Director/Senior Director Pharmacometrics Quantitative Pharmacology
- Accountable for planning and executing state-of-the-art M&S techniques
- Scientific and strategic input into pre-clinical, clinical, and post-approval development plans
- Accountable for oversight, support and delivery of scientific and strategic modeling work related to specific projects
- Support evaluation of drug candidates for in/out-licensing
- Accountable for the identification and development of drug-disease models and other modelling approaches to support internal and external decision making in collaboration with internal and external partners (when relevant)
- Accountable to provide peer review and mentoring of junior staff
- Support and contribute to the development of the quantitative pharmacology in terms of providing training and knowledge sharing
- Monitoring external and internal environment in terms of relevant new methodologies and applications
- Ensure modeling efforts are aligned with current regulatory expectation
- Partner with the Preclinical Pharmacokinetic/Pharmacodynamics Team to enable translational PKPD efforts in the Discovery space
- PhD with 10-15+ years experience in industry
- Significant experience in modelling and simulation including PK, PKPD and statistics
- Demonstrated broad translational and clinical development expertise and experience exemplified by 15 years drug development experience (early and late), with emphasis on Pharmacometrics
- International recognition in the field on pharmacometrics
- Relevant regulatory experience (written/oral)
- Experience in managing and mentoring junior scientists, modelers and pharmacometricians
- Expert knowledge about modeling softwares, MATLAB, NONMEM, WinNonlin etc.
External website https://www.stem-sourcing.com
Contact email address: telder@stem-sourcing.com - 18th May 202 [3002]
Clinical Pharmacology Scientist
Be a subject matter expert in clinical pharmacology and work in tandem with quantitative pharmacology on strategy for the direction of the group and compounds in the pipeline. Contribute to regulatory documents e.g. IND's, NDA's and BLA's. This role requires a PhD with at least 2 years of industry experience. Ability to analyze PK/PD population software such as WinNonlin and NONMEM as well as others.External website https://www.stem-sourcing.com
Contact email address: broseberry@cartermackay.com - 8th May 202 [3001]
Bay Area CA AD/Director role available in Clinical Pharmacology-full time role with established client. please contact me at broseberry@cartermackay.com for more info. Job Details below: This individual will be responsible for the dual development and implementation of both Clinical Pharmacology and Modeling and Simulation (M&S) strategies in support of the company portfolio.
Professional Responsibilities:
- Integrate PK, PD, safety, and efficacy data with M&S methodologies, spanning population (PopPK) to quantitative systems pharmacology (QSP) approaches
- Will support multiple quantitative clinical pharmacology deliverables, both with hands-on contributions and of work conducted by external vendors
- Provide both departmental representation and subject matter expertise on development teams
- Author and/or review documents including clinical protocols, M&S analysis plans and reports as well as study reports, regulatory documents, and journal articles
- Attend and present at internal and external meetings as needed
- Support interactions with worldwide Health Authorities regarding clinical pharmacology issue
- Supervise outsourced studies with external vendors
- Ph.D. in Pharmacokinetics, Pharmacometrics, Engineering, Pharmaceutical Sciences, or related discipline
- 5+ years (10+ for director position) of industry, regulatory, and/or related post-doctoral quantitative clinical pharmacology experience Professional Requirements:
- Demonstrated experience with leveraging M&S approaches (e.g. PopPK, clinical trial simulation, and/ or QSP modeling) to inform drug development
- Excellent verbal and written communication skills and interpersonal skills
- Strong leadership and project management skills
- Hands-on experience with M&S software (e.g. NONMEM, R, MATLAB, and/or SimBiology)
- Regulatory filing experience is highly desirable
Contact email address: cvmopportunities@fda.hhs.gov - 1st May 202 [3000]
Vacancy Announcement
Staff Fellow positions: Clinical Pharmacologist– Division of Scientific Support
The Food and Drug Administration (FDA), Center for Veterinary Medicine (CVM), Office of New Animal Drug Evaluation (ONADE), Division of Scientific Support (DSS) is seeking qualified applicants for several Clinical Pharmacologist positions. DSS provides expertise, leadership, and coordination to all CVM offices regarding biostatistics, clinical pharmacology, and environmental safety evaluations for reviews and research. Through our independent and collaborative reviews and evaluations, we support the Center’s scientific and regulatory goals to approve safe and effective animal drugs. This position will be filled through FDA’s Staff Fellowship program. The appointment is up to 2 years with opportunity for renewal.
This position is located on the Clinical Pharmacology Team within the Division of Scientific Support in the Office of New Animal Drug Evaluation (ONADE). The function of the team is to evaluate the absolute and relative bioavailability of a new animal drug/drug product and the pharmacokinetics (absorption, metabolism, distribution, and elimination) of new chemical entities. You will analyze and interpret these scientific investigations, technical data, opinions, and related information, and make recommendations for Agency action regarding New Animal Drug Applications and Investigational New Drug submissions.
Applicants should have experience evaluating study designs, assay methodology, and sensitivity of the assay method of drug products and pharmacokinetics of chemical entities, performing pharmacokinetics & pharmacodynamics modeling and analysis utilizing software such as WinNonLin, NONMEM, or WinBUGS; and developing written summaries of bioavailability, bioequivalence, dissolution and pharmacokinetic studies.
Due to the immensity of its charge, CVM depends upon a diverse and dedicated workforce. We recognize the importance of multi-disciplinary teamwork in reaching superior and timely regulatory decisions therefore we foster an atmosphere where every employee’s contribution is important. New concepts, ideas, and creative approaches to improve current operations and to meet existing and future challenges are encouraged. Our goal is to not only enable our employees to positively impact the Center today, but to prepare our workforce for the demands, responsibilities, and career opportunities of tomorrow. ONADE offers many benefits and operates in a hoteling work environment. Hoteling is an arrangement where employees reserve non-dedicated, non-permanent workspace at the Rockville duty station on an as-needed basis and as required and telework when not at the Rockville duty station. ONADE provides the basic technology (e.g., laptop, monitors, webcam) needed to effectively work in the Rockville office and in a teleworking location. Hoteling, along with a strong telework program and strong electronic communication and workflow tools, affords employees in ONADE the flexibility to balance work/life demands while contributing to our high performing organization.
The position is located in Rockville, Maryland and is available immediately. The salary range for the GS-12 equivalent level is from $86,335 to $112,240, and for the GS-13 equivalent level from $102,663 to $133,465 based on experience and education. Further information regarding qualification requirements can be found at the following link: http://www.opm.gov/policy-data-oversight/classification-qualifications/general-schedule-qualification-standards/0400/pharmacology-series-0405/.
Please submit your letter of interest, resume, and transcripts to: CVMOpportunities@fda.hhs.gov with the subject line of “PharmPK” – Division of Scientific Support Staff Fellow Pharmacologist Position”. Questions may also be directed to the CVM Opportunities mailbox. **Applications will be reviewed and interviews will be scheduled on a first come, first serve basis.**
FDA is an equal opportunity employer and is a smoke-free environment.
External website https://www.fda.gov/about-fda/center-veterinary-medicine/working-cvm
Contact email address: broseberry@cartermackay.com - 15th Apr 202 [2999]
Sr. Director role in clinical pharmacology available in MA. This is a fantastic first in opportunity. please contact me for more info.
Description below.
- Lead the Clinical Pharmacology strategy to create sound, innovative and efficient programs that meet regulatory requirements, corporate and R&D program goals, and facilitate development from Phase 1 to commercialization
- Provide clinical pharmacology expertise in design and analysis of pharmacokinetic (PK) and pharmacodynamic (PD) aspects of clinical studies, including determining study design details, development of PK/PD models, special populations, dosing, evaluating clinical safety, efficacy, and patient selection strategies and predictive biomarkers
- preparation of the clinical pharmacology portions of regulatory documents such as the pre-IND, IND, IB, briefing documents, clinical study reports, CTA and filing documents, while working in collaboration with cross functional team
- Work with the discovery preclinical DMPK colleagues to optimize preclinical models and inform first in patient clinical dosing strategies
- Perform with adherence to agreed timelines and budgets to ensure execution of deliverables
- Represent Clinical Pharmacology and provide subject matter expertise on cross-functional project teams, clinical study teams and translational medicine teams
- Identify/manage consultants and vendors to support Clinical Pharmacology studies
- Excellent written and oral presentation skills
- Strong critical thinking and the ability to work effectively with cross-functional teams in a matrix environment
- Can work independently with minimal supervision
Job Requirements:
- MD, PharmD, or PhD with at least 10 years of Clinical Pharmacology experience (Level commensurate with experience-can be adjusted)
- Experience in a pharmaceutical or biotechnology industry role is preferred
- Strong understanding of Clinical Pharmacology principles, the drug development process and regulatory requirements to support Clinical Pharmacology strategies
- Proven excellence in applying technical knowledge to strategic planning
Contact email address: telder@stemsourcing.com - 9th Apr 202 [2998]
Clinical Pharmacology Lead
Lead all aspects of clinical pharmacology in the Translational Development group of this mid-sized pharma company. Mentor PhD and non-PhD level scientists as well as contribute individually. Use experience in PK/PD, quantitative modeling and simulation, drug development, TK, and nonclinical PK (DMPK and ADME). Provide expertise and guidance for clinical pharmacology plans with minimal supervision.
Qualifications:
PhD with at least 10 years of experience. Experience leading clin pharm programs and being awesome. Experience with PK/PD analysis on INDs, CTDs, NDAs etc. is required for this role. Experience using modeling and simulation software is also a requirement for this role as well as publications reflecting excellence in the field of clin pharm.
For more information on this role reporting to the Vice President of this group.
External website https://www.stem-sourcing.com
Contact email address: broseberry@cartermackay.com - 8th Apr 202 [2997]
New Director/Sr. Director role in Pharmacometrics available. Please email me with questions at broseberry@cartermackay.com
The Director/Sr. Director,will provide strategic and scientific expertise, as well as represent the dept. within the organization. This position will be accountable for developing and applying quantitative frameworks that enable model-informed drug discovery and development across the company portfolio. In addition, this position will ensure robust quantitative data and quality in all deliverables through direct scientific mentorship and management of other QP professionals.
Responsibilities
- Assist in the leadership of the department, and directly manage other QP professionals
- Lead and supervise all model-based activities and provide direct hands-on modeling expertise on select programs
- Develop and execute comprehensive quantitative pharmacology strategic plans as well as internal and regulatory decisions
- Work closely with Clinical Pharmacology colleagues to develop and deliver quantitative strategies to support assigned development plans
- Provide quantitative pharmacology and disease area subject matter expertise to Discovery and Development teams; influence the collection and use of nonclinical and biomarker data to inform human pharmacology, dose selection, and study design
- Oversee the development and execution of modeling analysis plans to support regulatory/submission deliverables
- Responsible for overseeing and guiding the scientific basis, predictiveness, and biological suitability of models and methods developed within team through mentoring scientists in conjunction with relevant disease pharmacology/biology as well as review of model code, diagnostics,
- Work closely with Clinical Pharmacology and Regulatory to provide appropriate quantitative pharmacology content to regulatory documents, communications and presentations as needed (IND, health authority inquires, preparation/participation in meetings with health authorities, preparation of BLA summary sections, addressing review inquiries, health authority sponsored Advisory Committee Meetings, etc.)
- Oversee preparation and review of PopPK, PKPD, ER, and other quantitative pharmacology reports and publications. Work with Clinical Pharmacology and Medical Writing to incorporate QP sections into clinical study reports
- Partner with the Preclinical Pharmacokinetic/Pharmacodynamics Team to enable translational PKPD efforts in the Discovery space
- PhD in Engineering, Pharmaceutical Sciences (PKPD emphasis) or other computational/quantitative discipline
- a minimum of 8 years of experience in the application of quantitative pharmacology
- Expertise in population analysis methodologies; knowledgeable in the use of computational tools including NONMEM, Monolix, R, Matlab, etc.
- Experience in mechanistic/semi-mechanistic pharmacological modeling as well as development of exposure-response, PKPD, disease, and/or QSP models is strongly preferred
Contact email address: broseberry@cartermackay.com - 3rd Apr 202 [2996]
Discovery/Preclinical PK/PD role in biologics available, east coast US. Job description: (level will be based on experience--ideally someone coming out of a post doc up through mid level)
- Participate inn Discovery-stage project teams as a subject matter expert for Preclinical Pharmacokinetics/ Pharmacodynamics, providing PK or PK/PD input to the design of preclinical PK/pharmacology studies.
- Work with various groups and PK/PD management in order to develop a PK strategy for each project.
- Effectively communicate project team queries, requests and expectations (i.e. timing and deliverables) from the Project Teams to subordinates and management.
- Execute and report PK and PK/PD analyses
- Work in close association with the Toxicology, Pathology, Clinical Pharmacology (CP) and Quantitative Pharmacology (modeling & simulation) functions, within the Drug Safety and Pharmacometrics (DSP) Department.
- Maintain an up-to-date knowledge of the relevant scientific literature as well as regulatory guidances and best practices as they pertain to PK/PD.
Requirements
- PhD in Pharmacology, Pharmacokinetics, Biology/Molecular Biology, Biochemistry,.
- Previous experience with protein/monoclonal antibody therapeutics is required.
- In-depth theoretical and applied understanding of PK and PD, in order to describe and understand the pharmacology/biology of therapeutic proteins, is required.
- Demonstrated ability to plan, organize, oversee PK and/or PK/PD studies, and analyze PK/PD data is essential.
- Excellent communication (written/verbal), presentation and leadership skills are required.
Demonstrated scientific creativity is required, together with the ability to propose innovative solutions. - Experience in drafting PK reports and IND's is desirable. please email me for more info
Contact email address: broseberry@cartermackay.com - 31st Mar 202 [2995]
Associate Director, Clinical pharmacokinetics available in southern CA with an established client. please contact broseberry@cartermackay.com for more info
The Clinical Pharmacologist is responsible for providing expertise including, pharmacokinetics (PK), pharmacodynamics (PD) to programs in all stages of development, ranging from pre-New Molecular Entity (NME) declaration through post-marketing support. Will be responsible and accountable for developing compound specific Clinical Pharmacology Development Plan and will apply and promote Clinical Pharmacology knowledge, including that of model-based drug development, in the programs they support for all stages of drug development. Will independently execute the day to day operations for the clinical pharmacology aspects of the assigned programs by managing directly or indirectly teams of employees of different levels.
Key Responsibilities:
Contribute to overall compound development via application of quantitative methods to integrate knowledge of PK, PD, patient characteristics, disease states, and drug—drug interactions to optimize dose selection, dosage regimens and study designs throughout drug development. Will be responsible for appropriate summarization and interpretation of results of PK/PD analyses with respect to their impact on development and clinical use of drugs. Independently or with assistance, clinical pharmacologists will translate quantitative knowledge into strategic opportunities with key stake holders to drive development along the model-based drug development principles.
- Accountable for all modeling and simulation activities in the program. Perform and/or liaise for modeling and simulation analysis of preclinical-clinical data, translational PK/PD data, up to first-in-human (FIH) and if applicable beyond FIH (dose/exposure-response analyses to guide dose regimen from pre-proof of concept (POC) studies and POC studies); Whenever appropriate perform and/or provide input and guidance to the prediction of clinical response and study outcomes of Phase 2b, and Phase 3 trials and to optimize trial designs. Consider alternate and appropriate dosing recommendations for special situations (e.g., drug interaction, food effect, pharmacogenomics effect, pediatric, elderly, renal impairment, hepatic impairment).
- Partner with functional representatives in biology, chemistry, biomarker, translational medicine, CDTLs and clinicians to develop CPDP and design suitable early PKPD plans on projects
- Engage discovery project teams early to aid in PKPD, biomarker, and efficacious dose prediction strategies
- Design and execute PKPD modeling efforts to address the unique challenges pertinent to the project
- Contribute to preparation of monographs, INDs and other documents as applicable to support clinical studies
- Seamlessly transfer project knowledge/assets to the relevant team upon FIH (or an alternative mutually agreed upon point)
- Where applicable, find common areas of need across projects (and possibly across TAs) that could benefit from a common modeling approach/platform
- Mentor other CP colleagues in the science of preclinical PKPD modeling, simulation and efficacious dose prediction
- Remain current with clinical and drug development information and methods in modeling and simulation by engaging with the scientific community (e.g., publishing, presenting at meetings, participating in special interest groups within professional societies, etc.) and internalize key learnings back to Janssen
- Develop key product differentiation strategies based on a compound’s key attributes and relevant therapeutic landscape in CPDP; subsequently continue to liaise with key functional partners to provide product differentiation strategies throughout the drug development continuum.
- Define regulatory strategy for CP and prepare CP contributions to regulatory documents including IBs, IND’s, briefing books, NDA / MAA submissions, bridging documents, post-approval filings, and responses to health authority questions and where appropriate represent CP in relevant external regulatory meetings (eg, End of Phase 2, pre-NDA / MAA, Advisory Committee meetings).
- When requested, participate in the evaluation of potential business development opportunities.
- Present and/or publish scientific data at conferences and in peer-reviewed journals, stay abreast of new emerging technologies in relevant scientific fields; identify new opportunities for applied scientific and technical advancement within the division.
- Work effectively in matrix environment, managing CP deliverables in accordance with timelines and overall project goals.
- Apply appropriate regulatory (eg: FDA, EMEA, ICH etc) guidelines in the design of clinical development plans and studies.
PhD, MD, PharmD or equivalent degree in Pharmaceutical Sciences, Clinical Pharmacology, Biomedical Engineering, or relevant Biological Sciences with a minimum of four (4) years of pharmaceutical development experience with at least 3 years of relevant experience performing progressively advanced duties at the Senior Scientist level and 5+ years experience for the Associate Director level.
Experience and Skills:
Demonstrated understanding of overall process of drug development and the overall pharmaceutical R&D process is required.
Has established a strong level of expertise and scientific reputation through multiple publications and presentations, preferred.
External website https://na
Contact email address: jchapman@haallc.com - 26th Mar 202 [2994]
Check out this new opportunity from one of our top clients. Below is a brief description of the role.
Job Description
The Scientist/Director will lead the clinical pharmacology activities on a multi-disciplinary team.
Responsibilities
- Design and implement clinical pharmacology studies and strategies for the team.
- Analyze PK/PD data and interpret the results.
- Support translational efforts in support of clinical development plans.
- Contribute to regulatory activities and help maintain overall compliance in the group.
Job Requirements
- Ph.D. in Clinical Pharmacology, Pharmacometrics, Pharmaceutical Sciences, or related field.
- 5+ years of industry experience.
- Clinical pharmacology expertise in translational medicine and drug development.
- Experience analyzing PK/PD data using modeling and simulation expertise.
If you are interested in learning more, please reach out to me at jchapman@haallc.com.
Contact email address: jchapman@haallc.com - 26th Mar 202 [2993]
Check out this new opportunity from one of our top clients. Below is a brief description of the role.
Job Description
The Sr. Director will lead the clinical pharmacology activities on a multi-disciplinary team.
Responsibilities
- Design and implement clinical pharmacology studies.
- Perform model-based analysis of PK/PD and exposure-response data to support dosage selection.
- Develop models to evaluate disease progression and trial design performance.
- Contribute to the clinical pharmacology sections of trial protocols and reports, brochures, and regulatory submissions.
Job Requirements
- Ph.D. in Clinical Pharmacology, Pharmaceutical Sciences, or related field.
- 10-15+ years of industry experience.
- Clinical pharmacology expertise in the oncology therapeutic area.
- Experience analyzing PK/PD data using modeling and simulation expertise.
- Expertise with modeling tools such as NONMEM, WinNonlin, SAS, and MATLAB.
If you are interested in pursuing further, please reach out to me at jchapman@haallc.com!
Contact email address: jchapman@haallc.com - 26th Mar 202 [2992]
Check out this new opportunity from one of our top clients. Below is a brief description of the role.
Job Description The Director will lead the clinical pharmacology activities on a multi-disciplinary team.
Responsibilities
Design and implement clinical pharmacology studies.
Perform model-based analysis of PK/PD and exposure-response data to support dosage selection.
Develop models to evaluate disease progression and trial design performance.
Contribute to the clinical pharmacology sections of trial protocols and reports, brochures, and regulatory submissions.
Job Requirements
Ph.D. in Clinical Pharmacology, Pharmaceutical Sciences, or related field.
8-10+ years of industry experience.
Clinical pharmacology expertise in the oncology therapeutic area.
Experience analyzing PK/PD data using modeling and simulation expertise.
Expertise with modeling tools such as NONMEM, WinNonlin, SAS, and MATLAB.
If you are interested in pursuing further, please reach out!
Contact email address: david.anderson1@takeda.com - 25th Mar 202 [2991]
The DMPK department at Takeda, Cambridge, MA is seeking a highly motivated Scientist to join the Drug Transporter group. The primary responsibilities will include the assessment of NCEs as a potential substrate and inhibitor of drug transporters using various cell-based assays to support projects in early discovery and development stages. A strong understanding of the role of drug transporters in drugs’ ADME and enzyme-transport interplay is critical to this role.
The position level will depend on the level of experience in the relevant areas.
Duties and Responsibilities
- Handle and maintain mammalian cell culture,
- Conduct cell permeability experiments and in vitro drug transporter studies using various platforms including stably transporter-overexpressed mammalian cells, primary hepatocytes, and membrane vesicles, etc.,
- Conduct drug transporter substrate and inhibition assays using radiolabeled and non-radiolabeled probe substrates,
- Hands-on experience in operation, maintenance and troubleshooting of HPLC and LC-MS/MS, and
- Independently design and execute experiments, analyze, critically interpret and document data in reports
- Applicants should possess a PhD, MS, or BS in Biological Sciences/Pharmaceutical Sciences or in other relevant field with 0-2 years (PhD), 6+ years (MS) or 8+ years (BS) of pharmaceutical industry experience.
- Hand-on experience in cell culture of mammalian cells and primary hepatocytes. Prior experience in running permeability and drug transporter substrate/inhibition assays
- Strong background in using and troubleshooting HPLC and LC-MS/MS for small molecules, peptides, and proteins
- Good understanding of the role of drug transporters in ADME, transporter-mediated drug-drug interactions (t-DDIs) and enzyme-transporter interplay
- Experience in utilizing radiolabeled material in drug transporter studies.
- Previous experience in handling new therapeutics modalities including peptides, proteins and anti-sense oligonucleotides (ASOs) will be preferred.
- The candidate must be able to design and interpret data independently and maintain detailed, accurate and comprehensible study documentation.
External website https://takeda.wd3.myworkdayjobs.com/External/job/Boston-MA/Associate-Scientist---Scientist-I---Drug
Contact email address: amir.youssef@synteract.com - 20th Mar 202 [2990]
An Associate Director, Pharmacokinetics position is open at Synteract. The position can be office-based or remote-based in the US.
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 Associate Director, Pharmacokinetics will be responsible for conducting PK/PD modeling and population PK analyses using WinNonlin, NONMEM and/or PKSim with a focus on designing optimal dosing regimens for adult, pediatric 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.
Specific tasks would include:
- Conduct PK/PD analyses, modeling and simulation in WinNonlin, NONMEM and/or PK-Sim for adult, pediatric and 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 data sets for import and analysis in WinNonlin and/or NONMEM.
- Conduct non-compartmental (NCA) and compartmental PK analysis is Phoenix WinNonlin -PKSo.
- Responsible for locking and unlocking studies/scenarios in the PKSo database following management authorization.
- Writing stand-alone PK reports and PK study report sections for CSR’s
- Responsible for ensuring study data and study reports are retained according to the corporate records retention policy.
- Ensuring corporate quality policies and SOPs are followed during the analysis and reporting of PK studies
- Provide pharmacology, pharmacokinetic and drug development consulting services to clients with a specialization in pediatric drug development.
- Ph.D./ Master's Degree in Pharmacokinetics or Pharmaceutical Sciences, plus knowledge of how to support pediatric Pharmacokinetic/Pharmacodynamic modeling and simulations, specifically population PK and/or PBPK with 2-5 years of experience (including Industrial or academic post-doctoral training).
- Candidate must have knowledge of nonlinear mixed effect modeling and hands-on modeling experience using NONMEM
- Intermediate knowledge of GCPs, ICH guidelines, FDA and other applicable country regulations.
- Intermediate proficiency in Microsoft Word, MS Project, Excel, and PowerPoint, Outlook.
- Effective verbal and writing skills, English + local language, if relevant.
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.
Please apply at https://www.synteract.com/Careers/Career-Opportunities
External website https://www.synteract.com/Careers/Career-Opportunities
Contact email address: telder@stem-sourcing.com - 17th Mar 202 [2987]
The Clinical Pharmacology Leader is a highly scientific role, supporting study design, PK and PK/PD analyses, and overall drug development support. 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.
- Collaborates with colleagues in bioanalytics, biometrics, clinical development, drug metabolism and pharmacokinetics, toxicology, and regulatory affairs for clinical studies.
- May have the ability to manage and mentor junior scientists and help grow the clinical pharmacology team.
- Ph.D. in Pharmacokinetics, Pharmaceutical Sciences, or other life sciences with experience in the Biotechnology/ Pharmaceutical Industry or post-doctoral training.
External website https://www.stem-sourcing.com
Contact email address: lienqu@pcom.edu - 3rd Mar 202 [2986]
PCOM School of Pharmacy is currently seeking a qualified individual for one full-time, Assistant / Associate Professor, tenure-track faculty position in the Department of Pharmaceutical Sciences specializing in pharmacokinetics, pharmacology, and/or biopharmaceutics/pharmaceutics. The job location is at PCOM Georgia in Suwanee, GA (metro Atlanta area).
Essential Duties and Responsibilities Duties and responsibilities include (but are not limited to) the following:
Teach in the Doctor of Pharmacy curriculum on topics related to pharmacokinetics, pharmaceutics, and dosage forms along with other areas of pharmaceutical sciences as part of a team-taught curriculum.
Develop and maintain an extramurally funded research program and participate in a collaborative, interdisciplinary research environment with other faculty in the school of pharmacy.
Contribute to the service needs of the school, participating on school and college-wide committees, and in student advising.
Other duties as assigned.
Education: A Ph.D. in Pharmacokinetics/ Pharmaceutical Sciences / Pharmaceutics or a closely related discipline required.
A B.S. degree in pharmacy or PharmD. is preferred but not required.
Experience: 2 years of postdoctoral training or teaching experience
Desirable qualifications at the Assistant Professor level include: Postdoctoral experience in pharmacokinetics. Prior academic teaching experience. Successful record of peer-reviewed publications in pharmacokinetics. Evidence of an ability to establish an extramurally funded research program.
Desirable qualifications at the Associate Professor level include: Prior teaching experience at the Assistant Professor level in a School of Pharmacy.
Proven record of scholarship in pharmacokinetics.
Establishment of independent extramurally funded research program.
All inquiries MUST include:
A letter of intent
Teaching and research philosophy
A curriculum vitae
Salary requirements
Three (3) references, preferably from current or former supervisors.
External website https://www.pcom.edu/about/departments/human-resources/career-opportunities/
Contact email address: david.anderson1@Takeda.com - 24th Feb 202 [2985]
Job Description
The DMPK department at Takeda, Cambridge, MA is seeking a highly motivated Scientist to join the Drug Metabolism group. The primary responsibilities will be profiling and characterization of metabolites (small molecules)/catabolites (ADCs, proteins, and peptides) from complex biological matrices. A strong background in delineating biotransformation pathways and structural elucidation by LC-MS is required. A successful candidate must exhibit strong communication and interpersonal skills and desire to work in a fast-paced, flexible and dynamic environment. Experience with in vivo preclinical and clinical ADME studies and understanding of clearance route, mechanism and the role of metabolism/catabolism is essential.
External website https://http://bit.ly/Takeda_DMPK
9th Feb 202 [2984]
Postdoctoral Fellowship in Pharmacokinetics/Pharmacodynamics
UNC Eshelman School of Pharmacy University of North Carolina at Chapel Hill
A postdoctoral research associate position is available to work on a project focused on characterizing the pharmacokinetics of drugs in children with obesity. The project will involve the use of physiologically-based pharmacokinetic (PBPK) and population pharmacokinetic (PopPK) modeling techniques to identify optimal drug dosing for children with obesity.
Educational requirements: PharmD, MD, or PhD with knowledge of pharmacokinetic/pharmacodynamic analyses.
Qualifications and experience: demonstrated software proficiency (e.g., PK-Sim®, NONMEM®, R) is preferred. 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.
External website https://unc.peopleadmin.com/postings/176772
Contact email address: matt_laughon@med.unc.edu - 7th Feb 202 [2983]
The Division of Neonatal-Perinatal Medicine at UNC - Chapel Hill is recruiting for a fixed-term, full time faculty position. This position will provide support in the design and preparation of clinical pharmacokinetics development strategies and study protocols, perform pharmacokinetic (PK) and pharmacodynamics (PD) analyses, prepare clinical study reports and integrate summary documents. This position will also conduct and coordinate the PK/PD analysis and statistical effort for clinical trials at all stages of drug development.
Educational requirements: PharmD, MD, or PhD in pharmaceutical sciences or pharmacology.
Qualifications and Experience: Candidate should be proficient in PK/PD or related analyses and extensive knowledge of Winnonlin and NONMEM software required. Demonstrate technical expertise of clinical trial simulations and pediatric drug development. Knowledge of clinical database, PK/PD compilation and manipulation with scripting software of SAS, STATA.
Contact email address: telder@stem-sourcing.com - 4th Feb 202 [2982]
Director of Quantitative Pharmacology
The Director will combine strong pharmacometric skills with a deep biological understanding. They are responsible for independently determining, planning, and executing M&S analyses for an entire drug development program in close collaboration with cross-functional colleagues within the R&D organization. Specific experience and interest in working in population PK/PD or quantitative systems pharmacology is required. The Director determines, plans, and executes technically challenging analyses by using state of the art Modeling & Simulation methodologies to strongly contribute to critical decision making. The Director will lead M&S projects for an entire drug development program to evaluate study design, dose selection, probability of success estimation, portfolio strategy, pediatric extrapolation etc. In this role, it is expected that they will represent M&S with cross-functional drug development teams, proactively advocate for model-based approaches, and clearly communicate M&S results. KEY RESPONSIBILITIES:- Independently determines, plans, executes, and interprets modeling analyses for an entire drug development program aligned with the program strategy
- Closely collaborates with the Modeling & Simulations senior director
- Represents M&S on cross-functional drug development teams, proactively advocating model-based approaches to address development challenges
- By using state of the art Modeling & Simulation methodologies strongly contribute to decision making at critical milestones based on quantitative principles in close collaboration with Biostats, Clin Pharm and other quantitative disciplines
- Represents M&S in preparation for regulatory responses and external regulatory interactions
- Represents the department in company-wide, non-scientific initiatives
- Proactively incorporates and develops approaches and methodologies based on review of relevant scientific literature
- Supervise and mentor junior scientists
- Perform population PK, PKPD-analyses, Clinical trial simulations and other model based analyses on a regular basis
- Coordinate outsourced Modeling & Simulation activities when appropriate
- Strengthen our internal Modeling & Simulation capability on a continuous basis by initiating training activities, evaluating and incorporating new M&S tools as appropriate.
- Demonstrate effective communication and leadership to a broad audience with diverse backgrounds, including senior management
- PhD in Pharmaceutics, Clinical pharmacology, or other quantitative discipline with an emphasis Pharmacometric methodologies
- Minimum of 10+ yrs of industry experience in the application of Pharmacometrics within the context of drug development.
- Expert hands-on skills from population-based PKPD modeling, Clinical trial simulation and optimal design, probability of success calculations, Disease progression modeling, Meta analyses etc.
- A solid understanding of fundamental pharmacokinetic and quantitative pharmacology (PKPD) principles.
- Excellent programming skills (NonMem, R, Phoenix, SAS and other similar tools)
- Demonstrated strong leadership- and influencing skills
- Excellent collaborative, verbal and written communication skills
- Experience from Regulatory interactions and guidelines relevant for M&S
External website https://www.stem-sourcing.com
Contact email address: broseberry@cartermackay.com - 29th Jan 202 [2981]
Sr. Manager/Assoc.Director, Clinical Pharmacology role available in MA. Please send resume or questions to broseberry@cartermackay.com
The Senior Manager/Associate Director of Clinical Pharmacology will be responsible for all aspects of the clinical pharmacology strategy including early (Phase 1) and late stage development (Phase 2/3 and NDA filings). This individual will provide strategic leadership and execution of clinical development plans that include characterization and prediction of the pharmacokinetics, pharmacodynamics, and drug metabolism of the drug candidate in selected preclinical and all clinical areas. She/he will also provide rationale for dose regimen selection, safety margin assessment and identification of circumstances where dose adjustment or patient selection/stratification should be considered.
Key Responsibilities
- Plan, prepare and review drug development plans and regulatory filings
- Determine scope, design, and planning and analysis of phase 1-4 pharmacokinetic (PK) and pharmacodynamic (PD) studies, and modeling/simulations required from a drug development and regulatory perspective to take a project from concept to commercialization. Responsibilities include describing results of these studies in regulatory documents (IND’s NDA’s, IB’s, etc.)
- Responsible for protocol design, study planning, review, data analysis / interpretation, and reporting of individual studies implemented to support clinical pharmacology components of project plans
- respond to regulatory inquires related to DMPK, PK/PD, and clinical pharmacology
- Ensure appropriate PK/PD analysis including population PK, PK/PD modeling and simulation, meta-analysis, mechanistic modelling, disease state modelling as required to aid in data interpretation, trial design and/or program decision-making
- Participate in writing publications and making scientific presentations consistent with development strategies and publication plan
- Collaborate with preclinical development colleagues on the scientific/technical aspects of assigned studies from conception through final report, including protocol development, budget, timelines, sample handling/processing, bioanalysis (through CRO), and PK data analysis/interpretation
- Maintain knowledge of relevant scientific and regulatory practices, guidance and trends, and ensure that clinical pharmacology aspects of development programs are contemporary Qualifications
- PhD, PharmD or equivalent training in pharmaceutical sciences, pharmacokinetics, mathematics, or a related scientific discipline is required
- For Sr. Manager, minimum of 3 years of experience in clinical pharmacology, clinical PK/PD or pharmacometrics in the biopharmaceutical industry is required for the Senior Manager level. A minimum of 6 - 8 years of relevant experience is required for the Associate Director level
- Extensive understanding and hands-on experience with Modeling and Simulation (M&S) techniques in drug development (ie. PK/PD, PB/PK, systems modelling, mechanistic modeling, population PK)
- Experience preparing regulatory documents, such as IND’s and NDA’s, as well as prior direct involvement with major regulatory filings
- Expertise in providing relevant vendor and consultant oversight
- Thorough knowledge and understanding of Good Clinical Practices (GCP), the clinical research drug development process, clinical investigational trials, and corresponding roles and activities
- Excellent written and verbal communication skills. Ability to create high quality written reports and summary documents for use in regulatory submissions
- Ability to work independently and in multi-disciplinary teams
Contact email address: patrick.augustijns@kuleuven.be - 21st Jan 202 [2980]
KU Leuven invites applications for a full-time tenured academic position in Pharmacometrics at the Department of Pharmaceutical and Pharmacological Sciences. We are looking for a dynamic and motivated individual (m/f) with an excellent research record and extensive experience in this field. The Department of Pharmaceutical and Pharmacological Sciences includes all medicines related disciplines from validation of a target to the safe use of a drug by the patient. While modelling and simulation are currently applied within several research units of the department, there is a clear need for the implementation of expertise and vision in the field of model-based drug development.
External website https://lnkd.in/daEUXJw
Contact email address: broseberry@cartermackay.com - 17th Jan 202 [2979]
Senior Director CLinical Pharmacology (2 roles, one in the bay area and one in MA) inquiries and interest to: broseberry@cartermackay.com
The Senior Director of Clinical Pharmacology is expected to lead a team of clinical pharmacologists and provide technical and strategic leadership on issues related to clinical pharmacology and pharmacokinetics and pharmacodynamics (PK/PD) from the discovery stage up to the post marketing support (PMS) stage. The overall responsibilities include providing Clinical and non-Clinical Pharmacology functional line leadership and oversight in designing and executing, within the regulatory framework, non-clinical DMPK and toxicokinetic (TK) studies during the discovery phase, and FIH, POC, Phase 1 to 4 studies during the clinical development phase for R&D projects. The responsibilities also include managing company’s technical and strategic needs for conducting in-licensing activities. The incumbent is responsible for ensuring Clinical Pharmacology support and is expected to actively participate in the key decisions at the R&D governance milestones. The incumbent is expected to have hands-on knowledge and ability to strategically guide and contribute to model and simulation based quantitative assessments. At the non-clinical stage the incumbent is responsible for providing leadership on key milestones up to IND filing by collaborating with toxicology and biomarker functions to enable selection of dose/regimen for FIH studies for all research programs. At the clinical stage the incumbent is responsible for authoring and strategizing clinical pharmacology development plans, identifying Phase 2/3 dose regimens by collaborating with Pharmacometrics and other disciplines, providing strategic ownership and direction to the authoring and review of protocols, reports and integrated summaries submitted to the regulatory authorities and interacting with the regulatory authorities. The responsibilities also include managing the department resources and budgets at a therapeutic area level. At the enterprise level, the expectation is to provide leadership in functional compliance and cross-functional collaboration on companywide initiatives related to productivity, innovation or efficiency.
Principal Responsibilities
- Provide clinical pharmacology leadership on project team(s) and collaborate across all areas of early development and clinical development functions. Responsible for the preparation of the clinical pharmacology development plan and provide input into the integrated clinical development plan (ICDP)
- Responsible for the preparation of the clinical pharmacology (including bioanalytical) sections of early and late-stage clinical protocols and PK/PD modeling & simulation data-analysis plans
- Contribute to the design of early phase clinical trials (FIH to POC) and ensure that project goals are met
- Accountable for recommending the starting dose in FIH trials based on allometric scaling or physiologically based PK-PD modeling using nonclinical PK/PD data
- Lead assessments of relevant exposure vs. response data for supporting dose selection during and post POC
- Contribute to the design of late-stage clinical trials to ensure that project goals are met
- Lead the recommendation and presentation at the governance meetings for the starting dose in Phase II and III clinical trials based on PK/PD, efficacy and safety data analysis from previous studies.
- Accountable for the pharmacokinetic and PK/PD data analyses using WinNonlin, NONMEM and/or other software for such analyses
- Responsible for the preparation of clinical PK/PD reports and/or clinical PK/PD sections of the CSRs
- Contribute to the preparation of the clinical pharmacology sections of pre-IND, IND, IB, IMPD and other regulatory documents
- Represent the Clinical Pharmacology function at meetings with regulatory agencies
- Conduct clinical pharmacology-based assessment of in-licensing opportunities
- PhD in field related to Pharmacokinetics and 15+ years of industry experience in Drug Development.
- Advanced knowledge of and hands-on experience in the area of PK/PD/Immunogenicity, modeling and simulation and drug development in multiple therapeutic areas.
- Experience across the development phases is a must.
- Extensive experience in developing the strategy & designing, directing & implementing clinical pharmacology plans for compounds, both biologics and small molecules.
- Knowledge of the current practices and issues in the bioanalytical, biopharmaceutics, nonclinical metabolism and pharmacokinetics, safety pharmacology and toxicology areas
- Technical and practical knowledge of global regulations, regulatory guidances, ethical issues associated with clinical studies and drug development SOPs
- Proven track record of successfully delivering regulatory documents (reports, INDs, briefing documents, CTD/MMAs etc.) and representing company at the regulatory agencies, e.g. pre-IND, EOP2, pre-NDA, labeling and advisory committee and/or oral hearing meetings.
- Established track record of leading team(s) of scientists and mentoring direct reports in the area of Clinical Pharmacology.
- Proven record of simultaneously managing and completing multiple complex projects independently and through direct reports.
- Established track record of scoping and executing due diligence activities at all stages of development. Experience in executing strategy and operational aspects of mergers and acquisitions.
- Strong communication, leadership and people interaction skills, while working in a highly matrixed environment. Knowledge of managing departmental budgets and company level multi-year business
Contact email address: telder@stem-sourcing.com - 7th Jan 202 [2978]
Associate/Director, Clinical Pharmacology/Pharmacometrician
The Director, Clinical Pharmacology/Pharmacometrics will join a dedicated team of clinical development professionals and be responsible for all aspects of clinical pharmacology with focus on PKPD, population PKPD and regulatory interactions. They will be instrumental in dose selection and dose optimization efforts through analyses of PKPD data. They will be interfacing with various groups internally and externally with CROs and alliance partners to ensure proper support for programs and studies. The individual in this role will work with minimal supervision and participate in KOL and regulatory meetings. They will provide strategic and scientific direction and be diligent in delivery of key CP project goals. Responsibilities: Lead pharmacometric aspects of clinical development plans across multiple projects. Hands on pharmacometric modeling, including exposure-response, disease modeling, and population modeling. Serve as a primary source of scientific support for the design, analysis, reporting, and presentation of pharmacokinetic and pharmacodynamic results from clinical studies. Contribute to clinical study designs including first-in-human, human mass balance, bioavailability and/or bioequivalence and drug-drug interaction studies. Develop submission ready summaries of modeling results and interpretations for regulatory documents (IND, NDA, IB, etc). Familiarity of FDA and EMA, and ICH guidance documents including GXp regulations on current practices in the areas of POPPK, PKPD, ADME and clinical pharmacology. Responsible for contributing pharmacometric and clinical pharmacology components of regulatory submissions and responses to questions from regulatory agencies. Oversight of M&S CROs and consultant relationships to ensure capacity to respond to program needs at all stages of development Candidate is expected to work independently with minimal supervision. Mentor colleagues in the department. Strong communication, organizational and interpersonal skills, and ability to manage projects and team members in a matrix environment. Basic Qualifications: PhD. in pharmacokinetics or related discipline with 5 to 8 years of relevant industrial experience Experience (1-2 years) demonstrating regulatory submission with NDA and INDs and responses to regulatory clinical pharmacology/pharmacometric questions. Preferred Qualifications: Strong scientific background in pharmacokinetics, pharmacodynamics and drug disposition sciences Experience in population PK, PKPD, M&S utilizing software such as NONMEM, Monolix, R, Gastroplus/Simcyp/PKSim is desirable. Experience working with external vendors and CROs. Problem solving and organizational skills with attention to detail. Strong team player and strong motivational skills.External website https://www.stem-sourcing.com
Contact email address: yingfeili803@msn.com - 12th Dec 201 [2977]
Novartis Analytics Internships 2020
Location: East Hanover, NJ; Cambridge, MA Number of Positions: Multiple Type of Student: Graduate, PhD Deadline for Applying: January 31, 2020
At Novartis, we are reimagining medicine to improve and extend people’s lives. We have one of the most diverse product pipelines in the pharmaceutical industry and performance-driven professionals are bringing innovative medicines to life.
The department of biostatistics and pharmacometrics at Novartis will have multiple internship positions available for approximately 12 weeks in 2020 (May to August; dates flexible).
Job Description:
Interns will work on statistics, pharmacometrics or data science projects to design and analyze clinical trials and/or perform relevant quantitative research under the guidance of experienced quantitative scientists. Various real-world problems will give interns hands-on exposure to the early and late phases of drug development across different therapeutic areas, including oncology, cardiology, immunology, neurology, ophthalmology, and respiratory care. Potential topics include machine learning (e.g. deep learning), survival analyses, causal inference, Bayesian statistics, disease progression modeling, and/or PK/PD modeling. Interns will also attend seminars and other activities to enhance their understanding of the drug development process. There will be opportunities for interns to present their project results to quantitative scientists and other key stakeholders.
Requirement:
Candidates must be enrolled in a graduate – level program working toward a PhD in biostatistics, statistics, pharmacometrics, engineering, mathematics, or a related quantitative discipline and have completed at least 1.5 years of course work. In addition, candidates must be authorized to work in the United States.
Competitive candidates must have the following skills:
- Strong knowledge of R, working knowledge of Rmarkdown, Rshiny and SAS
- Strong background in NONMEM, MONOLIX, Python and/or other software/language
- Strong problem-solving skills
- Excellent oral and written communication skills
10th Dec 201 [2976]
Dear Colleagues,
The Modelling and simulation group at Ablynx, a Sanofi Company, is looking for an experienced pharmacometrician to join our team. The position is based in Ghent, Belgium.
Preferred Background: PhD in PK-PD or Pharmacometrics with Drug Development Experience.
Interested colleagues can apply via the link below https://sanofi.wd3.myworkdayjobs.com/SanofiCareers/job/Gent/ASSOCIATE-PRINCIPAL-SCIENTIST-M-F_R2525439-2
Ablynx, a Sanofi company, is engaged in the development of Nanobodies, proprietary therapeutic proteins based on single-domain antibody fragments, which combine the advantages of conventional antibody drugs with some of the features of small-molecule drugs. Ablynx advances a portfolio of Nanobody-based therapeutic programs in several major disease areas, including inflammation, haematology, immuno-oncology and oncology. www.ablynx.com This position requires substantial experience and expertise, as it will also entail mentoring and guidance of more junior PK/PD modelers and members of collaborating departments. At the project level, the individual will be a member of the translational medicine subteam and in specific cases may lead this subteam and participate on the project core team. The position is located in Belgium.
Responsibilities Main duties
- Participate in designing the early development plan and overall translational medicine and clinical pharmacology plan for the different steps of clinical development, according to the strategy developed by the Company.
- Serves as expert in PK/PD matters and modeling concepts and their application to dose selection, study design, risk/benefit, and informing drug development decisions in close collaboration with partners on projects.
- Integrates PK/PD results into regulatory filings and product labels.
- Interacts effectively with managers from various disciplines.
- Influences external environment through publications and presentations. Interactions
- Internal: Discovery, Safety & Toxicology Scientists, clinicians, project leaders, clinical trial managers, bioanalysis scientists, data managers, biostatisticians, representatives from Regulatory Affairs; internal governance bodies.
- External: PK/PD and pharmacometrics KOLs, academic research organizations, external technical and regulatory consultants, health authorities.
- Provides Modeling and Simulation support for the PK/PD characterization of the nanobody platform, to identify ADME factors to consider for optimal nanobody engineering.
Broad expertise is needed to cover project needs from the Discovery phase up to the final marketing application. - Has considerable organizational awareness (inter-relationship of departments, business priorities, etc.).
- Ensures cross-functional cooperation. Excellent communication skills and capacity to adjust the communication style to the audience.
- Ensures high quality documents, requiring strong writing and communication skills.
- Manages aggressive timelines effectively through cross-functional planning. Decision Making Authority
- Sees opportunities for supporting a streamlined and efficient drug development.
- Makes proposals and seeks endorsement for pharmacometrics strategies, is responsible for their execution, and communication to regulatory authorities.
- Advanced degree: M.Sc. or M.Sc./Ph.D with at least 5 years of research experience in industry and/or academia, with focus on clinical and/or translational research.
- Broad knowledge and understanding of pharmacological processes.
- Knowledge of clinical trials from early development to final submission phase.
- Knowledge and mindset in translational research and bridging strategies.
- Strong hands-on modeling and simulation skills (NonMem, R, PKSIM and/or other modelling and simulation softwares).
- Advanced mechanistic PK/PD modeling experience. Preferred Qualifications
- Postgraduate pharmacometrics and/or statistical training.
Contact email address: karley.yeoman@astrazeneca.com - 25th Nov 201 [2974]
At AstraZeneca we turn ideas into life changing medicines. Working here means being entrepreneurial, thinking big and working together to make the impossible into reality. We're focused on the potential of science to address the unmet needs of patients around the world. We commit to those areas where we believe we can change the course of medicine and bring new ideas to life.
As a Clinical/Senior Clinical Pharmacometrician, you will be responsible for population PK, PKPD, exposure-response, disease modelling, and simulations in all clinical development phases in oncology, with special emphasis on biologics . You will have the opportunity to contribute to state-of-the-art modelling and simulation (M&S) approaches. The desired candidate will have strong quantitative skills to influence designs and conduct decision-making at the project level.
Main duties and responsibilities:
- Accountable for expert data integration, analysis, interpretation, and reporting of M&S results within the project level
- Accountable for executing state-of-the-art M&S techniques with value for the project
- Use of M&S to influence study designs and decisions
- Scientific and strategic input into clinical, and post-approval development plans
- Support Biologic License Application in clinical pharmacology dossiers
- Development of mechanistic or empirical PKPD/tumor growth inhibition/time-to-event models to support projects for late-stage oncology assets
- Presentation of M&S results in internal and external forum
- Contribution to internal initiatives to develop the pharmacometric discipline
- Participation in and accountability for peer review of ongoing activities, reports and presentations
- Compliance with Good Clinical Practice (GCP) regulations as well as internal/external guidances
- Good knowledge of clinical pharmacology pathways involved in oncology, including the potential role of pharmacodynamic biomarkers to inform M&S approaches
- PhD degree preferred or equivalent (M.Sc./Pharm.D.)
- 3 years of drug development experience, with emphasis on pharmacometrics
- Expert knowledge of pharmacokinetics and Model-Based Drug Development
- Excellent skillset in written and verbal communication
- Demonstrated ability to identify, develop and execute M&S activities
- Knowledge of regulatory, compliance, processes, standards and issues in pharmacometrics
- Oncology disease domain knowledge
- Familiar with PK and statistical softwares such as NONMEM, R, Matlab, Winbugs, SAS, Monolix
- International reputation gained from publishing in pharmacometrics
External website https://astrazeneca.wd3.myworkdayjobs.com/en-US/Careers/job/UK---Cambridge/Clinical-Senior-Clinical--Pharmacometrician_R-065009-1
Contact email address: catia.marzolini@usb.ch - 22nd Nov 201 [2973]
PhD thesis in physiologically based pharmacokinetic modeling of long-acting injectable antiretroviral drugs: Basel, Switzerland
A fully funded PhD position (100%) is available in the Division of Infectious Diseases & Hospital Epidemiology at the University Hospital of Basel. The project aims to develop physiologically based pharmacokinetic (PBPK) models to simulate dosing requirements of long-acting intramuscular antiretroviral drugs in special populations and to manage drug-drug interactions with concurrent medications. The PBPK approach uses in vitro drug data (i.e. physicochemical characteristics, intrinsic clearance, and intestinal permeability) and a mathematical description of drug absorption, distribution, metabolism and elimination (ADME) to predict the pharmacokinetics in a virtual population. This research project is of particular clinical importance, as it will provide guidance on dosing requirements in special populations, which were not evaluated comprehensively during drug development but which may also benefit from this novel treatment paradigm aiming to improve the chances of life-long maintenance of HIV suppression. In addition, this project will provide a comprehensive knowledge of factors influencing intramuscular drug disposition and improve the knowledge on drug-drug interactions with this route of administration.
You are a highly motivated young scientist with an above-average degree (MSc or equivalent) in pharmacy, natural science or mathematics. In addition, you have knowledge about relevant pharmacological concept. Experience in modelling will be an advantage
This position is also open to candidates from the European Union and North America. The working language is English. German skills, although helpful, are not essential. Basel is a highly attractive city with a multinational population.
Application/contact Please send one PDF file including CV with academic transcripts, publications/ presentations at conferences, three academic references as well as a letter of motivation to: Prof. C. Marzolini: catia.marzolini@usb.ch and F. Stader: felix.stader@unibas.ch Applications will be considered until December 31, 2019. The position is available from April 2020.
Please note that there will be no follow-up correspondence for applications that do not fulfill the position requirements.