PK/PD and Other Jobs

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Contact email address: Melanie.Joy@cuanschutz.edu - 19th May 2022 [3102]

Fellowship Opportunity

Location. University of Colorado, Skaggs School of Pharmacy

Job Description. A Postdoctoral Research position is available in the Skaggs School of Pharmacy, Department of Pharmaceutical Sciences. Projects will encompass pharmacokinetic/pharmacodynamic modeling of drugs and biologics for kidney disease treatments and as a tool to study renal injury. Research will also involve in vitro, animal and human studies to delineate transport, metabolism, and pharmacodynamics. Previous experience with biomarkers for treatment responses and toxicities is desirable.

Educational Requirements. PhD or MD

Qualifications and Experience

Interested applicants should submit a letter describing personal goals related to the position, Curriculum Vitae, and three professional references to Melanie S. Joy, PharmD, PhD, Professor, Director of Pharmaceutical Science Innovation and Commercialization, University of Colorado, Skaggs School of Pharmacy and Pharmaceutical Sciences (Melanie.Joy@cuanschutz.edu)

Start Date. July 2022
Location. Aurora, Colorado, USA


Contact email address: telder@stem-sourcing.com - 2nd May 2022 [3101]

Director / Senior Director - Clinical Pharmacology

Our Client is a precision oncology medicine company looking for a consummate team player seeking a collaborative environment in which to grow their career in drug development.

Responsibilities
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. Experience applying M&S through development a plus. Experience conducting clinical pharmacology programs through early and late-stage development. 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


29th Apr 2022 [3100]

At Roche, we believe it’s urgent to deliver medical solutions right now – even as we develop innovations for the future. We are passionate about transforming patients’ lives and we are fearless in both decision and action. And we believe that good business means a better world.

That is why we come to work each day. We commit ourselves to scientific rigor, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow.

In Roche’s Pharmaceutical Research and Early Development organisation (pRED), we make transformative medicines for patients in order to tackle some of the world’s toughest unmet healthcare needs. At pRED, we are united by our mission to transform science into medicines. Together, we create a culture defined by curiosity, responsibility and humility, where our talented people are empowered and inspired to bring forward extraordinary life-changing innovation at speed. These positions are located in the Predictive Modeling and Data Analytics chapter, a chapter within the Pharmaceutical Sciences function, where Pharmacometrics is a primary focus area. We closely collaborate with our therapeutic areas and functions to convert hypotheses into innovative therapeutics.

As a pharmacometrician you contribute to developing medicines by designing and executing the pharmacometric strategy for programs in different stages of clinical development in one or more indication or disease areas. The pharmacometrics positions are located in the Predictive Modeling and Data Analytics chapter, where pharmacometrics is a primary focus area, together with other quantitative functions in Pharmaceutical Sciences. As a pharmacometrician you closely collaborate with other functions in pRED and development to ensure that the pharmacometric support is addressing the key needs to bring projects forward.

Your Responsibilities include:

Your profile Your location
This position is located in Basel or in Welwyn.
You’re someone who wants to influence your own development. You are looking for a company where you receive the opportunity to pursue your interests across functions and geographies. Working in a multi-cultural environment motivates you.

Are you ready to apply? We want someone who thinks beyond the job offered - someone who knows that this position can be a rare springboard to many other opportunities at Roche.

Roche embraces diversity and equal opportunity in a serious way. We are committed to building a team that represents a variety of backgrounds, perspectives, and skills. The more inclusive we are, the better our work will be.

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

Job Level:
Individual contributor

External website https://roche.wd3.myworkdayjobs.com/de-DE/roche-ext/job/Basel/Pharmacometricians-permanent-contract_


11th Apr 2022 [3099]

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.

Minimum Education and Experience Requirements: PharmD, MD, or PhD with knowledge of pharmacokinetic/pharmacodynamic analyses.

Required Qualifications, Competencies, and Experience: excellent communication skills and the ability to work independently as well as a member of an interdisciplinary team are essential.

Preferred Qualifications, Competencies, and Experience: demonstrated software proficiency (e.g., PK-Sim, NONMEM, R) is preferred.

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/226938


Contact email address: gobeaun@mmv.org - 31st Mar 2022 [3098]

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 two PKPD Modelling and Simulation scientists to join our Pharmacometrics team. Both are permanent positions based in Geneva, Switzerland (partially remote currently Covid-remote).

The seniority level (Manager/Associate Director) will depend on the experience of the succesful candidates.

PRIMARY DUTIES AND RESPONSIBILITIES:

EDUCATION AND EXPERIENCE:

START DATE: As soon as possible

DEADLINE: April 22, 2022

External website https://www.mmv.org/about-us/work-us/jobs#openings-list


Contact email address: telder@stem-sourcing.com - 21st Mar 2022 [3096]

Director / Senior Director - Clinical Pharmacology

Our Client is a precision oncology medicine company looking for a consummate team player seeking a collaborative environment in which to grow their career in drug development.

Responsibilities
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. Experience applying M&S through development a plus. Experience conducting clinical pharmacology programs through early and late-stage development. 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: jchapman@haallc.com - 10th Mar 2022 [3095]

Scientist/Sr. Scientist - Clinical Pharmacology

Key Responsibilities

Experience Level

External website https://haallc.com/career-opportunities/


Contact email address: jchapman@haallc.com - 10th Mar 2022 [3094]

Associate Director/Director of Clinical Pharmacology

Key Responsibilities

Experience Level

External website https://haallc.com/career-opportunities/


Contact email address: jchapman@haallc.com - 10th Mar 2022 [3093]

Pharmacometrician

Key Responsibilities

Job Requirements

External website https://haallc.com/career-opportunities/


Contact email address: jchapman@haallc.com - 10th Mar 2022 [3092]

Head of Pharmacometrics

Key Responsibilities

Experience Level

External website https://haallc.com/career-opportunities/


Contact email address: broseberry@cartermackay.com - 8th Mar 2022 [3091]

I have an Associate Director, Quantitative Clinical Pharmacology role with a global pharma client. It is a hands on as well as strategic role within pharmacometrics along with exposure in clinical pharmacology. This role can be remote, or done from offices in MD, NJ, or MA. Please contact me at broseberry@cartermackay.com for more info

Supports all pharmacometrics activities related to pre-IND, IND, phase1-3, PK, PK/PD and regulatory submissions. Supports planning, execution and reporting of pharmacometrics analyses. Provides input into all phases of drug development including, but not limited to dose finding, dose optimization, exposure-response and pediatric development. Author of clinical pharmacology and pharmacometrics submission documents and representative of the department at different product development team meetings. Conducts pharmacometrics and simulation and modeling activities to provide input on modeling and simulation activities. Interacts with early development and business development team members as well as external collaborators to assess/lead development and selection of pre-IND and early phase assets.

Job Description

Qualifications/ Required Skills: Educational Qualifications
PhD in pharmacometrics (or a related area such as pharmacokinetics, clinical pharmacology, pharmacology, or a related area) with a minimum of 5 years of experience in these areas. Strong technical and hands on experience in population PK and PK/PD modeling.
Contact email address: leola.liu@af-recruiting.com - 28th Feb 2022 [3090]

Primary Function: Zai Lab is seeking a clinical pharmacology expert to lead the clinical pharmacology function at Zai Lab and provide support for clinical development stage projects. This critical role will be a key member of the development leadership team. Specific functional responsibilities include design and conduct of PK studies, in vitro/in vivo drug metabolism, PK/PD modeling and analysis support for small molecule and antibody projects. In addition, this leadership position will lead the clin pharm team to generate all clin pharm data and reports required for regulatory submissions.

Major Responsibilities and Duties:

Qualifications:
Contact email address: telder@stem-sourcing.com - 22nd Feb 2022 [3089]

Associate Director / Principal Scientist - Clinical Pharmacology

Our Client is a precision oncology medicine company pioneering the discovery and development of MasterKey therapies. Our Client targets undrugged mutations in patients with genetically defined cancers for whom limited treatment options currently exist. Our Client is built upon a deep understanding of cancer genetics, protein structure and function, and medicinal chemistry. The Company’s proprietary technology platform, Mutation-Allostery-Pharmacology, or MAP, platform, is designed to allow Our Client to analyze population-level genetic sequencing data to identify oncogenic mutations that promote cancer across tumor types, group these mutations into families and develop a single therapy that targets a specific family of mutations, termed a MasterKey therapy. Our Client is currently seeking a Clinical Pharmacology project 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 Our Client’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 6-8+ 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.
Excellent communication and organizational skills; comfortable navigating complexity and ambiguity in a fast-paced environment interacting with consultants, external vendors and internal cross-functional, global project teams.

External website https://www.stem-sourcing.com


Contact email address: brendan.johnson@priovanttx.com - 13th Feb 2022 [3088]

Fellow, Early Phase Development

Overview
Priovant Therapeutics is committed to developing therapies that address high unmet need in autoimmune disease. This one-year Fellowship will provide a broad overview and real-world experience of the drug development process. We are seeking self-motivated graduates who are passionate about pursuing a research career within the pharmaceutical industry. The Fellow will have the opportunity to network with Priovant employees, learn about the company, and gain hands-on drug development experience with a focus on translational medicine, clinical pharmacology, and clinical development. This position will report to the SVP, Early Development.

Start: July 2022 (earlier start date optional)

Location: Durham, NC

Contact: Brendan Johnson, Ph.D. Senior Vice President, Early Development priovanttx.com

Responsibilities
Assist in the creation of nonclinical, clinical pharmacology, and clinical development strategies for Priovant assets
Understand and participate in the design, analysis, and
interpretation of nonclinical and clinical studies
Assist in drafting of study-related and regulatory documents
Perform exploratory quantitative analyses using nonclinical and clinical data
Perform literature reviews and benchmarking analyses to aid decision making
Be directly involved in cross-functional project team activities and make meaningful contributions to research programs for investigational drugs

Qualifications
Completed a US-based PharmD or PhD degree program in Pharmacokinetics, Pharmacology, Pharmaceutics, Biomedical Engineering, or a related field
Experience as a laboratory assistant, research assistant, or other prior relevant internship/work research experience
High-energy, motivated self-starter with an entrepreneurial spirit
Excellent communication skills
Desire to work in a quickly changing, fast-paced environment
Hands-on, roll-up-your-sleeves approach, with a high sense of urgency and drive for results
Ability to overcome ambiguity and challenge the status quo.
Eligibility to work in the US for the duration of employment


3rd Feb 2022 [3087]

Fellow, Early Phase Development

Overview
Priovant Therapeutics is committed to developing therapies that address high unmet need in autoimmune disease. This one-year Fellowship will provide a broad overview and real-world experience of the drug development process. We are seeking self-motivated graduates who are passionate about pursuing a research career within the pharmaceutical industry. The Fellow will have the opportunity to network with Priovant employees, learn about the company, and gain hands-on drug development experience with a focus on translational medicine, clinical pharmacology, and clinical development. This position will report to the SVP, Early Development.

Start: July 2022 (earlier start date optional)

Location: Durham, NC

Contact: Brendan Johnson, Ph.D. Senior Vice President, Early Development priovanttx.com

Responsibilities

Qualifications
Contact email address: a.chan@uci.edu - 26th Jan 2022 [3086]

The School of Pharmacy & Pharmaceutical Sciences at University of California, Irvine, is seeking outstanding applicants for an Applied Pharmacology Faculty position, which also serves as the Founding Director of the Bioanalysis Program within the Department of Clinical Pharmacy Practice. The School of Pharmacy & Pharmaceutical Sciences is one of the five units under the Susan and Henry Samueli College of Health Sciences. The college is part of the integrated UC Irvine Health system that also encompasses UCI’s clinics and Orange County’s only academic medical center. Candidates at the associate or full professor rank will be considered. This is a tenured position.

The successful candidate will establish a program to facilitate the quantitative bioanalysis of preclinical and clinical samples using state-of-the-art instrumentation in analytical chemistry, clinical pharmacology, pharmacogenetics, pharmacokinetic modeling, and molecular biology. Core facilities available on campus include the Genomics High-Throughput Facility and Mass Spectrometry Facility. The candidate is expected to collaborate with clinicians and scientists within UCI to create a clinical research program supporting bench-to-bedside translational research endeavors. Potential collaborative opportunities available on campus include the UC Irvine Institute for Clinical and Translational Science, the UC Irvine Institute for Memory Impairments and Neurological Disorders, the UCI Microbiome Initiative, the Chao Comprehensive Cancer Center, and the Institute for Genomics and Bioinformatics.

The successful candidate will also be expected to provide didactic teaching, in the areas of pharmacometrics and pharmacokinetics, to Pharm.D. and Ph.D. students. This position will report to the Chair of the Department of Clinical Pharmacy Practice.

In addition to the basic qualifications listed below, excellent interpersonal, written, verbal communication skills and ability to work in a team are essential.

Salary and appointment level will be commensurate with qualifications and experience and based on published UC pay scales. Review of applications will begin immediately, and the position will remain open until filled.

Application Procedures – Submit a cover letter, CV, names of three references, teaching statement and a diversity statement which addresses past and/or potential contributions to diversity, equality and inclusion. Submit these items via UC Irvine’s online application system, RECRUIT, located at: https://recruit.ap.uci.edu/JPF07248

Please feel free to reach out to me at a.chan@uci.edu

External website https://recruit.ap.uci.edu/JPF07248


Contact email address: telder@stem-sourcing.com - 12th Jan 2022 [3085]

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

Qualifications Superior Skills/Abilities:

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


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:

Application: Interested applicants should submit a letter describing personal goals related to the position and Curriculum Vitae to Dr. Jing Li (LiJing@wayne.edu).
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


The following are desirable:


Responsibilities

External website https://scismic.com/jobs/pbpk-modeler


Last update: Thu 19 May 2022 05:33:53 am


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