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
- Ability to work independently on assigned projects
- Knowledge and application in the areas of pharmacokinetics and pharmacodynamics
- Experience with pharmacokinetic software for nonlinear mixed effects modeling (e.g., NONMEM, Phoenix) and PBPK modeling (e.g., Symcyp Simulator)
- Skills conducting in vitro studies to delineate transport, metabolism, and pharmacodynamics
- Experience with pre-clinical and clinical translational pharmacology studies
- Publications in well-respected journals and record of high productivity
- Excellent communication skills
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:
- Develop and execute scientifically sound, innovative and business-oriented Modeling & Simulation (M&S) strategic plans for projects in various disease areas and different stages of product development, including regulatory submissions.
- Develop and execute appropriate (population) pharmacokinetic and (population) pharmacodynamic models for the project and apply, if available for the project, empirical and/or mechanistically-based drug disease models.
- Conduct simulations to inform drug development decisions such as dosage regimen selection and other trial design features.
- Communicate the outcome of M&S analysis to the project teams to support efficient discussion and decision making.
- Contribute to responses to health authority requests and interactions to align on Clinical development and M&S strategy
- Interact on a scientific level with partners in project team(s) with regards to all aspects of the application of M&S to ensure efficient and appropriate integration of M&S strategy and results into internal and external project documents (e.g. Clinical Development Plan, Investigator Brochure, NDA documents)
- MD, PharmD or PhD (in natural sciences, mathematics, physical sciences or engineering or any combination of these) with at least 3-5 years experience* in planning and conducting M&S projects for clinical study data in a pharmaceutical industry setting.
- Strategic mindset and understanding of how and when M&S can contribute value in drug development and support decision making.
- Significant experience with M&S software (e.g. NONMEM, Monolix, Phoenix, MATLAB, Gastroplus, Simcyp, SAS, R,…)
- Knowledge in technological advances like bayesian modelling and artificial intelligence (e.g. machine and deep learning) is desired as well as a keen interest for deep understanding of disease biology.
- Ability to influence and lead without authority in a network organization
- You exhibit a growth mindset. You ask for feedback and act on it. You embrace opportunities to gain new skills and perspectives and provide honest feedback to others to help them grow.
- You are able to follow the science. You act on facts and data, not opinions and go where the science and the unmet needs of patients lead you.
- Efficient written and oral communication.
- You are able to radically simplify and prioritize for impact. You invest your time in things that accelerate progress for patients. You stop doing things that do not.
- The seniority level of the position will be determined based on the experience of the successful candidate
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:
- 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: 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
- Utilize model-based drug development strategies to support dosage selection.
- Analyze and report on PK/PD, population PK, meta-analysis, and modeling and simulation data.
- Present findings at conferences and in peer-reviewed journals.
- Contribute to regulatory submissions.
- Ph.D. in Clinical Pharmacology, Pharmacokinetics, Pharmaceutical Sciences, or related discipline.
- 2-5+ years of industry experience.
- Knowledge of clinical pharmacology and pharmacometrics principles and applications.
- Experience analyzing population PK and PK/PD data, performing modeling and simulation, among other quantitative pharmacology activities.
- Experience using modeling software such as NONMEM, WinNonlin, among others.
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
- Design and implement clinical pharmacology studies.
- Provide expert support to model-based drug development.
- Lead the analysis of PK/PD data using modeling and simulations, and report on findings.
- Support dosage selection and go/no-go decisions.
- Help maintain regulatory compliance in the teams, which includes contributing to regulatory submissions and attending meetings.
- Ph.D. in Clinical Pharmacology, Pharmacokinetics, Pharmaceutical Sciences, or related field.
- 8-10+ years of industry experience.
- Experience working with PK, PK/PD, and clinical pharmacology principles and applications.
- Modeling and simulations expertise including work with modeling software such as NONMEM, WinNonlin, and Phoenix.
External website https://haallc.com/career-opportunities/
Contact email address: jchapman@haallc.com - 10th Mar 2022 [3093]
Pharmacometrician
Key Responsibilities
- Serve as the project representative, while working with other head Pharmacometricians.
- Apply modeling and simulation practices to conduct analysis of pharmacometrics data, and ensure optimal design and implementation.
- Work in collaboration with the project teams to implement the pharmacometrics strategies.
- Responsible for the delivery and preparation of appropriate documents, including regulatory documents.
- Keep up-to-date with new methods to continually improve the infrastructure.
- Ph.D. in relevant field and industry experience in pharmacometrics, PBPK, and/or systems pharmacology.
- 5-10 years of industry experience.
- Knowledge of modeling and simulation software (WinNonlin, NONMEM, MATLAB, etc.).
- Experience analyzing pharmacometrics data and applying pharmacometrics in drug development.
External website https://haallc.com/career-opportunities/
Contact email address: jchapman@haallc.com - 10th Mar 2022 [3092]
Head of Pharmacometrics
Key Responsibilities
- Serve as the pharmacometrics project representative on cross-functional teams.
- Develop and implement modeling and simulation plans and strategies.
- Support model-based drug development in support of dosage selection and go/no-go decisions.
- Manage timelines and budgets of the teams.
- Support regulatory activities and maintain overall regulatory compliance.
Experience Level
- Ph.D. in Pharmacokinetics, Pharmacometrics, or related discipline.
- 10-15+ years of industry experience.
- Experience working with clinical pharmacology, PK/PD, and/or pharmacometrics.
- Strong modeling and simulation expertise.
- Experience managing a multi-functioning group.
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
- Conducts pharmacometrics activities related to study design, protocol development, study execution, reporting and interpretation of data.
- Conducts population PK, PK/PD and modeling and simulation.
- Provides pharmacometrics analysis and participates in activities related to analysis and reporting of population PK and PK/PD analyses.
- Authors pharmacometrics sections of clinical pharmacology documents for regulatory filings including annual reports, investigator’s brochure, IND/NDA applications and pediatrics development plans.
- Work with bioanalytical team members on activities related to sample management, pharmacogenomics and biomarker development and provide analysis support related to PK and PK/PD.
- Work with formulation development groups and provide support for PK and PK/PD activities related to formulation development, in vivo-in vitro correlations and biowaivers for pre- and post-approval formulations.
- Manage pharmacometrics activities related to project budgets, outsourcing of PK and PK/PD analyses, contract requisition, SOW and approval of invoices.
- Interact with clinical pharmacology to support population PK and PK/PD modeling
- Serve as pharmacometrics lead on multiple project teams and as a team member on other key projects as needed and supports model-based drug development strategies for ongoing projects.
- Knowledge, Skills, and Competencies:
- In-depth knowledge of pharmacometrics, population PK and PK/PD modeling, clinical pharmacology, drug metabolism, biopharmaceutics, and bioanalytical chemistry.
- Hands PK and PK/PD analysis and statistical analysis using NonMEM, Phoenix NLME, Julia, R etc.
- Excellent working knowledge of phase I clinical operations, drug development, multi-region regulatory requirements.
- Good working knowledge of formulation development, drug development and clinical development.
- Current awareness of the latest developments in clinical pharmacology and guidance documents.
- Must be able to apply scientific knowledge (in the areas specified above) to further the company’s products, anticipate and identify core problems, apply insightful analysis, and solve problems effectively.
- Strong technical and hands on experience related to pharmacometrics, population PK and PK/PD modeling
- Strong organization skills.
- Strong communication skills.
- Flexibility to react rapidly to changing situations/environment
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:
- Provide strategic oversight for clinical pharmacology studies at Zai Lab and establish goals and project plans for the clin pharm function including modeling and simulation and bioanalytics
- Design and develop strategy and plans for clin pharm/PK evaluation of small molecule and antibody therapeutics
- Oversee quality and performance of all clin pharm activities including interactions with alliance partners, CROs and external project support.
- Oversee all clin pharm data analysis, PK/PD modeling &simulation and prediction to provide human dose projections and exposures; integrate, interpret and report data to Clinical teams and management.
- Act as the clin pharm lead for development stage projects.
- Identify and implement the appropriate assays and technologies relevant to ADME-DMPK characterization for discovery and development projects at Zai
- Prepare and present internal and external documentation relating to regulatory documents (e.g. IND, CTA, Protocols annual reports and IBs).
- PhD in clinical pharmacology, pharmacokinetics, drug metabolism or related field with a minimum of 10 years industrial experience or equivalent in the evaluation of small molecule or antibody therapeutics. An excellent understanding of early stage development processes for oncology therapeutics is highly desired.
- Demonstrated knowledge of regulatory requirements and expectations for nonclinical DMPK packages to support first-in-human and clinical development studies including thorough knowledge of GLP, GCP, ICH and other applicable guidelines.
- Experience in the outsourcing and external oversight of clin pharm/PK studies Ability to communicate clearly and effectively with project teams, management and CROs.
- Strong leadership abilities with project and team management experiences
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
- 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
- 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
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
- 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
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