PK/PD and Other Jobs

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Contact email address: telder@stem-sourcing.com - 2nd Aug 2022 [3108]

Our client is the world's fastest growing biotech and pharma company with over 1000 hires last year. They are seeking a Quantitative Pharmacology Director or Sr. Dir. This exceptional scientist:

Possesses a deep understanding of scientific literature and technical skills in a number of PK/PD methods and techniques. Has extensive knowledge base of the work in overall scientific community in own discipline.

Is recognized as an expert in own area within the organization. Has extensive regulatory experience through authoring of regulatory briefing books, CTD summaries, contribution at HA meetings, HA negotiations through regulatory reviews and approvals of BLA or equivalent.

Please message me to learn more telder@stem-sourcing.com

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


5th Jul 2022 [3106]

Description

The Department of Discovery Drug Metabolism and Pharmacokinetics in Evotec Verona is looking for an enthusiastic and dedicated Scientist with a track record within the field pharmacokinetics and PKPD M&S to support the characterisation, profiling and selection of drug candidate molecules for different modalities (i.e. Small molecule, RNA targeting and Therapeutic mAb). The candidate will be expected to spend most of his/her time in M&S of PK and PKPD data and to prepare and deliver written and oral work summaries to project teams and clients. Project teams at Evotec are interdisciplinary and require strong team players with effective communication and strong flexibility. Significant components of the role include technical leadership/ownership.

Your Job And Key Responsibilities
Provide PK, PKPD and PBPK modelling expertise to drug discovery projects using industry standard software (i.e. WinNonlin/Phoenix, NONMEM, PK-Sim and GastroPlus) As DMPK project representative, or in conjunction with DMPK project representatives, plan, design and report PK and PKPD studies supporting drug discovery projects for multiple modalities (i.e. Small molecule, RNA targeting and Therapeutic mAb) Work closely and effectively with drug discovery partners, particularly chemistry, biology, safety/toxicology and formulation teams Maintain high level of quality and reliability

Qualifications
Our preferred candidate has the following personal and professional qualifications: Relevant scientific degree or PhD Minimum of 2 years’ industrial experience supporting research/preclinical projects Awareness and understanding of the role of DMPK in Research & Development Solid hands-on experience within M&S of translational PK and PKPD data Solid hands-on experience within PBPK simulation including human PK prediction Efficient, goal oriented and independent work style with flexible mind-set Team player with strong collaboration and communication skills Able to build strong relationships both internally and externally, with colleagues, suppliers and clients Fluent in oral and written English

PLEASE APPLY NOW!

External website https://www.linkedin.com/jobs/view/3137716290/?refId=av%2FQl1iQR5u%2BBTEPrhhHSA%3D%3D


29th Jun 2022 [3105]

POST DOCTORAL RESEARCH ASSOCIATE (PDRA) in PHARMACOKINETIC/ MATHEMATICAL MODELLING Pharmacology & Therapeutics

Closing: 12-Jul-2022 23:30

We are seeking an experienced individual to work as a PDRA in PK/PD modelling for a National Institutes of Health (NIH) (USA) funded project. The role will provide support within the Modelling and Simulation Core service as part of the Long-Acting/Extended Release Antiretroviral Resource Program (LEAP). You will work under the direction of Professor Andrew Owen and other delegates within the team. You will join a multi-disciplinary team of pharmacologists and chemists working on research into the development of the next generation of long-acting candidate medicines. You should have a PhD in Pharmacology or related discipline and expertise in mathematical modelling.

The post is available from 1st July until 31st December 2022 initially with a view to further extension.

The University has the right to close the vacancy early if it is deemed that there have been enough applications received

External website https://my.corehr.com/pls/ulivrecruit/erq_jobspec_version_4.display_form?p_company=1&p_internal_external=E&p_display_in_irish=N&p_process_type=&p_applicant_no=&p_form_profile_detail=&p_display_apply_ind=Y&p_refresh_search=Y&p_recruitment_id=044047


Contact email address: telder@stem-sourcing.com - 3rd Jun 2022 [3103]

Our Client is a biopharmaceutical company developing a new generation of oral integrin therapies for the treatment of serious chronic diseases, including autoimmune, cardiovascular and metabolic diseases, fibrosis and cancer. In collaboration with AbbVie, Janssen and Schrödinger, Our Client is advancing its pipeline and discovery activities using its proprietary technology platform which leverages the Company’s unique understanding of integrin structure and biology.

Our Client is advancing both partnered and fully-owned oral integrin therapeutic candidates with the initial clinical trials beginning in the 2020. Our immediate focus is on the areas where the clinical activity of antibody inhibitors of integrins is precedented, thus enabling a rapid path to clinical proof-of-concept. Our Client Therapeutic is located in Waltham, MA. We are seeking a highly talented and motivated individual to join our culture of teamwork, craftsmanship, tenacity, compassion, and integrity.

Job description
The successful candidate will have the opportunity to use quantitative methodologies to shape the overall clinical development plan for Our Client drug candidates. The position will be part of a multi-disciplinary drug development team working together towards transformative small molecule therapeutics for autoimmune and fibrotic diseases. In-depth experience in quantitative PK and PD data analysis is required.

Responsibilities

Qualifications

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


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

Last update: Tue 2 Aug 2022 03:16:46 pm


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