development and knowledge of regulatory processes
Experienced with FDA regulatory guidance and communications
A strong track record of accomplishments
Excellent interpersonal, verbal and written communication skills
Preferred:
Knowledge of nucleotide drugs
External website https://www.stem-sourcing.com
Contact email address: Gaohua.Lu@bms.com - 18th Jan 202 [3039]
Job Description
The Quantitative Clinical Pharmacology (QCP) group within Clinical Pharmacology & Pharmacometrics (CP&P) at Bristol Myers Squibb is searching for a scientist with expertise in Physiologically-Based Pharmacokinetics (PBPK). This scientist will develop and apply PBPK models to address drug-discovery and development questions for small molecules and biologics, in multiple therapeutic areas.
Position Requirements
Ph.D. in Pharmaceutics, Clinical Pharmacology, Toxicology, Biomedical/Chemical Engineering, DMPK or a related field with 5+ years of experience in applying PBPK modeling for DDI and PK predictions. Experience within the pharmaceutical industry or pharmaceutical consulting would be desirable. Candidates with M.S. degree and significantly more industry experience will also be considered. If less than 5 years experience and a Ph.D., you will still be considered but level of position will be commensurate with experience and capabilities.
Excellent understanding of the theory and principles in pharmacokinetics and pharmacodynamics, drug metabolism and transporters
Ability to learn new areas of biological sciences and build on solid foundation of quantitative skills to develop PBPK models
Ability to communicate internally and externally on topics related to Clinical Pharmacology and PBPK is required
Ability to keep up-to-date with and propose the implementation of scientific and technological developments in the area of PBPK
Hands-on experience with one or more of the modeling software like Simcyp, GastroPlus, PKSim, etc.
Experience with general programming and data analysis tools/languages such as R, Matlab, Berkeley Modonna, ADAPT, etc., is desirable
Interdisciplinary knowledge of current practices and issues in pharmaceutical R&D in disciplines such as DMPK, clinical pharmacology, bioanalytical, biopharmaceutics, and toxicology is desirable
Desire to interact as a modeling and simulation expert with matrix project teams working closely with experts from different functional areas (pre-clinical and clinical)
External website https://careers.bms.com/jobs/R1530007?lang=en-us
14th Jan 202 [3038]
Health Scientist Administrator (Program Officer) Office of Regulatory Affairs Division of Microbiology and Infectious Diseases National Institutes of Health Department of Health and Human Services
The National Institute of Allergy and Infectious Diseases (NIAID), one of the largest Institutes of the National Institutes of Health (NIH), is seeking exceptional applicants with diverse skill sets in pharmacokinetics and pharmacodynamics to serve as a program officer in the Division of Microbiology and Infectious Diseases (DMID). DMID supports extramural research to control and prevent diseases caused by virtually all human infectious agents (except HIV) and directs a program of research grants and contracts in microbiology and infectious diseases.
As a program officer, you will manage or contribute to clinical protocol design, gap analysis for investigational new drug (IND) filing, oversight of bioanalytical method development and validation, evaluation of preliminary pharmacokinetic data, and simulation and modeling of early data in support of follow-up studies. The candidate will serve in the Office of Regulatory Affairs to provide support to ensure the safety and efficacy of target product candidates (vaccines and therapeutics). This position is integral in providing support for strategic development plans for planned clinical trials. These clinical trials involve collaboration across all program branches of DMID, including but not limited to Respiratory Diseases, Bacteriology and Mycology, Parasitology, Virology, Enteric and Hepatic Diseases, Sexually Transmitted Diseases, and the Office of Biodefense, Research Resources, and Translational Research. This program officer position is critical to the division in ensuring that clinical studies are done in a manner that will be acceptable to the FDA and can be used to support product licensure.
Qualifications
Candidates must be U.S. citizens and demonstrate that they have worked independently in planning, organizing, and conducting biomedical behavioral health or health-related research as well as served effectively in research program administration in these fields.
Clinical pharmacokineticists with clinical and regulatory expertise in clinical drug and/or vaccine development and drug and vaccine safety are preferred.
Candidates with the following experience and skills are desired:
- Expertise in Phase 1 clinical trial design, dose, and dose escalation selection, and protocol development and implementation
- Clinical and nonclinical pharmacokinetic analysis, modeling, and simulations
- PK software (Phoenix WinNonlin, NLME, NONMEM)
- Pharmacokinetics for projects under "Animal Rule" provision
- Design and execution of nonclinical toxicology studies in support of vaccine, macromolecule, and small molecule development
- Bioanalytical assay development and validation
- Solid understanding of good laboratory practices (GLP) and good clinical practices (GCP) regulations
- Pre-IND and IND filings
- Responsible for regulatory preparation of data for submission and presentations at the FDA Advisory Committee
For more information about health scientist administrator positions and qualification requirements, visit Global Recruitment: Recruiting for all of NIH!
Visit NIAID Careers for more information about working in NIAID’s dynamic atmosphere!
HHS, NIH, and NIAID are equal opportunity employers dedicated to diversity, equity, and inclusion.
External website https://www.usajobs.gov/GetJob/ViewDetails/589238100
11th Jan 202 [3037]
UNC/GSK Postdoctoral Fellowship in Pharmacokinetics/Pharmacodynamics
The UNC Eshelman School of Pharmacy and GlaxoSmithKline (GSK) offers a two-year postdoctoral fellowship in pharmacokinetics/pharmacodynamics (PK/PD). The fellowship emphasizes coursework and hands-on experience focused on the application of population and physiologically-based PK/PD modeling and simulation techniques to guide drug development. Fellows spend their first year at the University of North Carolina at Chapel Hill, and the second year at GSK research facilities.
At the completion of the Fellowship, the post-doctoral fellow will be able to:
- Describe the importance of clinical research in drug development;
- Describe the nature and relevance of clinical data evaluations relative to drug development;
- Design and implement studies to examine drug absorption, drug disposition, pharmacodynamic endpoints and drug interactions in healthy human volunteers or diseased patient populations;
- Understand foundational concepts related to population PK/PD and physiologically-based PK modeling and simulation techniques;
- Understand important considerations in clinical trial design and the conduct of clinical investigations in specific patient populations (e.g., pediatrics);
- Perform PK/PD and statistical data analysis using relevant software packages;
- Prepare a manuscript, seminar and other scholarly vehicles for communication of scientific results.
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.
External website http://pharmacydpetfellowships.web.unc.edu/
Contact email address: telder@stem-sourcing.com - 11th Jan 202 [3035]
*REMOTE*Director/Sr. Director Clinical Pharmacology/Clinical PK
Our Client is a clinical stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, This Company’s therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes.
This Company is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver, lung, and solid tumors with a promising pipeline of preclinical candidates.
The Position
This Company seeks a Sr. Director level, Clinical PK/PD specialist to join its Clinical Pharmacology team. This individual will report into This Company’s VP, Clinical Pharmacology/DMPK.
Responsibilities
- Conduct hands-on analysis of clinical or translational PK/PD data, and authorize PK clinical study reports
- Provide PK/PD Modeling & Simulations to support dosing strategies for clinical programs; contribute to clinical pharmacology strategy and planning for clinical programs
- Ensure timely and accurate communication of study results and interpretation with appropriate internal drug development teams
- Ensure high quality of documentation compatible with global regulatory submission requirements
- Maintain a current understanding of small and large molecule PK/pharmacometrics literature and methodology including RNAi therapeutics, and the state-of-art in Model-Informed Drug Development (MIDD)
- PhD (or work-place equivalent) in pharmacokinetics, pharmacology or pharmaceutical science
- 10+ years of pharmaceutical industry experience
- Industrial experience in clinical NCA PK analysis and data reporting using Phoenix WinNonlin and SAS program with familiarity of authorizing PK clinical study report (PK CSR) in submission standard
- Knowledge of FDA/ICH guidance related to NCA and PopPK analysis is required
- Industry experience in clinical-stage drug development is preferred
- Skills in population PK, PK/PD modeling using NONMEM or NLME is highly desired, while PBPK modeling experience is a plus
External website https://www.stem-sourcing.com
Contact email address: vkeyser@aligos.com - 28th Dec 202 [3034]
Principal Research Scientist - DPMK
Aligos Therapeutics, Inc. is a biotechnology company located in South San Francisco, California that is developing novel medicines to treat liver diseases in virology, inflammation/fibrosis and oncology. Aligos is pursuing the development of both oligonucleotide-based and small molecule therapeutics, each addressing major commercial market opportunities.
At Aligos, our science is the key to our success with the ultimate goal of improving patients' quality of life. Our pipeline of developing novel compounds and investigative therapies reflects our commitment to bring innovative products to patients with unmet needs in the area of liver diseases. This is an exciting opportunity to become an employee a high energy Research and Development company. We are looking for an enthusiastic person who understands and appreciates the entrepreneurial environment and who is willing to do what it takes to contribute to the success of the company.
This position is responsible for providing DMPK expertise for new chemical entities, small molecule and oligonucleotides, as a project representative on multi-disciplinary drug discovery and development teams. The candidate will work closely with nonclinical discovery scientist, clinicians and cross-functional project team members. Responsibilities include guiding discovery project teams for candidate selection, developing and driving DMPK strategies for lead optimization and solving ADME-related issue, designing and interpreting in vitro and in vivo DMPK studies. Responsibilities also includes determining PK parameters for nonclinical studies using WinNonlin and assisting with the application of modeling approaches (in silico, PK, PBPK) to support human pharmacokinetics and dose predictions, quantitative risk assessment of drug-drug interactions, monitoring of GLP bioanalysis, and CRO management. To support GLP toxicology and clinical studies, this position is responsible for monitoring methods development, validation, sample analysis and reviewing and approving reports. The candidate will be required to generate, analyze and present data, both orally and as written reports, author and review various regulatory documents and interact with worldwide regulatory authorities.
Qualifications and requirements:
- PhD or Pharm D. in Pharmacokinetics, Pharmaceutical Sciences, or related field with a specific focus on small molecule and oligonucleotide pharmacokinetics and metabolism with 5 to 8 years of relevant industry experience.
- Extensive understanding of DMPK principles. A proven track record of supporting drug discovery and development as a functional representative on multidisciplinary project teams, authoring regulatory documents, supporting worldwide regulatory filings and interactions.
- Proven skills in pharmacokinetic data analysis using Phoenix WinNonlin. Familiarity with NONMEM, SimCyp and/or Gastroplus PBPK modeling is nice to have.
- Knowledge of GLP, GCP, drug development and regulatory guidelines is required.
- The ability to work independently, excellent interpersonal and organizational skills, excellent oral/written communication, proven track record of teamwork, ability to multitask and prioritize to delivery results within
External website https://www.linkedin.com/careersite/aligos
Contact email address: telder@stem-sourcing.com - 17th Dec 202 [3033]
Associate DIrector/Director Quantitative Pharmacology
KEY RESPONSIBILITIES
- Partner with Head of Nonclinical Development, Program Team leaders and R&D staff to lead the pharmacometrics and quantitative PK/PD strategy for discovery and development programs
- As a member of project teams, the individual will be responsible for applying model-based approaches to support compartmental and mechanism-based PK/PD analysis, evaluation of FIH dose and regimen recommendations.
- Develop and execute strategies for mid-stage and late-stage Oncology programs to support regulatory questions and filings
- Provide due-diligence and strategic regulatory advice/evaluations for oncology drug development programs
- The successful incumbent will utilize a range of computational approaches (PK/PD, PBPK, pharmacometrics, systems-based, informatics). The scope of project responsibility will range from late discovery through registration.
- A Ph.D. in a related field with years of relevant experience in modeling and simulation.
- Excellent understanding of PK (NCA, compartmental) and PK/PD principles.
- Expertise in the application of Phoenix WinNonlin, PBPK related software, and R is required.
- Experience with PopPK model development with regulatory reporting is a plus.
- Superior communication skills (both written and oral) and attention to detail
External website https://www.stem-sourcing.com
Contact email address: christine.ahlstrom@astrazeneca.com - 11th Dec 202 [3032]
Are you an expert in mathematical modelling? Would you like to apply your expertise in a company that is accelerating innovative science and turns ideas into life changing medicines? Join us to be part of the development of future treatments of Cardiovascular, Renal and Metabolic diseases!
Working at AstraZeneca means being entrepreneurial, thinking big and working together to make the impossible a reality. We are now recruiting a highly skilled and passionate scientist with expertise in mathematical modelling, preferably applied in the field of pharmacokinetics-pharmacodynamics(PKPD), to join the Modelling & Simulation team within the EarlyCardiovascular, Renal and Metabolism (CVRM) therapeutic area at AstraZeneca. The position is placed at AstraZeneca’s dynamic R&D site in Gothenburg, Sweden.
Early CVRM is one of the three main therapeutic research areas within AstraZeneca which deliver candidate drugs into late-stage clinical development. Early CVRM is a global function with research units in Gaithersburg, US, Cambridge, UK and Gothenburg, Sweden. The Modelling & Simulation team is part of the Drug, Metabolism and Pharmacokinetics (DMPK) department and based in AstraZeneca’s world-class R&D center in Gothenburg Sweden. DMPK interacts with other functions in supporting Early CVRM projects all along the value chain, from target selection all the way to market launch and Life cycle management.
What you’ll do
With a true passion for science you will support our portfolio within the CVRM disease area. You will deliver translational quantitative/PKPD input for a broad range of drug modalities from target identification to life-cycle management. The position can be at Senior Scientist or Associate Principal Scientist level depending on the experience of the successful candidate.
Responsibilities includes:
- Define and deliver the translational quantitative/PKPD strategy in projects from target identification to life-cycle management
- Identify the appropriate mathematical modelling approach (e.g. traditional PKPD modelling, non-linear mixed effects modelling, quantitative systems pharmacology) to deliver the aforementioned
- Design preclinical PKPD studies, contribute to estimation of safety margins and report results and interpretations to project teams and internal governance bodies
- In collaboration with key functions (e.g. bioscientists, translational scientists, safety scientists, clinical pharmacologists and clinical pharmacometricians) integrate the appropriate data to predict human pharmacokinetics, efficacious human drug exposure, human longitudinal response (e.g. biomarker and disease effects), and human dosing regimen
- Communicate scientific progresses both externally and internally
External website https://careers.astrazeneca.com/job/gothenburg/preclinical-and-translational-pk-and-pkpd-scientist/7
Contact email address: robin.michelet@fu-berlin.de - 10th Dec 202 [3031]
The Department of Clinical Pharmacy and Biochemistry of the Institute of Pharmacy at the Freie Universitaet Berlin is currently looking for a:
Postdoctoral Research Fellow (m/f/d)
We are an interdisciplinary, international, research-oriented group applying high scientific standards and innovative methodologies with the ultimate aim to foster the rational use of medicines while empowering young scientists to perform clinically relevant research (http://www.clinical-pharmacy.eu/).
Our group is grounded on two research pillars: (1) Bioanalysis, microdialysis, cell culture, and (2) Pharmacometric (data) analysis. As key feature, the two pillars are bridged, as our pharmacometric projects are based on in vivo or in vitro data obtained by the experimental research pillar, while innovative dynamic in vitro systems utilise modelling and simulation approaches. In addition, many of our projects are realised as parts of clinical studies. Typically, our research is embedded in consortia at a national and international level (EU, global).
We are looking for a full-time postdoctoral fellow in the field of optimising drug therapy and drug development by applying innovative translational modelling and simulation techniques to join our research group for a period of at least 2 years; extension to 5 years is possible. To be eligible for the positions, a PhD and a strong record in the pharmacometric research area is needed. Additionally, experience in either or (i) evaluating pharmacokinetic, pharmacodynamic or systems pharmacology data and pharmacometric analysis with NONMEM, R or similar pharmacometric software, (ii) Bayesian analysis using STAN or similar platforms, or (iii) one of our experimental platforms (LC/MS-MS, microdialysis, bacterial infection models, in vitro metabolism) is required. The positions also offer supervision of PhD and Master/Diploma students.
Applications in English should include a letter of motivation along with a description of research interests and relevant qualifications for the position. In addition, a curriculum vitae including a list of publications and names/email addresses of 2-3 referees should be provided. Please submit your application to: charlotte.kloft@fu-berlin.de and robin.michelet@fu-berlin.de
Project summary
Currently, respiratory tract infections represent the third leading cause of death worldwide (about 3 million deaths per year). Bacterial pneumonia (either community-or hospital-acquired) is a leading cause of morbidity, quality-adjusted life year loss, and mortality in children, adults, and the elderly. In Europe, pneumonia costs €10 billion each year. Although antibiotics have transformed the management and treatment of bacterial pneumonia, their effectiveness is declining -because of antimicrobial resistance (AMR). The World Health Organization (WHO) estimates that bacterial infections due to AMR will outcompete any cause of death by 2050, meaning that it is crucial to develop new strategies to improve antibacterial treatment. In 2017, the WHO defined a priority list of bacteria for which new antibacterial therapies are urgently needed; it includes the major pneumonia-causing pathogens Pseudomonas aeruginosa, Klebsiella pneumoniae, and Streptococcus pneumonia.
The FAIR project (European grant H2020 -call SC1-BHC-14-2019) proposes a unique approach: aerosol delivery of an immunomodulatory protein (by nebulization), achieving direct release into the airways, prompting innate immunity activation in the lungs and preventing systemic immune activation.
Please visit our website, https://www.clinical-pharmacy.eu for more information. The project is included in a research grant program “FAIR” (https://fair-flagellin.eu/) gathering European teams and coordinated by J.C Sirard, Inserm,Lille, France.
Job profile
- Performance and publication of research projects in pharmacometric and translational modelling
- Contribution to EU project “FAIR” of the Horizon 2020 initiative (11 European partners from 6 different countries; Work package 5: Development of a translational modelling and simulation platform for flagellin PK/PD)
- Contribution to conception and realisation of new research ideas and collaborations
- General services in research (co-supervision of junior members; IT/Cluster contact) and research organisation
Requirements:
- Graduation in Pharmaceutical or Life sciences or related field
- Qualified PhD thesis in Pharmacometrics, systems pharmacology or PBPK modelling, preferentially PK/PD modelling of therapeutic proteins
- Profound knowledge in pharmacometrics software: e.g. NONMEM/PsN, Berkeley-Madonna, Monolix, nlmxR or similar
- Good knowledge in the software programs R, PKSim, STAN, Pirana or similar
- In-depth experience in organisation and performance of research projects and in scientific publication in the area of pharmacometrics
- Experience with or interest for in vitro work such as bacterial infection models, in vitro microdialysis or in vitro metabolism experiments.
- High intrinsic motivation/high level of commitment
- Excellent team player
- Strong verbal/written communication skills
- Language skills: English excellent
External website https://fair-flagellin.eu/news
Contact email address: telder@stem-sourcing.com - 3rd Dec 202 [3030]
PK/PD Modeler-Senior Scientist-REMOTE
Our new favorite client is looking for a strong modeler. Phoenix Winonlin, pop pk, NONMEM experience is what is needed. Phd with 2-3 years of experience for MS with 7-10 years of experience would be great. The position can be remote or it can be a hybrid in the future. This is an exciting role at a growing company. Be part of a winning team with great people and great science!
External website https://www.stem-sourcing.com
Contact email address: broseberry@cartermackay.com - 18th Nov 202 [3029]
Head of Pharmacometrics/Sr. Director role available in MA. Will supervise a group. Please contact me for more info.
Senior Director, Head of Pharmacometrics
Position Summary
The Head of Pharmacometrics will be reporting to the Senior Vice President of Clinical Pharmacology and Pharmacometrics. In this position, the head of pharmacometrics is expected to provide strong technical and strategic leadership to a group of talented pharmacometricians and, strengthen and champion quantitative model based drug development across the organization. Will be responsible for pharmacometrics plan, conduct and review of modeling analysis for internal decision making and regulatory filings. Candidate should possess scientific curiosity and a passion for quantitative science based interrogation of data.
Major Duties and Responsibilities
- Strategize, formulate and execute on modeling and simulation strategy for clinical projects with ability to independently plan, design, analyze, interpret and report PKPD modeling results for internal decision making and regulatory filings
- Train, mentor and grow pharmacometrics team members in modeling and simulation skills.
- Responsible for identification of dosing regimen and optimization of dosing for products
- Collaborate and influence decision making pertaining to dosing and clinical trial design on project teams
- Strategize, collaborate cross-functionally with other departments and provide modeling and simulation support
- Formulate pharmacometric strategy and responses to regulatory health authority inquiries on PK, PK/PD, dosing and clinical pharmacology related issues. Represent pharmacometrics at regulatory meetings.
- Enhance role and visibility of pharmacometrics internally within the company and showcase expertise through publications in peer reviewed journals and presentations at scientific meetings
Requirements/Qualifications
- Candidate with a Ph.D (or equivalent) degree in pharmacokinetics, biopharmaceutics or related field
- At least 10 years of pharmacometrics experience in pharmaceutical industry or regulatory agency. Should have hands-on experience and an expert in NONMEM, S-plus, R-, SAS and WinNonlin and should be intimately familiar with the drug development process. Be a team player and a strong cross-functional contributor and partner.
Special Skills/Abilities
- Candidate should possess good understanding of pharmacokinetic and pharmacodynamic principles and have extensive experience in quantitative population PK/PD modeling and simulation using NONMEM
- Candidate should have experience in clinical endpoint, disease progression and mechanistic modeling
- Strong managerial skills with proven record of mentoring and advancing a pharmacometric group
- Candidate should have experience writing clinical pharmacology sections of NDA/MAA and preparation of pharmacometric reports to support regulatory filings
- Strong written and oral communication skills
- Team player with strong interpersonal skills
- Ability to strategize, influence, advance and implement model based drug development. Formulate strategy and engage with regulatory authorities on development proposals particularly around dose selection. Showcase value of modeling and simulation through informed decision making.
- Independent contributor who is able to multi-task and prioritize with minimal supervision. Provide mentoring, strategic and planning support and train pharmacometrics team members in advanced pharmacometric skills. Motivated to promote role of pharmacometrics across the company in a personable, result-oriented and collaborative manner.
Contact email address: telder@stem-sourcing.com - 18th Nov 202 [3028]
Senior Scientist or Entry Level Modeler Role
Responsible for supporting PK/PD, PB/PK, and population PK analysis of data from early discovery through clinical development.- Work with lab-based scientists to design and analyze data generated with in vitro and In vivo PK/PD models to be used in support of clinical exposure targets
- Utilize in vivo allometric and/or in vitro intrinsic clearance data to predict human PK and analysis with PK/PD understanding to inform human dose projections
- Construct population PK model analyses utilizing clinical trial PK and demographic data to be used in support of Monte Carlo simulation and probability of target attainment assessments.
- Conduct modeling and simulation utilizing PK predictions, PK/PD understanding, and data available in the literature
- Assemble posters and presentations for external disclosure including conference attendance
- PhD + 2 to 3 years pharmaceutical research experience or BS/MS with 10+ years of experience
- +5 years of experience in DMPK, PK/PD, or quantitative pharmacology
- Established publication record
- Working knowledge of pharmacokinetic modeling including non-compartmental analysis, non-linear modeling, Population pharmacokinetics / pharmacodynamics (PK/PD) modeling
- Experience with translational mechanism-based modeling, Monte Carlo simulations and physiologically based PK modeling preferred
- Proficiency with modeling software packages NONMEM, Phoenix WinNonlin, MATLAB SimBiology and non-linear mixed effect models/statistical software
- Excellent communication/presentation/Power point skills are required
External website https://www.stem-sourcing.com