Vir Biotechnology is a commercial-stage immunology company focused on combining immunologic insights with cutting-edge technologies to treat and prevent serious infectious diseases. Vir has assembled four technology platforms that are designed to stimulate and enhance the immune system by exploiting critical observations of natural immune processes. Its current development pipeline consists of product candidates targeting COVID-19, hepatitis B virus, influenza A and human immunodeficiency virus.
We believe the success of our colleagues drives the success of our Mission. We have an ongoing commitment to creating a company passionate about equality, inclusion, and respect. When everyone feels supported and encouraged to give at their best, we will collectively deliver outstanding results.
Vir Biotechnology is seeking a Clinical Pharmacologist to support of all phases of drug development for from early clinical development, market application, and commercialization.
RESPONSIBILITIES AND LEARNING OPPORTUNITIES:
- You will be responsible for clinical PK and/or PK/PD study design, analysis, interpretation, operation, and reporting to support clinical development and international regulatory submissions (e.g., clinical protocols and reports, IB, IND, NDA/BLA).
- You will have broad responsibilities within the department designing and operationalizing studies, and analyzing data from clinical studies that evaluate the ADME, PK, and/or PK/PD of drug candidates.
- You will served as the clinical pharmacology technical expert on cross-functional project sub-team and/or project sub-teams.
- PhD. and 2-4 years of industry experience in Clinical Pharmacology
- Familiarity with the drug development process and the role of Clinical Pharmacology
- Experience in designing and facilitating operation and reporting of multiple Phase 1 studies and Phase 2/3 studies for dose selection/justification. Advanced analysis of demographic and disease characteristics (i.e., PopPK, PK/PD) is preferred
- Ability to translate preclinical data into clinical dosing schemes, including projection of PK in humans
- Experience independently developing or guiding development of PK and PK/PD models. Hands-on experience with Population PK modeling and/or PBPK, PK/PD modeling preferred.
- Must be operational on analysis and graphing software (e.g., SAS, R, Phoenix WNL, GraphPad, etc). #LI-Remote
Vir is an equal opportunity employer. We value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, sex, gender, gender expression, sexual orientation, age, marital status, veteran status, or disability status. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform critical job functions, and to receive other benefits and privileges of employment. Please contact Human Resources to request accommodation.
Vir Human Resources leads recruitment and employment for Vir. Unsolicited resumes sent to Vir from recruiters do not constitute any type of relationship between the recruiter and Vir and do not obligate Vir to pay fees should we hire from those resumes. We ask that external recruiters and/or agencies not contact or present candidates directly to our hiring manager or employees.
External website https://boards.greenhouse.io/virbiotechnologyinc/jobs/4133005005
Contact email address: firstname.lastname@example.org - 18th Nov 2022 
Contact: email@example.com - www.vesynta.com
Job title: Pharmacometrician / Pharmacokinetic Modeller
Location: The London Cancer Hub’s Innovation Gateway in South West London (Sutton).
Contract type: Full-time, permanent
About Vesynta: We are developing a toolkit that, for the first time, will enable clinicians dosing life-saving therapies (incl. chemotherapies, antibiotics and immunosuppressants) to map the unique pharmacokinetics of their patients at the point of-care using this information to rapidly identify the optimal dose, for each and every patient. Having spun-out of University College London, we work with clinicians, patients and academics across the UK, Europe and the USA, to establish this important healthcare innovation into clinical practice. Our work has been recognised and awarded for its vision and impact, including funding from prestigious grant competitions (Innovate UK, NIHR i4i) and private equity. We welcome you to join our journey to deliver data-guided dosing, that is safe, effective, and personalised to every patient.
Role description: You will operate within the clinical pharmacology division of the R&D team. It involves applied pharmacometrics including population pharmacokinetic (PK) and pharmacodynamic (PD) modelling building on exposure-response datasets. Your models form an integral part of our clinical software solution that will deliver personalised treatments in clinical practice. Support will be provided by senior team leads, internal clinical advisors and collaborators from globally renowned research institutions. This will aid your decision making and data interpretation, applied to real-world patients across a variety of disease areas. You will have the opportunity to lead pharmacometrics processes and techniques within the team, combined with strategic business exposure, to develop models for both product development and guide use-case prioritisation. You will work alongside our software developers to ensure your models are useable and scalable.
- Leading model development for paediatric oncology, adult oncology and antimicrobial clinical areas
- Work with data collected from clinical trials to derive plasma drug concentrations for application of precision dosing strategies
- Accountable for data integration, analysis, interpretation, and reporting of results via verbal and written communication to internal and external (peer-reviewed) audiences
- Collaborating with back-end and front-end software development team for model integration
- Use of models to influence go/no go decisions and support projects within new disease domains
- Contribute to internal initiatives to develop the pharmacometrics discipline including its processes
- Experience in population pharmacokinetic modelling or other complementary pharmacometric statistics
- Experience of using simulation software such as R, Python, NONMEM, etc
- Strong commitment to the study of clinical pharmacology and model-informed treatment personalisation
Point of contact: Dr Jugal Suthar
How to apply: Please email us your CV and motivations for applying to firstname.lastname@example.org, including the following reference: “VS-005344-HR” to begin the conversation.
Closing date: 09 January 2023
Links to full posting:
External website https://www.linkedin.com/jobs/view/3344983807
Contact email address: email@example.com - 13th Nov 2022 
At the University of Bonn, Germany, we have an open postdoctoral research position in Pharmacometrics for 3 years.
The position is part of a cooperation of our Department of Clinical Pharmacy with the Federal Institute for Drugs and Medical Devices (BfArM) in Bonn which is the national authority for the approval and safety of drugs in Germany. Therefore, this position is particularly attractive for pharmacometricians with interest in academia and regulatory affairs. It offers career opportunities in both directions.
The postdoctoral position requires a doctoral (Ph.D. or equivalent) degree in pharmacometrics. German knowledge is not required.
Please find further information on the position under the following link: https://www.uni-bonn.de/de/universitaet/medien-universitaet/medien-arbeiten-an-der-uni/medien-personalmanagement/pdfs-stellenausschreibungen-wiss.ma/37-22-331_en.pdf
Prof. Dr. Ulrich Jaehde Institute of Pharmacy University of Bonn An der Immenburg 4 D-53121 Bonn
Tel.: +49-228-735252 Fax: +49-228-739757 E-Mail: firstname.lastname@example.org
External website https://www.klinische-pharmazie.info
Contact email address: email@example.com - 27th Oct 2022 
Postdoctoral Fellow and Ph.D. students Opportunity One Postdoctoral position is available at the group of Dr. Zhu Zhou at York College of the City University of New York (CUNY) and The CUNY Graduate Center to work on the research project funded by NIH. The postdoctoral fellow will conduct research that supports understanding of pharmacokinetics and pharmacodynamics in special/disease populations and enables precision dosing. The postdoctoral fellow will be initially appointed for a year-long term. The position is renewable for another year with the possibility of an extension, with an anticipated start date of Feb 2022 (negotiable). The candidate should be highly motivated and able to work well independently and have excellent communication skills. The ideal candidate should have a strong interest in model-informed precision dosing, pharmacometrics approaches to optimize pharmacotherapy. Applicants in related fields are encouraged to apply.
Duties and responsibilities:
- Conduct research that supports understanding of pharmacokinetics and pharmacodynamics in special/disease populations and enables precision dosing. Model design and simulation of pharmacokinetics and pharmacodynamics data
- Publish high-quality primary research articles in peer-reviewed journals and prepare grant proposals.
- Apart from the projects, the fellow will have the opportunity to develop his or her teaching skills, help with mentoring new graduate students
- Adheres to standards for safety and hygiene and ethical conduct as defined by the University and relevant outside parties
- Doctorate (PhD, PharmD, MD, or DVM) in pharmaceutical sciences, pharmacokinetics, pharmacology, pharmacodynamics, or relevant field.
- Good track record of productive research and publications.
- Demonstrated proficiency in written and oral communication skills.
- Excellent organizational and interpersonal skills.
- Ability to work independently on assigned projects.
- Experience with pharmacokinetics/pharmacodynamics modeling and simulation and related software packages
- Experience with pre-clinical and clinical studies
Dr. Zhou's lab also has 1-2 Ph.D. student positions. This is open to candidates with a university degree in pharmacy, pharmaceutical sciences, biochemistry, biostatistics, bioinformatics, life sciences, or medicine. See https://www.gc.cuny.edu/admissions-aid/how-apply for how to apply for the Ph.D. program.
Interested candidates can submit a cover letter, CV, as well as names and contact information of three references to Dr. Zhou by email: firstname.lastname@example.org
Contact email address: email@example.com - 19th Oct 2022 
JOB PURPOSEMMV is a Swiss non-profit foundation whose mission is to reduce the burden of malaria in disease-endemic countries by discovering, developing and delivering new, effective and affordable antimalarial drugs. Working with drug discovery/development partners in academia and industry, as well as with country-based delivery partners and national ministries of health/malaria control programmes, MMV’s focus extends from the identification of new potential treatments for malaria through to clinical development, regulatory approval and delivery-for-impact in malaria-endemic countries. Since its founding in 1999, MMV and partners have brought forward 11 new medicines that have saved an estimated 2.7 million lives.
We are currently seeking a PKPD postdoc to join our Pharmacometrics team. We are seeking a highly motivated individual who will provide scientific expertise in PKPD modelling as well as modelling and simulation strategy.
PRIMARY DUTIES AND RESPONSIBILITIES:
- Develop innovative models to help the integration of new data and/or new experiments
- Provide PBPK and/or PKPD modeling expertise to preclinical and clinical projects to help speed-up the development of molecules for antimalarial treatment or chemoprevention
- Develop and apply modelling solutions for monotherapy and combination therapy
- 20% of time will be allocated to a specific research project, supporting MMV’s strategy, to develop an innovative PKPD modeling approach
- Author and publish high-quality research articles
- Attend selected conferences for training, giving presentations and posters, representing MMV, and building a network
EDUCATION AND EXPERIENCE:
START DATE: As soon as possible
DEADLINE: November 16, 2022
MORE INFORMATION AND APPLICATION: on https://www.mmv.org/about-us/work-us/jobs#op-526029-pharmacometrics-scientist - MMV website
Contact email address: firstname.lastname@example.org - 17th Oct 2022 
Working at Horizon is more than a job – it’s personal. For us, success is measured by the numbers that matter most – the number of lives we touch, the number we change and those we work tirelessly to help save. We’re a team of agile, out-of-the-box thinkers who are inspired to do more because we know we’re a part of something bigger. We strive to build meaningful careers at a company whose values we share because when we live up to our potential, we help others live up to theirs.
- Support clinical pharmacology function for clinical development of both small and large molecules and act as clinical pharmacology subject matter expert on multidisciplinary teams.
- Responsible for study design and data interpretation of clinical pharmacology studies, including pharmacokinetics, pharmacodynamics, food effect, relative bioavailability, drug-drug interaction, QTc, and special population studies.
- Conduct non-compartmental and population PK, PK/PD, and exposure-response analysis to support key program decision-making (eg, phase 2/3 dose selection).
- Author clinical and regulatory documents related to clinical pharmacology components, including protocols, investigator brochures, study reports, briefing documents for regulatory meetings, and NDA/BLA; author scientific publications.
- Represent clinical pharmacology in regulatory interactions (eg, pre-IND, EOP2, pre-NDA/BLA). Present scientific results to internal and external stakeholders.
- Collaborate with toxicologist and preclinical pharmacology scientists to design, conduct, and report preclinical PK and translational PK/PD studies to support candidate selection and IND filing, including human PK prediction to support starting dose and dose escalation schemes for first-in-man studies.
- Provide oversight and work closely with collaborators and CROs in study protocol/report review for both preclinical and clinical studies.
- PhD or equivalent experience in Pharmacokinetics, Pharmacometrics, Pharmaceutical Sciences, or other related disciplines.
- 5 years of industry or equivalent experience in PKPD, clinical pharmacology, and/or pharmacometrics (DMPK experience is a plus).
- Proficiency in mathematical modeling and programming as demonstrated by hands-on experience in computational tools (e.g. R, NONMEM)
- Demonstrated ability to work in a highly collaborative, multi-disciplinary team setting.
- Excellent verbal and written communication skills.
- Self-directed and highly-motivated researcher, with willingness to learn new tools and approaches.
- Professional, proactive demeanor.
Contact email address: email@example.com - 27th Sep 2022 
Modelling scientist/specialist/principal scientist
Do you wish to be a part of our modelling team focusing on pharmacokinetics (PK) and pharmacodynamics (PD) from clinical studies? Can you help us in guiding decisions in clinical drug development using clinical trial simulations? If so, then you could be a part of our growing area!
We are hiring for several positions within the Pharmacometrics department at Novo Nordisk. Several locations are available across the globe (Copenhagen, Madrid, Boston, etc).
Novo Nordisk has a clear purpose of driving change to defeat diabetes and other serious chronic diseases. To support this, a new Data science organisation has been established in which Pharmacometrics is anchored. Our vision is to ensure Novo Nordisk is a global healthcare leader powered by data, analytics, and digital technologies. We are therefore looking for strong modelling scientists to help us reach our goals.
Deadline for applications: 16 October 2022
Please note, that screening and interview will be done on an ongoing basis.
Contact email address: firstname.lastname@example.org - 26th Sep 2022 
Vir is a science-driven company guided by medical need. Vir integrates diverse innovations in science, technology, and medicine to transform the care of people with serious infectious diseases. Vir is taking a multi-program, multi-platform approach to applying these breakthroughs, including the development of treatments that induce protective and therapeutic immune responses. Vir’s scale and scope together with leading scientific and management expertise, allow it to perform significant internal R&D, in license or acquire innovative technology platforms and assets, and fund targeted academic research.
Primary job includes uploading data from in vitro and in vivo DMPK studies, tracking outsourced assays, assisting in lab supply management and ordering. High throughput assay experience a plus. You will work within a highly collaborative group focused on infectious disease research. Candidates should have experience working in a laboratory research setting.
- With guidance from our Scientists, process in vitro DMPK data and upload to internal database
- Tracking outsourced studies
- Maintaining stock of laboratory supplies
- Potential for assisting in high throughput assay conduct
- Maintain a high level of scientific integrity and laboratory safety
- Demonstrate good verbal and written communication and interpersonal skills
- Experience working in a biology or chemistry laboratory setting
- Strong communication skills, and ability to work with inter-disciplinary and cross-functional teams.
- Desire and demonstrated ability to quickly develop new technical skills
- Proficiency in Microsoft Office applications is required.
- BS/MS in chemistry, biology, or related field
The Human Resources team manages the recruitment and employment process for Vir. Unsolicited resumes sent to Vir from recruiters do not constitute any type of relationship between the recruiter and Vir and do not obligate Vir to pay fees should we hire from those resumes. Recruiters are requested not to contact or present candidates directly to our hiring manager or employees.
External website https://boards.greenhouse.io/virbiotechnologyinc/jobs/4089881005
Contact email address: email@example.com - 7th Sep 2022 
CALL FOR APPLICATIONS within the interdisciplinary PhD program PharMetrX
The Graduate Research Training Program PharMetrX: Pharmacometrics & Computational Disease Modelling is an interdisciplinary PhD program bridging pharmacy and mathematics. It aims at understanding the drug-patient-disease interaction by analysing data of drug concentration, effect & disease profiles of pre-/clinical trials and of therapeutic care by developing and using mathematical & statistical models.
We are currently inviting applications to enrol in the PharMetrX Research+ Program or the PharMetrX Training+ Program.
The PharMetrX Research+ Program (Research & Training & Network) comprises an excellent research environment in the vibrant Berlin/Potsdam area, fascinating and innovative research projects in a highly relevant field, truly transdisciplinary supervision, an individual mentorship from one of the associated industry partners, a specifically tailored training program of compact modules, a network of peers and a highly competitive 3.5 years fellowship.
The PharMetrX Training+ Program (Training & Network) offers a specifically tailored training program of compact modules that convey the foundations in pharmacokinetics & pharmacodynamics, systems biology, statistics, methodological approaches of modelling & simulation etc. as well as a network of peers. It is open for PhD students who have already started their PhD in the field of pharmacometrics or will do so soon.
Both programs are open to candidates with a university degree in pharmacy, pharmaceutical sciences, mathematics/statistics, bioinformatics, life sciences or medicine. See https://www.PharMetrX.de for further details.
Deadline for applications: 15 September 2022.
PharMetrX is a joint program of Freie Universität Berlin and the University of Potsdam, supported by a consortium of global research-driven pharmaceutical companies.
Charlotte Kloft & Wilhelm Huisinga Program Chairs
External website https://www.PharMetrX.de/
Contact email address: firstname.lastname@example.org - 1st Sep 2022 
Executive Director Search!
Lead a current group and continue to build this group as this well known company continues to grow.
Our Client is looking for an Executive Director (Head) to lead the Pharmacometrics/Quantitative Pharmacology (QP) function. This person provides strategic leadership, subject matter expertise, direction and hands on support for the activities of this function. This role has overall accountability for the delivery of modeling and simulation (M&S) activity across the development continuum and will provide a vision for the strategic direction of the team.
Continued development and management of the QP function within the organization to support portfolio across all Therapeutic Areas Mentor and develop the QP team.
Ultimately accountable for the strategy, execution and delivery of population PK and PK/PD modeling in support of dose-selection from FIH through phase 3. The clear description of these quantitative pharmacology activities in study reports and regulatory summary documents is also in scope.
Responsible for development and implementation of Quantitative Pharmacology strategy to support research, early to late stage clinical development, and global regulatory submissions.
Stimulate innovation, exploring new quantitative pharmacology methodologies to support drug development programs.
Integrate innovative M&S strategies, with innovative quantitative methods and a variety of unique response variables to develop novel and informative PK/PD models in the advancement of drug candidates.
Partner with Clinical Pharmacology, PreClinical PK/PD and other functions within Drug Safety and Pharmacometrics to optimize the R& pD portfolio.
Foster and maintain effective and positive collaborations across the organization including Clinical Sciences, Early Clinical Development, Predictive Medicine, Statistics and Database Management.
In order to be considered for this role, you must: We additionally expect 15+ year proven experience in population PK, PK/PD M&S, and quantitative pharmacology in the pharmaceutical industry.
Please let me know if you’d like to learn more about this role, the hiring manager and company.
External website https://www.stem-sourcing.com
Contact email address: email@example.com - 16th Aug 2022 
For our Translational Medicine organization, and our Clinical Pharmacology & Pharmacometrics Unit based at our Headquarters in Lausanne, we are looking for a
Principal Clinical Pharmacologist
You will be the leader for developing the clinical pharmacology and pharmacometrics scientific strategy for assigned projects in Oncology and Antibiotics. To that aim, you will manage, conduct and supervise clinical pharmacology and pharmacometrics activities to add value, support, and accelerate the development of Debiopharm’s innovative medicine. In Project Teams, you will also represent the Clinical Pharmacology & Drug Metabolism function
Your responsibilities will be but not limited to:
Work in close collaboration with the project team and develop the clinical pharmacology scientific strategy for assigned projects in Oncology or Antibiotics Manage the clinical pharmacology activities of assigned projects, by contributing to the design of clinical pharmacology studies (SAD/MAD PK, bioequivalence, food effect, drug-drug interactions, PK in special populations, …), planning and managing the pharmacometrics activities Be a member of the Clinical Study team, contribute to the protocol writing and manage the PK and PK/PD analyses (noncompartmental analyses and modeling approaches) and reporting; manage the risk of food-drug interactions and drug-drug interactions with regard to concomitant medications. Manage the outsourced activities, from provider selection until completion of project Contribute and participate to scientific communication and events Prepare the clinical pharmacology and pharmacometrics documentation to support regulatory or other cross-functional activities; may participate in interactions with Health Authorities As part of Debiopharm’s model, contribute to the In & Out licensing activities or external fund-raising activities
PhD (PharmD is a plus) in Lifesciences, pharmacokinetics, clinical pharmacology, or a related discipline At least 7-year experience in clinical pharmacology within Translational R&D and early clinical phases in drug development Expertise in Pharmacometrics such as Non-Compartmental PK analysis, Population PK/PD, Modeling & Simulation Excellence knowledge of GCP, GCLP, GLP, and relevant regulatory guidelines Experience in Oncology is an asset You are used in working in cross-functional team and fast-paced environment Team player, looking to tackle challenges together with your team Excellent communication skills in English (oral and written), French is an asset
External website https://apply.workable.com/j/F162A69551
Contact email address: firstname.lastname@example.org - 10th Aug 2022 
AD/Director Pharmacometrics--please reach me if interested at email@example.com
This is not your average pharmacometrics role. Title will be commensurate with experience. My client is a biotech company of 500+ people with $1.2 billion cash on hand. Working in multiple therapeutic areas with 3 major modalities. Partnerships include impressive major pharma and academic institutions. Very interesting science and opportunity to get in and be one of the first hires in the dept. Take a look and let me know if interested and either want to discuss or have a referral. Ideally hybrid, so some onsite time in MA.
Associate Director/Director position that will support a rapidly expanding clinical portfolio of promising therapeutics. The candidate in this position should have strong technical skills and be well versed in PK and PD with strong ability to critically evaluate and interpret data, conduct NCA, and PKPD modeling.
- Serve as key functional expert to lead, direct, and coordinate the activities of a specific assigned modeling project.
- Develop, write, and execute pharmacometrics analysis plans, and deliver reports on results as well as define and drive pharmacometrics contributions to regulatory/submission strategy and related documents.
- Provide strategic expertise and leadership for development programs based on relevant technical and disease area knowledge.
- In collaboration with cross functional partners, provide support for the quantitative evaluation of competing trial/analysis strategies.
- Mentor others to develop scientific, technical, and leadership skills.
- Preparation of abstracts and manuscripts for publications. Qualifications:
- Ph.D. in Pharmacokinetics, Pharmacology, Pharmaceutics or other relevant field with 4-10 years experience in pharmaceutical industry
- Expert knowledge and evidence of hands-on experience in the application of pharmacometrics methods to drug development.
- Expertise in pharmacokinetics, PKPD principles, ADME concepts, and clinical pharmacology.
- Expertise in Phoenix WinNonlin, R, NONMEM, or other pharmacokinetic, modeling and data visualizations software.
- Strong communication skills (verbal and written) and presentation skills are required.
Contact email address: firstname.lastname@example.org - 2nd Aug 2022 
Our client is the world's fastest growing biotech and pharma company with over 1000 hires last year. They are seeking a Quantitative Pharmacology Director or Sr. Dir. This exceptional scientist:
Possesses a deep understanding of scientific literature and technical skills in a number of PK/PD methods and techniques. Has extensive knowledge base of the work in overall scientific community in own discipline.
Is recognized as an expert in own area within the organization. Has extensive regulatory experience through authoring of regulatory briefing books, CTD summaries, contribution at HA meetings, HA negotiations through regulatory reviews and approvals of BLA or equivalent.
Please message me to learn more email@example.com
External website https://www.stem-sourcing.com
5th Jul 2022 
The Department of Discovery Drug Metabolism and Pharmacokinetics in Evotec Verona is looking for an enthusiastic and dedicated Scientist with a track record within the field pharmacokinetics and PKPD M&S to support the characterisation, profiling and selection of drug candidate molecules for different modalities (i.e. Small molecule, RNA targeting and Therapeutic mAb). The candidate will be expected to spend most of his/her time in M&S of PK and PKPD data and to prepare and deliver written and oral work summaries to project teams and clients. Project teams at Evotec are interdisciplinary and require strong team players with effective communication and strong flexibility. Significant components of the role include technical leadership/ownership.
Your Job And Key Responsibilities
Provide PK, PKPD and PBPK modelling expertise to drug discovery projects using industry standard software (i.e. WinNonlin/Phoenix, NONMEM, PK-Sim and GastroPlus) As DMPK project representative, or in conjunction with DMPK project representatives, plan, design and report PK and PKPD studies supporting drug discovery projects for multiple modalities (i.e. Small molecule, RNA targeting and Therapeutic mAb) Work closely and effectively with drug discovery partners, particularly chemistry, biology, safety/toxicology and formulation teams Maintain high level of quality and reliability
Our preferred candidate has the following personal and professional qualifications: Relevant scientific degree or PhD Minimum of 2 years’ industrial experience supporting research/preclinical projects Awareness and understanding of the role of DMPK in Research & Development Solid hands-on experience within M&S of translational PK and PKPD data Solid hands-on experience within PBPK simulation including human PK prediction Efficient, goal oriented and independent work style with flexible mind-set Team player with strong collaboration and communication skills Able to build strong relationships both internally and externally, with colleagues, suppliers and clients Fluent in oral and written English
PLEASE APPLY NOW!
29th Jun 2022 
POST DOCTORAL RESEARCH ASSOCIATE (PDRA) in PHARMACOKINETIC/ MATHEMATICAL MODELLING Pharmacology & Therapeutics
Closing: 12-Jul-2022 23:30
We are seeking an experienced individual to work as a PDRA in PK/PD modelling for a National Institutes of Health (NIH) (USA) funded project. The role will provide support within the Modelling and Simulation Core service as part of the Long-Acting/Extended Release Antiretroviral Resource Program (LEAP). You will work under the direction of Professor Andrew Owen and other delegates within the team. You will join a multi-disciplinary team of pharmacologists and chemists working on research into the development of the next generation of long-acting candidate medicines. You should have a PhD in Pharmacology or related discipline and expertise in mathematical modelling.
The post is available from 1st July until 31st December 2022 initially with a view to further extension.
The University has the right to close the vacancy early if it is deemed that there have been enough applications received
External website https://my.corehr.com/pls/ulivrecruit/erq_jobspec_version_4.display_form?p_company=1&p_internal_external=E&p_display_in_irish=N&p_process_type=&p_applicant_no=&p_form_profile_detail=&p_display_apply_ind=Y&p_refresh_search=Y&p_recruitment_id=044047
Contact email address: firstname.lastname@example.org - 3rd Jun 2022 
Our Client is a biopharmaceutical company developing a new generation of oral integrin therapies for the treatment of serious chronic diseases, including autoimmune, cardiovascular and metabolic diseases, fibrosis and cancer. In collaboration with AbbVie, Janssen and Schrödinger, Our Client is advancing its pipeline and discovery activities using its proprietary technology platform which leverages the Company’s unique understanding of integrin structure and biology.
Our Client is advancing both partnered and fully-owned oral integrin therapeutic candidates with the initial clinical trials beginning in the 2020. Our immediate focus is on the areas where the clinical activity of antibody inhibitors of integrins is precedented, thus enabling a rapid path to clinical proof-of-concept. Our Client Therapeutic is located in Waltham, MA. We are seeking a highly talented and motivated individual to join our culture of teamwork, craftsmanship, tenacity, compassion, and integrity.
The successful candidate will have the opportunity to use quantitative methodologies to shape the overall clinical development plan for Our Client drug candidates. The position will be part of a multi-disciplinary drug development team working together towards transformative small molecule therapeutics for autoimmune and fibrotic diseases. In-depth experience in quantitative PK and PD data analysis is required.
- Contribute to the planning, trial design and data analysis for clinical studies including SAD/MAD, drug-drug interaction, biopharmaceutics, special population studies, human ADME, and thorough QT studies
- Perform clinical and non-clinical PK and PK/PD analysis and communicate analysis outcomes to internal and external stakeholders.
- Assess and integrate knowledge of PK, PD, safety, and patient characteristics to design dosing regimens; Participate in the preparation of clinical study protocols and data analysis plans
- Oversee and liaise with CROs for population based pharmacokinetic/pharmacodynamic data analysis; Draft and/or review clinical PK reports and incorporate PK/PD sections into clinical study reports and relevant CTD components for regulatory submissions
- Interface with nonclinical and clinical development colleagues such as clinical sciences and regulatory, and provide expert input in interactions with and responses to regulatory agencies
- 7+ years’ experience and a PhD or PharmD degree with emphasis in pharmacokinetics, clinical pharmacology, or a related scientific discipline
- In-depth knowledge of pharmacokinetic (WinNonlin) and working knowledge of population based PK/PD analysis software such as NONMEM, Monolix, R, or other modeling platforms
- Excellent written and oral communication skills and ability to convey complex technical information clearly to the team; Proven track record of working effectively in a dynamic, collaborative, team-oriented setting
- Understanding of PKPD, drug metabolism, and clinical research concepts and experience analyzing clinical dose-response and PKPD data; Knowledge of current regulatory guidance related to clinical pharmacology
External website https://www.stem-sourcing.com