CALL FOR APPLICATIONS within the interdisciplinary PhD program PharMetrX
The Graduate Research Training Program PharMetrX: Pharmacometrics and Computational Disease Modelling is an interdisciplinary PhD program bridging pharmacy and mathematics. It aims at understanding the drug-patient-disease interaction by analysing data of drug concentration, effect & disease profiles of pre-/clinical trials and of therapeutic care by developing and using mathematical & statistical models.
We are currently inviting applications to enrol in the PharMetrX Research+ Program or the PharMetrX Training+ Program.
The PharMetrX Research+ Program (Research & Training and Network) comprises an excellent research environment in the vibrant Berlin/Potsdam area, fascinating and innovative research projects in a highly relevant field, truly transdisciplinary supervision, an individual mentorship from one of the associated industry partners, a specifically tailored training program of compact modules, a network of peers and a highly competitive 3.5 years fellowship.
The PharMetrX Training+ Program (Training and Network) offers a specifically tailored training program of compact modules that convey the foundations in pharmacokinetics and pharmacodynamics, systems biology, statistics, methodological approaches of modelling and simulation etc. as well as a network of peers. It is open for PhD students who have already started their PhD in the field of pharmacometrics or will do so soon.
Both programs are open to candidates with a university degree in pharmacy, pharmaceutical sciences, mathematics/statistics, bioinformatics, life sciences or medicine. See https://www.PharMetrX.de for further details.
Deadline for applications: 15 September 2021.
PharMetrX is a joint program of Freie Universität Berlin and the University of Potsdam, supported by a consortium of global research-driven pharmaceutical companies.
Charlotte Kloft and Wilhelm Huisinga Program Chairs
External website https://www.PharMetrX.de
Contact email address: telder@stem-sourcing.com - 12th Jul 202 [3060]
This late-stage biopharmaceutical company has promising novel molecules in the field of organ repair, kidney, lung and other organs.
Their main compound mimics the activity of the endogenous HGF that is critical in the body’s natural process of organ repair and is a highly selective oral bioavailable small molecule developed for the potential treatment of fibrotic diseases.
There are several other molecules and programs earlier in the pipeline.
The new hire will be part of the brainstorming process together with very high-level contributors in the company,
Clin Pharm is also responsible for BA and DMPK so the work so the work is diverse, never boring and the team is exceptional.
In just 2 years the company has moved from a research company to a late stage company. Please message me to learn more telder@stem-sourcing.com
External website https://www.stem-sourcing.com
Contact email address: broseberry@cartermackay.com - 17th Jun 202 [3059]
New role available in MA, or can be WFH minimal travel. Small molecule drug development. Please contact me for more info and this role is responsible for company pharmacometrics strategy development. It is a “first in” highly impactful role.
The AD/Director/Sr. Director, Pharmacometrics will be responsible for developing and executing modeling/simulation strategies for compounds from the early through late-stage clinical development. This individual will participate and serve as the SME in cross-functional discovery and development project teams and this position will play a key role in establishing and strengthening the computational/quantitative infrastructure of the company through the use of pharmacometrics practices. This role will be responsible for executing internal assignments independently and/or in collaboration with external CROs.
Primary Responsibilities
- Hands-on development and implementation of fit-for-purpose mathematical models
- Develop robust translational and population PK and PK-PD and exposure-response models
- Contributes to FIH dose selection, safety margin assessment, dose optimization and drug-biomarker/disease evaluation
- Proactively identifies opportunities to integrate model-based approaches into development plans
- Responsible for developing M&S plans
- Manage pharmacometrics CROs
- PhD in Pharmaceutical Sciences, Pharmacokinetics, Clinical Pharmacology or related quantitative fields
- 8+ years of relevant experience
- Demonstrated expertise in the application of M&S for decision making
- Proficient in the use of NONMEM, R, Phoenix, SAS or other similar tools
Contact email address: telder@stem-sourcing.com - 15th Jun 202 [3058]
Clinical Pharmacologist/Associate Director Clinical Pharmacology
Our client is seeking an experienced Clinical Pharmacologist Associate Director with 7 or more years of experience to join a team of highly motivated scientists who are translating fundamental insights into novel therapies. Reporting directly to the Senior Director of Clin Pharm, this is a unique opportunity to take on a role with a broad range of responsibilities.
The Clinical Pharmacologist / Associate Director will assume primary responsibility for providing DMPK and clinical pharmacology expertise to discovery and development teams. The successful candidate will have broad subject expertise including clinical pharmacology and pharmacokinetics with experience in the design, execution and interpretation of results, managing studies contracted to CRO’s and applying this knowledge to the advancement and selection of drug candidates.
Responsibilities:
Provide expert PK, and clinical pharmacology to support compound advancement and evaluation Clinical Pharmacology: Conducts the analysis, interpretation and reporting of clinical and non-clinical pharmacokinetic data. Helps plan, conducts and reports quantitative analyses to select / optimize doses, dosage regimens throughout clinical drug development Regulatory: Manage the preparation and/or presentation of nonclinical pharmacology sections of external documents (e.g. Investigator’s Brochure, IND/ CTA,NDA.)Pharmacometrics: Performs exposure-response and PBPK modeling using a variety of software, CRO oversight: delivers critical project data through a network of external study providers. In collaboration with project teams, participate in study design, troubleshooting, data analysis and interpretation, Reviews study reports, DMPK: Utilize animal models, define efficacy, pharmacodynamics and translational principles for selection of development candidate molecules Translational and Biomarker studies: Facilitate project transitions to Clinical Development in close collaboration with discovery, translational and clinical scientists Flexibility: Must be able to contribute to a portfolio of projects spanning early and late preclinical discovery, translational medicine, and clinical development Communication: Play a key role in representing data, interpretations and nonclinical plans for molecules in our pipeline to external parties
External website https://www.stem-sourcing.com
Contact email address: maya.skolnik@zymeworks.com - 14th Jun 202 [3057]
Zymeworks has a few PK/PD job openings - both in Seattle, Washington, US, and/or Vancouver BC, Canada. We are primarily focused on bispecific antibody (+ADC) therapies. Our lead candidate is in pivotal trials for biliary tract cancer.
Associate Director, Clinical Pharmacology: https://app.jobvite.com/j?cj=otxMffwL&s=Boomer_PK/PD
Scientist/Sr. Scientist/Principal Sci -PK/PD Modeler: https://app.jobvite.com/j?cj=od5tffwK&s=Boomer_PK/PD
SAS Statistical Programmer: https://app.jobvite.com/j?cj=owvsffws&s=Boomer_PK/PD
Feel free to email me directly with questions.
Thank you,
Maya
External website https://www.zymeworks.com/
9th Jun 202 [3056]
Vir Biotechnology logo SENIOR SCIENTIST, CLINICAL PHARMACOLOGY SAN FRANCISCO, CA /TRANSLATIONAL CLINICAL DEVELOPMENT - PHARMACOLOGY /FULL TIME
Vir is a clinical-stage immunology company with a compelling mission: A World Without Infectious Disease. We are focused on combining immunologic insights with cutting-edge technologies. We have assembled four technology platforms that are designed to stimulate and enhance the immune system by exploiting critical observations of natural immune processes. Our current development pipeline consists of product candidates targeting COVID-19, hepatitis B virus, influenza A and human immunodeficiency virus.
We believe the success of our colleagues drives the success of our Mission. We have an ongoing commitment to creating a company passionate about equality, inclusion, and respect. When everyone feels supported and encouraged to give at their best, we will collectively deliver outstanding results.
Vir Bio is seeking a Clinical Pharmacologist to support of all phases of drug development from early clinical development, market application, and commercialization.
RESPONSIBILITIES AND LEARNING OPPORTUNITIES:
The candidate is responsible for clinical PK and/or PK/PD study design, analysis, interpretation, operation, and reporting to support clinical development and international regulatory submissions (e.g., clinical protocols and reports, IB, IND, NDA/BLA). This candidate will have broad responsibilities within the department designing, operationalizing, and analyzing data from clinical studies that evaluate the ADME, safety, and/or efficacy of drug candidates. Additional responsibilities include presenting clinical pharmacology data, acting as a technical specialist on project sub-teams. Understanding and ability to guide quantitative/modeling efforts are also desirable.
QUALIFICATIONS AND EXPERIENCE:
PhD, PharmD, or MD with relevant training in Clinical Pharmacology, pharmacokinetics, pharmaceutics, or related field with 3+ years of experience working in Clinical Pharmacology preferred. Familiarity with the drug development process and the role of Clinical Pharmacology Candidate with experience in designing and facilitating operation and reporting of various Phase 1 studies and Phase 2/3 studies with respect to dose selection/justification, advanced analysis of demographic and disease characteristics (i.e., PK/PD) is preferred Ability to translate preclinical data into clinical dosing schemes, including projection of PK in humans Experience independently developing and/or guiding development of PK and PK/PD models Must be operational on analysis and graphing software (e.g., Phoenix WNL, GraphPad, etc.)
Vir’s compensation and benefits are aligned with the current market and commensurate with the person’s experience and qualifications. All full-time employees receive a package that includes: compensation, bonus and equity as well as many other Vir benefits and perks such as: health, dental, vision, life and disability insurance benefits, non-accrual paid time off, one Friday a month paid-time off, company shut down for holidays, commuter benefits, child care reimbursement, education reimbursement, 401K match and lunch for all lab essential personnel!
Vir is an equal opportunity employer. We value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, sex, gender, gender expression, sexual orientation, age, marital status, veteran status, or disability status. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform critical job functions, and to receive other benefits and privileges of employment. Please contact Human Resources to request accommodation.
Vir Human Resources leads recruitment and employment for Vir. Unsolicited resumes sent to Vir from recruiters do not constitute any type of relationship between the recruiter and Vir and do not obligate Vir to pay fees should we hire from those resumes. We ask that external recruiters and/or agencies not contact or present candidates directly to our hiring manager or employees.
External website https://jobs.lever.co/vir/ae8e54cd-7224-4505-9343-0689fb165297
Contact email address: daniel.gonzalez@unc.edu - 25th May 202 [3055]
Postdoctoral Fellowship in Pharmacokinetics/Pharmacodynamics
UNC Eshelman School of Pharmacy The University of North Carolina at Chapel Hill
A postdoctoral research associate position is available to work on projects focused on characterizing pharmacokinetics/pharmacodynamics in the pediatric population. The project will involve the use of physiologically-based pharmacokinetic (PBPK) and population pharmacokinetic (PopPK) modeling techniques to characterize the effects of age, obesity, and drug-drug interactions in pediatric patients. Requirements: minimum of a PharmD, MD, or PhD with knowledge of pharmacokinetic/pharmacodynamic analyses. Demonstrated software proficiency (e.g., PK-Sim®, NONMEM®, R) is preferred. Excellent communication skills and the ability to work independently and as a member of an interdisciplinary team are essential.
Interested applicants should submit a letter describing personal goals related to the position, Curriculum Vitae, and three professional references at https://unc.peopleadmin.com/postings/187422.
The University of North Carolina at Chapel Hill is an equal opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to age, color, disability, gender, gender expression, gender identity, genetic information, race, national origin, religion, sex, sexual orientation, or status as a protected veteran.
External website https://unc.peopleadmin.com/postings/187422
Contact email address: daniel.scotcher@manchester.ac.uk - 18th May 202 [3054]
Applications are invited for a Research Associate in Translational Pharmacokinetic Modelling, in the Division of Pharmacy and Optometry, University of Manchester, UK.
You will become a member of the Centre of Applied Pharmacokinetic Research (CAPKR) and be fully involved in a project entitled ‘Establishing a translational physiologically-based pharmacokinetic (PBPK) framework for human aldehyde oxidase (AO).’
You will hold a PhD in a biomedical, pharmaceutical or systems modelling research area, and have a background in quantitative drug metabolism and PBPK modelling. Previous experience in quantitative proteomics and enzyme kinetics experiments, as well as working with industrial partners, would be desirable. Emphasis will be placed on a developing publication record.
Application Closing date: 08 June 2021
External website https://www.jobs.manchester.ac.uk/displayjob.aspx?jobid=20176
Contact email address: valva@cop.ufl.edu - 14th May 202 [3053]
The Center for Pharmacometrics and Systems Pharmacology (CPSP) in the Department of Pharmaceutics (PC) at the University of Florida College of Pharmacy (COP) on the Lake Nona (Orlando) campus invites applications for a Postdoctoral Research Fellow position. The successful applicant will have demonstrated expertise in Computer Science, preferably in the area of biosciences and will join the CPSP to develop state-of-the art integrative multidisciplinary models. Demonstrated experience in machine learning and/or other artificial intelligence tools will be considered as an advantage. The candidate will be working under the joined supervision of Dr. Stephan Schmidt and Dr. Valva Vozmediano.
Minimum requirement: The successful applicant will hold a Ph.D. with training in applied Computer Science. FDLE Criminal Background Check Required.
Preferred Qualifications: The successful applicant will have experience in the area of machine learning or other artificial intelligence tools. Soft skills are essential to team-based research, and in order to provide clear verbal and written communication between, trainees, faculty, and external collaborators. Industry experience is an added attribute for the successful candidate provided that a thorough understanding of drug development and regulatory decision making process is helpful for successfully working in the highly collaborative environment of the Center and its partners.
External website https://careers.insidehighered.com/job/2132725/post-doctoral-associate-73163-/
Contact email address: telder@stem-sourcing.com - 5th May 202 [3052]
Senior Scientist or Associate Director DMPK/Clinical Pharmacology
Our Client is searching for a/n Senior Scientist/Associate Director primarily responsible for providing DMPK and clinical pharmacology expertise. The successful candidate will have expertise in clinical pharmacology and pharmacokinetics with experience managing studies contracted to CRO’s and applying this knowledge to the advancement and selection of drug candidates.
Responsibilities:
- Provide expert PK, and clinical pharmacology to support compound advancement and evaluation
- Clinical Pharmacology: Conducts the analysis, interpretation and reporting of clinical and non-clinical pharmacokinetic data. Helps plan, conducts and reports quantitative analyses to select / optimize doses, dosage regimens throughout clinical drug development
- Regulatory: Manage the preparation and/or presentation of nonclinical pharmacology sections of external documents (e.g. Investigator’s Brochure, IND/ CTA,NDA.)Pharmacometrics: Performs exposure-response and PBPK modeling using a variety of software,
- CRO oversight: delivers critical project data through a network of external study providers. In collaboration with project teams, participate in study design, troubleshooting, data analysis and interpretation, Reviews study reports,
- DMPK: Utilize animal models, define efficacy, pharmacodynamics and translational principles for selection of development candidate molecules
- Translational and Biomarker studies: Facilitate project transitions to Clinical Development in close collaboration with discovery, translational and clinical scientists
- Flexibility: Must be able to contribute to a portfolio of projects spanning early and late preclinical discovery, translational medicine, and clinical development
- Communication: Play a key role in representing data, interpretations and nonclinical plans for molecules in our pipeline to external parties
- Ph.D. in Pharmacology, Biomedical Sciences, Pharmacokinetics or other discipline with appropriate experience
- Strong technical proficiency in PK analysis (NCA)) Experience with PBPK modeling. DDI simulations is a plus.
- Demonstrated small molecule drug discovery experience: track-record of advancing multiple novel therapeutic agents from discovery into clinical development as project team leader or member
- Experience in successfully managing CROs to provide high quality and timely studies
- Strong written and verbal communication skills - ability to clearly and persuasively articulate complex concepts and strategies to a diverse audience
External website https://www.stem-sourcing.com
Contact email address: telder@stem-sourcing.com - 27th Apr 202 [3051]
Sr. Dir. Clinical Pharmacology and Pharmacometrics*****West Coast****
Our Client is seeking an experienced clinical pharmacology leader to work on an aggressive pipeline with over 10 programs in the pipeline many in Phase 1 and Phase 2.
Strong partnerships with large pharma are propelling this company into an exponential growth mode.
Qualifications
Pharmaceutical industrial experiences in the related disciplines of clinical pharmacology, PKPD M&S, and QSP;
Excellent hands-on knowledge in R, S-PLUS and/or SAS, NONMEM;
Excellent knowledge in Matlab, or other QSP related softwares or computing platform;
Well versed at plotting complex data to identify trends important for drug development;
Proven track record of applying quantitative system pharmacology methodologies in a drug R&D context;
Proven track record of contributions to INDs, NDAs/BLAs, and various regulatory submissions;
Excellent track record of publishing M&S work, and a recognized expert in PKPD M&S and PMX field.
External website https://www.stem-sourcing.com
Contact email address: valva@cop.ufl.edu - 26th Apr 202 [3050]
The Center for Pharmacometrics and Systems Pharmacology (CPSP) in the Department of Pharmaceutics (PC) at the University of Florida College of Pharmacy (COP) on the Lake Nona (Orlando) campus invites applications for a Postdoctoral Research Fellow position. The successful applicant will have demonstrated expertise in Computer Science, preferably in the area of biosciences and will join the CPSP to develop state-of-the art integrative multidisciplinary models. Demonstrated experience in machine learning and/or other artificial intelligence tools will be considered as an advantage. The candidate will be working under the joined supervision of Dr. Stephan Schmidt and Dr. Valva Vozmediano.
Minimum requirement: The successful applicant will hold a Ph.D. with training in applied Computer Science. FDLE Criminal Background Check Required.
Preferred Qualifications: The successful applicant will have experience in the area of machine learning or other artificial intelligence tools. Soft skills are essential to team-based research, and in order to provide clear verbal and written communication between, trainees, faculty, and external collaborators. Industry experience is an added attribute for the successful candidate provided that a thorough understanding of drug development and regulatory decision making process is helpful for successfully working in the highly collaborative environment of the Center and its partners.
External website https://careers.insidehighered.com/job/2132725/post-doctoral-associate-73163-/
Contact email address: junjie.ding@astrazeneca.com - 16th Apr 202 [3048]
Clinical Pharmacology (CP) team in AstraZeneca R&D China is looking for several highly motivated clinical pharmacologists from principal scientist to associate director level. CP team is responsible for all aspects of clinical pharmacology-related support for small molecules and biopharmaceutical products at various stages of clinical development.
This position serving as a senior member of the CP team to provide strategic and scientific CP support for clinical development programs in multiple therapeutic areas (TA), interacting with regional and global project teams as well as senior management.
If you are interested in this position, please email your resume to Junjie Ding (junjie.ding@astrazeneca.com) and Daphel Li (daphel.li@astrazeneca.com)
DUTIES & RESPONSIBILITES
Provide CP expertise and leadership in clinical development programs, including:
- Design and conduct clinical studies including CP studies (dosing rationales, sampling schemes, etc.)
- Data analyses (e.g., M&S) to elucidate dose-exposure-response relationships, and result interpretations
- Preparation and defence of regulatory submissions
- Compile and contribute to sections of drug development and registration documents such as clinical trial protocols and reports, drug package inserts and regulatory submission packages, etc.
- Interact with internal and external stake holders for assigned projects:
- Serve as a China liaison with Global CP
- Serves as core member of the China Project Team
- Interact with investigators for scientific issues
- Responsible for delivering quantitative pharmacology and M&S supports to clinical development projects:
- Play a central role in predicting human dose range, characterizing dose-exposure-response relationship, justifying dose recommendations for special populations, and evaluating ethnic sensitivity
- Develop mathematical and statistical models to understand disease mechanism, its progression, and PK/PD; conduct meta-analyses as appropriate to maximize data use
- Train junior CP staff
- Support establishing best practices for CP activities (e.g., M&S)
- Evaluate in-licensing opportunities for clinical PK and PK/PD components when needed
- Literature research and knowledge sharing
- Ph.D/PharmD/MD in relevant disciplines (CP, pharmacokinetics (PK), pharmacometrics) or other equivalent degrees or knowledge/expertise
- 3+ years of relevant industry experience in CP and Modeling & Simulation (M&S) role
- Early and late phase clinical development experience
- Proven track records and skills in PK, Pharmacodynamics (PD) and longitudinal disease modelling; and proficiency in pharmacometric tools (e.g., NONMEM, R, Monolix, etc.)
- Adequate understanding of related disciplines (e.g., DMPK, toxicology, biostatistics, medical, regulatory) in drug development
- Excellent communication and negotiating skills
- Ability to function effectively in a highly cross-functional team and dynamic environment
- Fluent in English (oral and written)
- Team working spirit with self-motivation
6th Apr 202 [3047]
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 39,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.For more than a century, Eli Lilly and Company has been committed to making life better. At Lilly, we continuously focus on new and innovative ways to fulfill our extraordinary purpose of making medicines that help people live longer, healthier, more active lives. Our goal is to add to our diverse team of scientists a teammate passionate about improving the lives of people around the globe. Passion, curiosity, creativity, and persistence are qualities of our research area. We strive to affect change and deliver results. Do you have the scientific and technical expertise to influence and apply model-informed drug discovery and development? Confident and compelling communication will be key in this role.
The Global Pharmacokinetics/Pharmacodynamics and Pharmacometrics Department at Lilly is looking for creative, motivated and hardworking scientists to join our group. The scientists in our group are functional leaders in research and development throughout the value chain from preclinical lead molecule identification to clinical post-drug approval. Optimally identifying and developing the right drug with the right dose for the right patient and living the model-informed drug research and development (MIDD) paradigm is the goal.
Our organization seeks a multifaceted, experienced, and driven scientist who is able to:
- Provide PK/PD/Pharmacometric and scientific leadership to project teams to support the selection of the right target, molecule, dose, patient population, and development strategies; apply the appropriate PK/PD and pharmacometric approaches to translate from preclinical to the clinical setting by integrating data from multiple fields.
- Expect and understand the high-level issues affecting the drug discovery/development process and help derive at effective solutions. Support decision-making through collaboration on cross-functional teams.
- Develop PK/PD sections of program and product team plans/strategies as project leader.
- Lead and support the preparation and delivery of Phase I, II, and III study protocols, analysis plans, data analysis and interpretation, and study reports.
- Responsible for preparation of relevant INDs, IBs, CTDs and other regulatory documents for development and registration of new drugs and line extensions across multiple geographies. This may involve direct interaction with FDA, EMA, PMDA and other regulatory agencies.
- Mentor other scientists within the department and in other areas as well as interact, teach and collaborate with academia.
- Represent the group to increase visibility externally, through key publications, active leadership in key scientific organizations, industry trade groups, or consortia
Basic Qualifications:
- PhD and/or MD in relevant scientific area such as biological/pharmaceutical sciences, bioengineering or related field.
- At least 5 years of experience from industry, regulatory, consulting or academia with exposure to industry.
- Excellent understanding of clinical pharmacology (PK, PD and pharmacometrics) principles.
Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
To submit resume, visit https://www.lilly.com/careers and apply to Req ID R-11720.
Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
External website https://careers.lilly.com/job/indianapolis/principle-research-scientist-pk-pd-and-pharmacometrics/41
Contact email address: telder@stem-sourcing.com - 29th Mar 202 [3046]
DMPK Scientist
Our Client is seeking a highly motivated and team-oriented candidate for the position of Scientist in the Drug Metabolism and Pharmacokinetics (DMPK) Department. The successful applicant will lead the development, validation, and application of cell based in vitro ADME assays to support our discovery and development programs. Reporting directly to the Senior Director of Clin Pharm, this is a unique opportunity to take on a role with a broad range of responsibilities and work in DMPK and Clinical Pharmacology.
Core responsibilities:
Utilize animal models, define efficacy, pharmacodynamics and translational principles for selection of development candidate molecules
Conducts the analysis, interpretation and reporting of clinical and non-clinical pharmacokinetic data. Helps plan, conducts and reports quantitative analyses to select / optimize doses, dosage regimens throughout clinical drug development
Experience with Simcyp, Monolix, Phoenix Winnonlin or other modeling software. PBPK experience and experience with DDI
Qualifications:
Must have 2+ years of experience in the pharma/ biotechnology industry or Post Doc.
Ph.D./PharmD in Pharmacology, Biomedical Sciences, Pharmacokinetics or other discipline with appropriate experience
Strong, demonstrable track record of scientific leadership excellence
Demonstrated small molecule drug discovery experience: track-record of advancing multiple novel therapeutic agents from discovery into preclinical and subsequent clinical development as project team leader or member
Experience in successfully selecting and managing CROs to provide high quality, timely and on-budget studies
External website https://www.stem-sourcing.com
Contact email address: broseberry@cartermackay.com - 25th Feb 202 [3045]
Please see below role and let me know if interested or have a referral. Position is with an established pharma client. Full time, salary, benefits. Location is MA but can also be remote/WFH with some minimal travel to meet with direct reports from time to time post covid shutdowns.
Senior Director, Head of Pharmacometrics
Position Summary
The Head of Pharmacometrics will be reporting to the Senior Vice President of Clinical Pharmacology and Pharmacometrics. In this position, the head of pharmacometrics is expected to provide strong technical and strategic leadership to a group of talented pharmacometricians and, strengthen and champion quantitative model based drug development across the organization. Will be responsible for pharmacometrics plan, conduct and review of modeling analysis for internal decision making and regulatory filings. Candidate should possess scientific curiosity and a passion for quantitative science based interrogation of data.
Major Duties and Responsibilities
- Strategize, formulate and execute on modeling and simulation strategy for clinical projects with ability to independently plan, design, analyze, interpret and report PKPD modeling results for internal decision making and regulatory filings
- Train, mentor and grow pharmacometrics team members in modeling and simulation skills.
- Responsible for identification of dosing regimen and optimization of dosing for products
- Collaborate and influence decision making pertaining to dosing and clinical trial design on project teams
- Strategize, collaborate cross-functionally with other departments and provide modeling and simulation support
- Formulate pharmacometric strategy and responses to regulatory health authority inquiries on PK, PK/PD, dosing and clinical pharmacology related issues. Represent pharmacometrics at regulatory meetings.
- Enhance role and visibility of pharmacometrics internally within the company and showcase expertise through publications in peer reviewed journals and presentations at scientific meetings
- Candidate with a Ph.D (or equivalent) degree in pharmacokinetics, biopharmaceutics or related field
- At least 10 years of pharmacometrics experience in pharmaceutical industry or regulatory agency. Should have hands-on experience and an expert in NONMEM, S-plus, R-, SAS and WinNonlin and should be intimately familiar with the drug development process. Be a team player and a strong cross-functional contributor and partner.
- Candidate should possess good understanding of pharmacokinetic and pharmacodynamic principles and have extensive experience in quantitative population PK/PD modeling and simulation using NONMEM
- Candidate should have experience in clinical endpoint, disease progression and mechanistic modeling
- Strong managerial skills with proven record of mentoring and advancing a pharmacometric group
- Candidate should have experience writing clinical pharmacology sections of NDA/MAA and preparation of pharmacometric reports to support regulatory filings
- Strong written and oral communication skills
- Team player with strong interpersonal skills
- Ability to strategize, influence, advance and implement model based drug development. Formulate strategy and engage with regulatory authorities on development proposals particularly around dose selection. Showcase value of modeling and simulation through informed decision making.
- Independent contributor who is able to multi-task and prioritize with minimal supervision. Provide mentoring, strategic and planning support and train pharmacometrics team members in advanced pharmacometric skills. Motivated to promote role of pharmacometrics across the company in a personable, result-oriented and collaborative manner.
Contact email address: telder@stem-sourcing.com - 24th Feb 202 [3044]
DMPK Scientist
Position & Responsibilities: Our Client is seeking a DMPK Scientist experienced in structural elucidation of oligonucleotides and small molecules by applying analytical techniques including mass spectrometry. S/He will be joining a team of highly motivated and experienced chemists and biologists and contribute to the success of the organization. S/He will be expected to:
- Design and execute metabolite profiling and identification from in vitro and in vivo samples of various matrices
- Interpretation of metabolic profiles and structural elucidation based on established biotransformation pathways
- Develop and execute other IND-enabling in vitro ADME assays (e.g., metabolic stability, plasma protein binding, gel electrophoresis)
- Support LC-MS instruments daily operation, maintenance, and trouble shooting
- Presentation of detailed results to project teams
Required:
- PhD (or work experience equivalent) in Biochemistry, Pharmaceutical Science, or a related discipline with > 3 years of industry experience
- Experience with sample preparation and extraction methods.
- Deep expertise in metabolite profiling and identification, including HRMS instrumentation and technologies
- Knowledge of nucleotide drug detection, quantitation and biotransformation desired
- Direct hands-on experience and strong trouble shooting skills with in vitro assays, in vivo studies, and various LC-MS platforms
- A strong track record of accomplishments with excellent interpersonal, verbal and written communication skills
External website https://www.stem-sourcing.com
Contact email address: broseberry@cartermackay.com - 17th Feb 202 [3043]
Associate Director Clinical Pharmacology, NJ
please contract me at broseberry@cartermackay.com for more info.
New Associate Director role available with pharma client in NJ. Please email me at broseberry@cartermackay.com for more info
The Associate Director, Clinical Pharmacology position will support the clinical pharmacology programs for an expanding portfolio of products across several disease areas. This role will independently execute routine clinical pharmacology tasks with minimum supervision and may include oversight of vendors and/or contractors.
Responsibilities:
- Represent Clinical Pharmacology and provide PKPD support.
- Lead the analysis, interpretation, integration and reporting of clinical pharmacokinetic & pharmacodynamic data
- Conduct PK/PD analyses to guide development decisions on project teams
- Provide PKPD input for regulatory submissions such as briefing documents, IND, CTA and NDA
- Prepare appropriate documents or sections of clinical protocols, Investigator Brochures, Clinical Study Reports with respect to Clinical Pharmacology studies or data
- Preparation of abstracts and manuscripts for publication
- Closely partner with Research, Clinical functions, Regulatory, Project Management, and other R&D functions.
- PhD in Pharmacokinetics,
- Pharmacology, Pharmaceutics or another relevant field or M.D. or PharmD with equivalent experience
- Minimum of 5 years of experience in the pharmaceutical industry
- Solid working knowledge of pharmacokinetics and modeling, PKPD principles, ADME concepts, and clinical pharmacology
- Working knowledge of pharmacokinetic, modeling and data visualizations software
- Strong communication skills (verbal and written) and presentation skills are required
- Excellent interpersonal skills and the ability to function in a highly matrixed team environment are essential
2nd Feb 202 [3042]
Organization Overview:
At Lilly, we serve an extraordinary purpose. We make a difference for people around the global by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.
For more than a century, Eli Lilly and Company has been committed to making life better for our patients and communities. At Lilly, we continuously focus on new and innovative ways to fulfill our extraordinary purpose. Our goal is to add to our diverse team of scientists a teammate passionate about improving the lives of people around the globe. Passion, curiosity, creativity, and persistence are qualities of our research teams. We strive to affect change and deliver results. Do you have the scientific and technical expertise to influence and apply model-informed drug discovery and development? We need you on our team!
Responsibilities:
This is an exciting role responsible for applying quantitative models to the discovery and development of therapeutic drug candidates. We are seeking a modeling and simulation scientist to contribute in a collaborative environment as we use diverse analytical and computational tools to characterize factors influencing the pharmacokinetic and pharmacodynamic properties of a diverse range of therapeutic modalities.
You will have the opportunity to:
- Function as a project leader in a multidisciplinary team environment
- Integrate pharmacokinetics and PK/PD with discovery biology to define structure activity relationships guiding engineering strategies and optimization of therapeutics
- Design, conduct, analyze and interpret PK/PD studies
- Communicate scientific data, both internally and in the scientific community
- Ph.D. in Pharmacokinetics/Pharmacodynamics or a related field
- Experience in PK/PD or PBPK modeling preferred
- Understanding of how to apply mathematical models to drug discovery/development
- Experience using relevant software such as WinNonlin, NONMEM, R, SimCYP or MATLAB
- Industry (pharma, biotech, CRO, etc.) experience with PK/PD or PBPK modeling
- Understanding of bioanalytical and in vitro assays used in drug development
- Prior experience working in an interdisciplinary team.
External website https://careers.lilly.com/job/indianapolis/research-scientist-modeling-and-simulation/410/18580266
27th Jan 202 [3041]
Postdoctoral Fellowship in Pharmacokinetics/Pharmacodynamics
UNC Eshelman School of Pharmacy The University of North Carolina at Chapel Hill
A postdoctoral research associate position is available to work on projects focused on characterizing pharmacokinetics/pharmacodynamics in the pediatric population. The project will involve the use of physiologically-based pharmacokinetic (PBPK) and population pharmacokinetic (PopPK) modeling techniques to characterize the effects of age, obesity, and drug-drug interactions in pediatric patients. Requirements: minimum of a PharmD, MD, or PhD with knowledge of pharmacokinetic/pharmacodynamic analyses. Demonstrated software proficiency (e.g., PK-Sim®, NONMEM®, R) is preferred. Excellent communication skills and the ability to work independently and as a member of an interdisciplinary team are essential.
Interested applicants should submit a letter describing personal goals related to the position, Curriculum Vitae, and three professional references at https://unc.peopleadmin.com/postings/187422.
The University of North Carolina at Chapel Hill is an equal opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to age, color, disability, gender, gender expression, gender identity, genetic information, race, national origin, religion, sex, sexual orientation, or status as a protected veteran.
External website https://unc.peopleadmin.com/postings/187422