Director, Pharmacometrics (Remote) Clinical Pharmacology group
Job Description
The Director of Pharmacometrics will be part of the Clinical Pharmacology group and drive quantitative clinical pharmacology strategy across all clinical and preclinical programs in oncology. The Director-PMX will be expected to drive the impact of quantitative PK/PD modeling and simulation to inform dose selection, dose optimization and dosing schedule for clinical studies as well as author regulatory documents.
Summary of Key Responsibilities
- Enable and drive development of population PK, PK/PD, exposure-response models to support clinical programs
- Effectively collaborate with clinical pharmacology, Biostatistics, Data Sciences and clinical development to develop analysis plans and contributes per timelines.
- Manage pharmacometrics resources including consultants to meet priorities of the clinical project teams
- Champion model-based drug development through their work across the organization.
- Experience in developing quantitative strategies for impacting clinical decisions
- Demonstrated ability to effectively participate in an interdisciplinary team, and to oversee the work of other scientists
- Independently analyzes, interprets, and reports PK/PD modeling results for internal decision making and regulatory filings.
Prepare responses to regulatory health authority inquiries on PK, PK/PD related issues.
- Ph.D. in Pharmaceutical Sciences / Pharmacometrics or related quantitative fields or equivalent degree with ≥ 10 years of experience; OR a PharmD or equivalent degree with ≥ 12 years of experience, OR an MS or equivalent degree with ≥ 15 years of experience
- Expertise in pharmacometrics (e.g., population PK and PK/PD analyses, dose response and exposure-response analyses, preclinical PK/PD and dose projections for clinical studies)
- Experience with modeling of oncology endpoints (preclinical and clinical) is a plus;
- Experience with regulatory interactions (e.g., responding and resolution to regulatory queries) including filing is a plus.
- Passionate about science and driven by scientific curiosity
- Open minded, receptive to input and a strong team player
- Self-driven, able to multi-task and manage time-sensitive workloads
- Problem solver with ability to transform complex tasks into actionable deliverables
- Strong interpersonal skills with ability to work in matrix environment
- Strong written and oral communication skills Communication Skills: demonstrates ability to effectively present complex data to various audiences in both verbal and written form.
External website https://www.stem-sourcing.com
Contact email address: telder@stem-sourcing.com - 3rd Jan 2022 [3084]
Director/Sr. Director Clinical Pharmacology
Our Client is currently seeking a Clinical Pharmacology leader. Reporting to the SVP Early Development, the incumbent will be the clinical pharmacology representative on project teams developing small molecule modulators as precision cancer medicines. We are looking for a consummate team player seeking a collaborative environment in which to grow their career in drug development. Responsibilities In partnership with functional/project leaders, set the clinical pharmacology strategy and plans for Company's programs in clinical development. Be the functional area representative for clinical pharmacology on project teams.
Lead the planning, design, conduct and analysis of standalone clinical pharmacology studies in collaboration with internal cross-functional team. Work closely with DMPK in the design and integration of clinical PK/PD activities, collaborate with Clinical Operations in the planning and conduct of clinical PK studies.
Oversees activities including non-compartmental PK analysis, population PK, PK/PD, physiologically-based, and other modeling and simulation (M&S) approaches. Coordinates with internal and external team in the data review, analysis and reporting of clinical pharmacology sections of CSRs including PK and pharmacometrics analyses.
Author and review clinical protocols, study reports and prepare relevant sections of regulatory documents, including INDs, clinical trial applications (CTAs), Investigator Brochures, regulatory Briefing Documents and NDAs/MAAs.
Qualifications An advanced degree and years of experience in the biotech/pharmaceutical industry, with a focus in clinical pharmacology, pharmacokinetics, pharmacometrics or related discipline.
Previous experience in managing clinical pharmacology programs, and in the design, execution, and regulatory reporting of clinical PK/PD studies is required.
Technical depth in clinical pharmacokinetics, PK/PD analysis, and M&S approaches, preferably with experience in oncology. Experience applying M&S through development a plus.
Experience conducting clinical pharmacology programs through early and late-stage development.
Operational experience and familiarity with the drug discovery and development process, including external regulatory requirements. Well versed in authoring and reviewing relevant sections of regulatory dossiers.
Proficient in the management of activities at contract research organizations and comfortable working in virtual outsourced model.
External website https://www.stem-sourcing.com
Contact email address: gobeaun@mmv.org - 17th Dec 2021 [3083]
JOB PURPOSE
Medicines for Malaria Venture (MMV) is a Swiss non-profit foundation whose mission is to reduce the burden of malaria in disease-endemic countries by discovering, developing and delivering new, effective and affordable antimalarial drugs. Working with drug discovery/development partners in academia and industry, as well as with country-based delivery partners and national ministries of health/malaria control programmes, MMV’s focus extends from the identification of new potential treatments for malaria through to clinical development, regulatory approval and delivery-for-impact in malaria-endemic countries. Since its founding in 1999, MMV and partners have brought forward 11 new medicines that have saved an estimated 2.7 million lives.We are currently seeking a Manager, PKPD Modelling and Simulation to join our Pharmacometrics team. This is a permanent position based in Geneva, Switzerland (partially remote: currently Covid-remote).
PRIMARY DUTIES AND RESPONSIBILITIES:
- Develop innovative models to help the integration of new data and/or new experiments
- Develop PKPD modelling strategy for MMV projects in late discovery and development, undertake and supervise the delivery of the PKPD modelling across MMV’s therapeutic indications
- Develop and apply modelling solutions for monotherapy and combination therapy
- Summarize, interpret and clarify PKPD results to ensure that valuable scientific information is provided in a timely manner to drive team decisions
- Communicate PKPD modelling strategy and results to project teams, MMV management and regulators
- Contribute to establishing pharmacometrics capabilities and infrastructure (eg development of tools for recurrent and consistent analysis, development and implementation of guidance documents and SOPs within the Pharmacometrics Team)
- Provide pharmacometrics components for submission to regulatory authorities
- Supervise the work of PKPD consultants and academic partners
- Author and publish high-quality research articles
- Attend selected conferences for training, giving presentations and posters, representing MMV, and building a network
EDUCATION AND EXPERIENCE:
- Ph.D. in Biomedical Science, Pharmacy, Clinical Pharmacology, Biometrics or Computational Engineering
- At least 3 years of experience (academia and/or industry) with a proven track record within the duties mentioned above
- Published peer-reviewed articles
- Familiarity with the drug development process
- Experience working in a cross-functional matrix
START DATE: As soon as possible
DEADLINE: January 3rd, 2022
MORE INFORMATION AND APPLICATION: on https://www.mmv.org/about-us/work-us/jobs#op-485324-pkpd-modelling-manager the MMV website.
External website https://www.mmv.org/about-us/work-us/jobs#op-485324-pkpd-modelling-manager
7th Dec 2021 [3082]
Postdoctoral Fellowship in Physiologically Based Pharmacokinetic Modeling
Karmanos Cancer Institute, Wayne State University School of Medicine
A postdoctoral research associate position is available at Karmanos Cancer Institute, Wayne State University to work on projects focused on the development and application of physiologically-based pharmacokinetic (PBPK) models for predicting heterogeneous drug penetration and distribution in the human brain and brain tumors. The projects will involve in vitro studies (to determine metabolic and transporter kinetics, and drug binding to plasma proteins and tissues) and PBPK model development and application.
Requirements:
- The successful candidate will have minimum of a PharmD or PhD degree in pharmaceutical Sciences, pharmacology, or other related discipline with some understanding of pharmacokinetic/pharmacodynamic analyses.
- Experience with computational modeling using MATLAB, R language is preferred.
- Excellent communication skills and the ability to work independently and as a member of an interdisciplinary team are essential.
Contact email address: telder@stem-sourcing.com - 1st Dec 2021 [3081]
Director/Sr. Director Clinical Pharmacology
Our Client is currently seeking a Clinical Pharmacology leader. Reporting to the SVP Early Development, the incumbent will be the clinical pharmacology representative on project teams developing small molecule modulators as precision cancer medicines. We are looking for a consummate team player seeking a collaborative environment in which to grow their career in drug development. Responsibilities In partnership with functional/project leaders, set the clinical pharmacology strategy and plans for Company's programs in clinical development. Be the functional area representative for clinical pharmacology on project teams.
Lead the planning, design, conduct and analysis of standalone clinical pharmacology studies in collaboration with internal cross-functional team. Work closely with DMPK in the design and integration of clinical PK/PD activities, collaborate with Clinical Operations in the planning and conduct of clinical PK studies.
Oversees activities including non-compartmental PK analysis, population PK, PK/PD, physiologically-based, and other modeling and simulation (M&S) approaches. Coordinates with internal and external team in the data review, analysis and reporting of clinical pharmacology sections of CSRs including PK and pharmacometrics analyses.
Author and review clinical protocols, study reports and prepare relevant sections of regulatory documents, including INDs, clinical trial applications (CTAs), Investigator Brochures, regulatory Briefing Documents and NDAs/MAAs.
Qualifications
An advanced degree and years of experience in the biotech/pharmaceutical industry, with a focus in clinical pharmacology, pharmacokinetics, pharmacometrics or related discipline.
Previous experience in managing clinical pharmacology programs, and in the design, execution, and regulatory reporting of clinical PK/PD studies is required.
Technical depth in clinical pharmacokinetics, PK/PD analysis, and M&S approaches, preferably with experience in oncology. Experience applying M&S through development a plus.
Experience conducting clinical pharmacology programs through early and late-stage development.
Operational experience and familiarity with the drug discovery and development process, including external regulatory requirements. Well versed in authoring and reviewing relevant sections of regulatory dossiers.
Proficient in the management of activities at contract research organizations and comfortable working in virtual outsourced model.
External website https://www.stem-sourcing.com
Contact email address: helen@scismic.com - 24th Nov 2021 [3080]
Scismic is supporting the growth of a biotech company that is developing organ-on-a-chip technology.
We are seeking a highly motivated Scientist, a PBPK Modeler to develop in vitro-in vivo extrapolation (IVIVE) methods for bioengineered, multi-organ microphysiological systems (MPSs (e.g., liver, gut, BBB, brain)). The role will involve developing human physiologically-based pharmacokinetic (PBPK) models constrained by the in vitro MPS data and in vivo clinical data. Experience with drug-drug interaction (DDI) and transporter-dependent ADME is preferred. The PBPK Modeler will extend existing models and implement new models; collaborate with other computational modelers on parameter estimation and model integration; and participate in cross-functional teams that include biomimetic engineers and experimental biologists conducting the MPS experiments.
Qualifications
- MS or PhD with some industry experience.
- Demonstrated expertise in IVIVE and PBPK methods.
- Technical skills in programming (e.g., Python, MATLAB, R) and presentation (e.g., PowerPoint) are required; experience with GitHub is preferred.
The following are desirable:
- Industry experience with small molecule pharmacokinetics (DMPK)
- Industry or academic experience with modeling drug-drug-interaction (DDI) and/or transporter-dependent ADME processes
- Understanding of ADME processes in liver, gut, BBB, and brain
- Experience with relevant databases (e.g., UW DIDB, DrugBank, ChEMBL)
- Experience with QSP, PK/PD, or pop PK modeling
- Able to work well under direction; self-motivated and able to work as a team in a multidisciplinary, fast-paced, dynamic, and results-oriented environment.
Responsibilities
- Development and application of IVIVE methods for DMPK-on-a-chip (e.g., analysis of in vitro MPS data and scaling of in vitro ADME parameters)
- PBPK model development, calibration, and validation to predict human drug distribution and clearance
- Parameterization of PBPK models using IVIVE with MPS data
- Model-guided prediction of human ADME properties and DDI
- Curation of data needed to support IVIVE and PBPK modeling (e.g., clinical data, parameter values, etc)
- Collaborate with other computational modelers on model integration
- Participate in cross-functional teams and client meetings that include occasional presentations to experimentalists
- Contribute to planning the larger modeling strategies and model-guided suggestions for experimental design
External website https://scismic.com/jobs/pbpk-modeler
Contact email address: gguglielmi@jouncetx.com - 16th Nov 2021 [3074]
Scientist/Senior Scientist, Pharmacometric Modeling and Clinical Pharmacology
Role / Responsibilities The Clinical Pharmacology Team at Jounce Therapeutics is hiring! We are seeking a motivated early-career pharmacometrician for a hands-on role performing PK and pharmacometrics analyses to support the development of novel immuno-oncology biological therapeutics. The successful candidate will support projects from discovery through clinical development with quantitative analyses to support candidate selection/optimization and selection of the first-in-human dosing range and recommended phase 2 dose, and conduct exposure/response analyses to support internal decision-making and BLA filings. The incumbent will also have the opportunity to represent clinical pharmacology in project team and sub team meetings and participate in meetings with senior management and regulatory authorities as part of a growing function at Jounce. Please see the linkedin Job Description for further details on responsibilities and qualifications.
Company Summary
Jounce Therapeutics, Inc. is a clinical-stage immunotherapy company dedicated to transforming the treatment of cancer by developing therapies that enable the immune system to attack tumors and provide long-lasting benefits to patients through a biomarker-driven approach. Jounce currently has multiple development stage programs ongoing while simultaneously advancing additional early-stage assets from its robust discovery engine based on its Translational Science Platform. Jounce’s highest priority program, JTX-8064, is a LILRB2 (ILT4) receptor antagonist shown to reprogram immune-suppressive tumor associated macrophages to an anti-tumor state in preclinical studies. A Phase 1 clinical trial, named INNATE, for JTX-8064 as a monotherapy and in combination with JTX-4014, Jounce’s internal PD-1 inhibitor, or pembrolizumab is currently enrolling patients with advanced solid tumors. Jounce’s most advanced product candidate, vopratelimab, is a monoclonal antibody that binds to and activates ICOS, and is currently being studied in the SELECT Phase 2 trial. JTX-4014 is a PD-1 inhibitor intended for combination use in the INNATE and SELECT trials and with Jounce’s broader pipeline. Additionally, Jounce exclusively licensed worldwide rights to JTX-1811, a monoclonal antibody targeting CCR8 and designed to selectively deplete T regulatory cells in the tumor microenvironment, to Gilead Sciences, Inc. For more information, please visit www.jouncetx.com.
External website https://careers-jouncetx.icims.com/jobs/1259/senior-scientist%2c-clinical-pharmacology/job
Contact email address: asloan@liverpool.ac.uk - 15th Nov 2021 [3073]
Lecturer, Senior Lecturer or Reader in Pharmacology
Job Ref: 036108
Faculty: Health and Life Sciences, Institute of Systems, Molecular and Integrative Biology, Department of Pharmacology and Therapeutics, Centre of Excellence in Long-acting Therapeutics (CELT)
Location: University Campus
Grade: 8/9 depending on experience
Salary: £42,149 - £67,538 pa (depending on experience)
Hours of Work: Full Time
Tenure: Permanent
For informal enquiries please contact Professor Andrew Owen (aowen@liverpool.ac.uk) and/or Professor Saye Khoo (khoo@liverpool.ac.uk) We are recruiting at Lecturer, Senior Lecturer or Reader level an excellent candiate to lead a research programme in the translation of advanced formulations for drug delivery applications with an emphasis on infectious diseases. You will also contribute to the delivery of our undergraduate and postgraduate teaching programmes, including our new MSc in Bioinformatics.
Liverpool has a global reputation in long-acting drug delivery and the application of in silico modelling approaches in pharmacology. You will have a background in pharmacology and evidence of success in attracting external funding and high-quality publications but consideration will be made for exceptional candidates with industry experience. You will be based within the newly formed Institute of Systems, Molecular and Integrative Biology. This provides an enviable opportunity to work across disciplines in a vibrant research environment, including collaborations with the Centre of Excellence in Long-acting Therapeutics (CELT), led by Professor Andrew Owen, and the UK national phase I/IIa COVID-19 platform trial, AGILE, led by Professor Saye Khoo.
We welcome applications from candidates demonstrating a particular interest in clinically relevant translational research, with a focus on priorities that balance innovation with need for global healthcare solutions. The team have particular interest in candidates with expertise in PK/PD modelling approaches that can be used to forecast the potential impact of novel interventions on national and international public health outcomes. Recent experience of contribution to the COVID-19 pandemic would be highly desirable. You should have an excellent CV wiand a PhD in pharmacy,pharmacology or systems biology. You will be expected to bring in external funding, develop and deliver high quality teaching and successfully supervise PhD students, with an established track record with potential to develop a world class research programme in long-acting therapeutics.
Your research will benefit from, and contribute to, a thriving research environment that includes:
Centre for Long-acting Therapeutics (CELT): a cross-faculty research initiative combining our world leading expertise in pharmacology and materials chemistry and working with international partners to disseminate research findings in long-acting medicine and change the global landscape of drug administration
AGILE: a world-class team of researchers who have collective expertise in emerging viral infections, new drug development, therapeutics, drug safety and clinical tropical medicine.
Liverpool Centre of Excellence in Infectious Disease Research (CEIDR): a flagship centre involving partners of University of Liverpool, Liverpool School of Tropical Medicine and NHS Trusts to accelerate basic and translational research in AMR, vaccines, individualised therapy and surveillance at local, national and global scales;
GeneMill Synthetic Biology Lab: BBSRC-funded facility for gene editing and synthesis;
Centre for Proteome Research (CPR): housing state-of-the art instrumentation for qualitative and quantitative proteomics, MS
imaging, MS-based structural protein analysis and single-cell proteomics
Centre for Cell Imaging (CCI): housing both confocal and wide-field luminescence microscopes;
Computational Biology Facility (CBF): providing support across the faculty in biomarker discovery, machine learning, software development, network analysis.
Centre for Metabolomic Research (CMR): develop and apply a range of NMR and LC-MS and GC-MS platforms for targeted and untargeted metabolomics, as well as utilising Raman and infrared spectroscopy for single-cell imaging.
Culture facilities ncluding dedicated cell culture, controlled temperature rooms, glasshouses, plant growth rooms, transgenic animal facilities, and Category II and III facilities for safe culture of pathogens.
Studentships including BBSRC and MRC doctoral training programmes and a strong cohort of UK and overseas post-graduate students.
External website https://www.liverpool.ac.uk/centre-of-excellence-for-long-acting-therapeutics/about-us/vacancies/
Contact email address: yun.wang4@fda.hhs.gov - 4th Nov 2021 [3072]
Great ORISE fellowship opportunity at FDA with good stipend. Please apply at Zintellect.
https://www.zintellect.com/Opportunity/Details/FDA-CDER-2022-0734
The qualified candidate should be currently pursuing or have received a doctoral degree in one of the relevant fields. Degree must have been received within five years of the appointment start date.
Preferred skills:
Familiarity with modeling and simulation software
Knowledge of PK/PD modeling principles and statistics
External website https://www.zintellect.com/Opportunity/Details/FDA-CDER-2022-0734
Contact email address: murad.m.melhem@gsk.com - 3rd Nov 2021 [3071]
The department of Clinical Pharmacology Modelling and Simulation (CPMS) at GlaxoSmithKline is recruiting a Director-level Clinical Pharmacologist with strong clinical pharmacology and pharmacometric skills. Mp< CPMS is a science-driven group using quantitative clinical pharmacology approaches, as part of the model-informed drug discovery and development (MID3) paradigm, to evolve understanding of compound behavior and optimize dose across the development continuum, delivering a competitive label. CPMS responsibilities cover the life cycle of drug development.
This position can be based at GSK US at the Collegeville, PA; Waltham, MA; or RTP, NC locations.
This role will provide YOU the opportunity to lead key activities to progress YOUR career
More details on basic qualifications and role definition/responsibilities in the links below.
https://gsk.wd5.myworkdayjobs.com/GSKCareers/job/USA---Pennsylvania---Upper-Providence/Director--Quantitative-Clinical-Pharmacology_305664-1
https://gsk.wd5.myworkdayjobs.com/GSKCareers/job/USA---Pennsylvania---Upper-Providence/Director-Quantitative-Clinical-Pharmacology--Oncology_301799-1
External website https://gsk.wd5.myworkdayjobs.com/GSKCareers/job/USA---Pennsylvania---Upper-Providence/Director--Qua
Contact email address: telder@stem-sourcing.com - 21st Oct 2021 [3069]
Director/Sr. Director Clinical Pharmacology
Our Client is currently seeking a Clinical Pharmacology leader. Reporting to the SVP Early Development, the incumbent will be the clinical pharmacology representative on project teams developing small molecule modulators as precision cancer medicines. We are looking for a consummate team player seeking a collaborative environment in which to grow their career in drug development.
Responsibilities
In partnership with functional/project leaders, set the clinical pharmacology strategy and plans for Company’s programs in clinical development. Be the functional area representative for clinical pharmacology on project teams.
Lead the planning, design, conduct and analysis of standalone clinical pharmacology studies in collaboration with internal cross-functional team. Work closely with DMPK in the design and integration of clinical PK/PD activities, collaborate with Clinical Operations in the planning and conduct of clinical PK studies.
Oversees activities including non-compartmental PK analysis, population PK, PK/PD, physiologically-based, and other modeling and simulation (M&S) approaches. Coordinates with internal and external team in the data review, analysis and reporting of clinical pharmacology sections of CSRs including PK and pharmacometrics analyses.
Author and review clinical protocols, study reports and prepare relevant sections of regulatory documents, including INDs, clinical trial applications (CTAs), Investigator Brochures, regulatory Briefing Documents and NDAs/MAAs.
Qualifications
An advanced degree and years of experience in the biotech/pharmaceutical industry, with a focus in clinical pharmacology, pharmacokinetics, pharmacometrics or related discipline.
Previous experience in managing clinical pharmacology programs, and in the design, execution, and regulatory reporting of clinical PK/PD studies is required.
Technical depth in clinical pharmacokinetics, PK/PD analysis, and M&S approaches, preferably with experience in oncology. Experience applying M&S through development a plus.
Experience conducting clinical pharmacology programs through early and late-stage development.
Operational experience and familiarity with the drug discovery and development process, including external regulatory requirements. Well versed in authoring and reviewing relevant sections of regulatory dossiers.
Proficient in the management of activities at contract research organizations and comfortable working in virtual outsourced model.
External website https://www.stem-sourcing.com
2nd Oct 2021 [3068]
ASSOCIATE DIRECTOR, CLINICAL PHARMACOLOGY, MODELING & SIMULATION
Job Title: Associate Director, Clinical Pharmacology, Modeling & Simulation Department: R&D: Clinical Reports To: Vice President of Clinical Pharmacology FLSA Status: Exempt Location: San Diego or Remote Travel: up to 10%
Summary
The Associate Director, Clinical Pharmacology (CP), Modeling & Simulation (M&S) will be a key member of the Clinical Pharmacology group and will report directly to the VP of Clinical Pharmacology. This individual will apply strong pharmacometrics skills to independently determine, plan, and execute modeling and simulation analyses.
Responsibilities
Serve as a core member of cross-functional drug development teams Serve as the M&S lead for pharmacometrics deliverables, including population PK, PK-PD, exposure-response, model-based meta-analysis, trial simulation, etc. Participate in preparation of regulatory responses and submissions, interactions with health authorities as pharmacometrics subject matter expert (SME) Collaborate with internal and external SMEs to develop and enhance pharmacometrics methodologies and capabilities Be responsible for guiding model-based efficacious dose prediction for First-In-Human studies by interpreting and integrating in vitro and in vivo data from nonclinical studies.
Qualifications
6+ years of Pharmaceutical or Biotech experience Experience with development of small molecules is a must; experience with pediatric development is a plus PhD degree in life sciences (e.g., biology, biochemistry, biophysics, or pharmacology), chemical engineering, pharmacokinetics, or related disciplines with 6+ years relevant experience in PK/PD, systems pharmacology, and mathematical modeling Expertise with modeling software including NONMEM, R etc. Experience with PBPK modeling is a plus A strong understanding of US and EU (at a minimum) and other international pharmaceutical guidelines and regulations is required, particularly ICH and GCP Excellent verbal, presentation, and written communication skills Demonstrated understanding of CMC, translational biomarkers, drug metabolism & transporters, pharmacokinetics, and drug development Ability to foster relationships within an organization and advance the concepts of model informed drug development (MIDD) Record of publications, presentations, and volunteering for professional organizations
External website https://www.longboardpharma.com/associate-director-clinical-pharmacology-modeling-simulation/
2nd Oct 2021 [3067]
Director, Clinical Pharmacology Location: San Diego or Remote Travel: up to 20%
Summary
The Director, Clinical Pharmacology (CP) will report to the VP of Clinical Pharmacology and will be a core-member of the cross-functional product development and clinical development teams. This individual will be responsible for leading efficient, innovative clinical pharmacology programs incorporating the most current scientific advances in the field and incorporating knowledge of quantitative pharmacology, drug metabolism and transporters, statistical principles to support Phase 2 and 3 clinical programs. This individual will be responsible for assigned programs and studies and accountable for all aspects of Clinical Pharmacology from protocol design, authoring, data analysis and interpretation to reporting and authoring study reports, regulatory documents, and publications. He/she will work collaboratively with CMC and non-clinical DMPK colleagues to ensure data and formulations necessary to support clinical development are planned for and delivered in a timely manner.
Responsibilities
Responsible for developing Clinical Pharmacology strategy; Phase 1 protocol design, data analysis/interpretation, and reporting by authoring study reports, regulatory documents, and publications. This includes determining scope, design, planning, and analysis of phase 1-4 PK-PD studies, including developing appropriate population PK models, and PK/PD analysis required from a development and regulatory perspective Operational oversight of Phase 1 studies and clinical studies with PK sampling to ensure data quality and fidelity Identify and manage consultants and vendors supporting clinical pharmacology studies Lead authoring for Sections 2.7.1 and 2.7.2, with contributions to clinical safety and efficacy summaries of IND and NDAs. Respond to regulatory queries during reviews and represent at face-to-face regulatory meetings Responsible for quality aspects of Phase 1 studies and be prepared to answer questions during regulatory inspection Contribute to overall compound development via application of quantitative methods to integrate knowledge of PK, PD, pharmaceutical formulations, patient characteristics, disease states, and drug-drug interactions to optimize dose selection, dosage regimens and study designs throughout drug development
Qualifications
PhD in Pharmaceutical Sciences, Clinical Pharmacology, Clinical Medicine, or relevant Biological Sciences is required. PharmD-PhDs are preferred. Strong quantitative skills are required, along with a thorough understanding of drug metabolism and transporters. 10+ years of relevant Pharmaceutical and/or Biotech work experience; small molecule development experience is a must; pediatric drug development experience is a plus Experienced in designing and overseeing operations for Phase 1 studies for small molecules. Demonstrated understanding and application of model-based drug development (MBDD) including PK-PD modeling, Population PK modeling, Exposure-Response analyses for safety and efficacy, physiological based modeling and simulation, pediatric drug development, model-based meta-analyses, trial simulations, innovative clinical trial design, statistical principles Good understanding of regulatory requirements for US and EU (at a minimum) and other international authorities. Knowledge of bioanalytical methods and regulatory requirements; ability to work with bioanalytical labs Working knowledge of biopharmaceutics principles to guide formulation development In depth understanding of clinical and regulatory landscape, disease pathophysiology and mechanisms of drug action, biomarkers, available treatment paradigms, and patient populations Record of publications and presentations at professional organizations Strong scientific reasoning ability A breadth of diverse leadership experience and capabilities including: the ability to influence and collaborate with peers, develop, and coach others, and oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact Ability to problem-solve, research issues, and propose solutions Excellent interpersonal and communication skills, both written and oral, and ability to communicate complex information succinctly Ability to function independently in fast-paced, virtual environment
External website https://www.longboardpharma.com/director-clinical-pharmacology/
Contact email address: telder@stem-sourcing.com - 22nd Sep 2021 [3066]
Director or Sr. Director of Quantitative Pharmacology/Pharmacometrics
Partner with Head of Nonclinical Development, Program Team leaders and R&D staff to lead the pharmacometrics and quantitative PK/PD strategy for Our Client’s discovery and development programs
As a member of project teams, the individual will be responsible for applying model-based approaches to support compartmental and mechanism-based PK/PD analysis, evaluation of FIH dose and regimen recommendations. Develop and execute strategies for mid-stage and late-stage Oncology programs to support regulatory questions and filings Provide due-diligence and strategic regulatory advice/evaluations for oncology drug development programs The successful incumbent will utilize a range of computational approaches (PK/PD, pharmacometrics, systems-based, informatics). The scope of project responsibility will range from late discovery through registration.External website https://www.stem-sourcing.com
17th Sep 2021 [3065]
Postdoctoral Fellowship in Pharmacokinetics/Pharmacodynamics
UNC Eshelman School of Pharmacy The University of North Carolina at Chapel Hill
A postdoctoral research associate position is available to work on projects focused on characterizing pharmacokinetics/pharmacodynamics in the pediatric population. The project will involve the use of physiologically-based pharmacokinetic (PBPK) and population pharmacokinetic (PopPK) modeling techniques to characterize the effects of age, obesity, and drug-drug interactions in pediatric patients.
Requirements: minimum of a PharmD, MD, or PhD with knowledge of pharmacokinetic/pharmacodynamic analyses. Demonstrated software proficiency (e.g., PK-Sim®, NONMEM®, R) is preferred. Excellent communication skills and the ability to work independently and as a member of an interdisciplinary team are essential.
Interested applicants should submit a letter describing personal goals related to the position, Curriculum Vitae, and three professional references at https://unc.peopleadmin.com/postings/187422.
The University of North Carolina at Chapel Hill is an equal opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to age, color, disability, gender, gender expression, gender identity, genetic information, race, national origin, religion, sex, sexual orientation, or status as a protected veteran.
External website https://unc.peopleadmin.com/postings/187422
Contact email address: dave.anderson@external.biontech.de - 10th Sep 2021 [3064]
BioNTech wants to become the world’s leading biotechnology company for individualized cancer medicine. Our dedicated, passionate pioneers achieve sensational success and promising breakthroughs time and again by forging new paths – and ensure people all around the world have hope for the future.
BioNTech is currently hiring within the Clinical Pharmacology group at the Senior Scientist & (Associate) Director levels in Cambridge, MA and Mainz, Germany.
External website https://jobs.biontech.de/Senior-Scientist-Clinical-Pharmacology-eng-j3747.html
18th Aug 2021 [3063]
We are recruiting at Lecturer or Senior Lecturer level an excellent candidate to lead a research programme in the translation of advanced formulations for drug delivery applications with an emphasis on infectious diseases. You will also contribute to the delivery of our undergraduate and postgraduate teaching programmes, including our new MSc in Bioinformatics.
Liverpool has a global reputation as a key player in long-acting drug delivery and the application of in silico modelling approaches in pharmacology. You will have a background in pharmacology and evidence of success in attracting external funding and high-quality publications. You will be based within the newly formed Institute of Systems, Molecular and Integrative Biology. This provides an enviable opportunity to work across disciplines in a vibrant research environment, including collaborations with the Centre of Excellence in Long-acting Therapeutics (CELT), led by Professor Andrew Owen, and the UK national phase I/IIa COVID-19 platform trial, AGILE, led by Professor Saye Khoo.
We welcome applications from candidates demonstrating a particular interest in clinically relevant translational research, with a focus on priorities that balance innovation with need for global healthcare solutions. The team have particular interest in candidates with expertise in modelling approaches that can be used to forecast the potential impact of novel interventions on national and international public health outcomes (including economic and broader healthcare impacts). You should have an excellent CV with evidence of success in attracting external funding and high-quality publications plus a PhD in pharmacy or pharmacology. You will be expected to bring in external funding, develop and deliver high quality teaching and successfully supervise PhD students, with an established track record with potential to develop a world class research programme in long-acting therapeutics.
Your research will benefit from, and contribute to, a thriving research environment that includes:
Centre for Long-acting Therapeutics (CELT): a cross-faculty research initiative combining our world leading expertise in pharmacology and materials chemistry and working with international partners to disseminate research findings in long-acting medicine and change the global landscape of drug administration AGILE: a world-class team of researchers who have collective expertise in emerging viral infections, new drug development, therapeutics, drug safety and clinical tropical medicine. Liverpool Centre of Excellence in Infectious Disease Research (CEIDR): a flagship centre involving partners of University of Liverpool, Liverpool School of Tropical Medicine and NHS Trusts to accelerate basic and translational research in AMR, vaccines, individualised therapy and surveillance at local, national and global scales; GeneMill Synthetic Biology Lab: BBSRC-funded facility for gene editing and synthesis; Centre for Proteome Research (CPR): housing state-of-the art instrumentation for qualitative and quantitative proteomics, MS imaging, MS-based structural protein analysis and single-cell proteomics; Centre for Cell Imaging (CCI): housing both confocal and wide-field luminescence microscopes; Computational Biology Facility (CBF): providing support across the faculty in biomarker discovery, machine learning, software development, network analysis. Centre for Metabolomic Research (CMR): deploying a range of NMR and mass-spec platforms for targeted and untargeted metabolomics and RAMEN single-cell metabolite imaging. Culture facilities including dedicated cell culture, controlled temperature rooms, glasshouses, plant growth rooms, transgenic animal facilities, and Category II and III facilities for safe culture of pathogens. Studentships including BBSRC and MRC doctoral training programmes and a strong cohort of UK and overseas post-graduate students.
External website https://www.liverpool.ac.uk/centre-of-excellence-for-long-acting-therapeutics/about-us/vacancies/
Contact email address: arman.rahmim@ubc.ca - 13th Aug 2021 [3062]
The University of British Columbia (UBC) and BC Cancer Research Institute (BCCRI), in collaboration with the National Institutes of Health (NIH) Clinical Center, are seeking talented post-doctoral fellows to join us either in Vancouver, BC, Canada, or Bethesda, MD, USA. The research will take place with the Quantitative Radiomolecular Imaging and Therapy lab (Qurit.ca) under the guidance of Drs. Carlos Uribe, Babak Saboury and Arman Rahmim, in collaboration with Dr. Anil Maharaj of UBC.
https://my.applychance.com/Home/Show/113
External website https://my.applychance.com/Home/Show/113
Contact email address: cornelia.boehnstedt@fu-berlin.de - 25th Jul 2021 [3061]
CALL FOR APPLICATIONS within the interdisciplinary PhD program PharMetrX
The Graduate Research Training Program PharMetrX: Pharmacometrics and 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 and 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 and Network) offers a specifically tailored training program of compact modules that convey the foundations in pharmacokinetics and pharmacodynamics, systems biology, statistics, methodological approaches of modelling and 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 2021.
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 and Wilhelm Huisinga Program Chairs
External website https://www.PharMetrX.de
Contact email address: telder@stem-sourcing.com - 12th Jul 2021 [3060]
This late-stage biopharmaceutical company has promising novel molecules in the field of organ repair, kidney, lung and other organs.
Their main compound mimics the activity of the endogenous HGF that is critical in the body’s natural process of organ repair and is a highly selective oral bioavailable small molecule developed for the potential treatment of fibrotic diseases.
There are several other molecules and programs earlier in the pipeline.
The new hire will be part of the brainstorming process together with very high-level contributors in the company,
Clin Pharm is also responsible for BA and DMPK so the work so the work is diverse, never boring and the team is exceptional.
In just 2 years the company has moved from a research company to a late stage company. Please message me to learn more telder@stem-sourcing.com
External website https://www.stem-sourcing.com