Merck KGaA is currently looking for a Project representative Development NCE DMPK (all genders), based in Darmstadt (Germany)
Your role:
We are seeking an experienced Project Representative to join our Development NCE DMPK team in Darmstadt (GE).
The Project Representative, New Chemical Entities (NCE) DMPK is a strategic and scientific role within Discovery and Development Technologies (DDTech) in Research and Development (R&D).
You will be DMPK representative in project teams/subteams, ensuring that the proper flow of information between the project, the function, and key stakeholders is in place. You will support projects from early development to life cycle management, fulfilling internal and regulatory requirements. As project representative, you will identify DMPK related key issues, define the appropriate project plan, and ensure that studies are conducted on time and with the required quality. You will analyze and interpret in vitro/in vivo DMPK data, provide the project team on risk assessment and issue management, and contribute to clinical study protocol development.
Who you are:
- PhD in Drug Metabolism, Pharmacokinetics, Chemistry or related fields with 5-10 years of industrial experience in DMPK, Clinical Pharmacology or related fields.
- Have a proven record of in-depth knowledge of DMPK science and its application in drug development
- Profound knowledge of regulatory guidelines and experience in the preparation of regulatory documents Team player with strong communication skills in a multicultural environment
- Experience in Oncology and Immunology would be a plus Highly flexible and creative with a strong sense of responsibility
- Excellent knowledge of spoken and written English.
External website https://career5.successfactors.eu/sfcareer/jobreqcareer?jobId=209042&company=merckgroup
Contact email address: broseberry@cartermackay.com - 16th Sep 202 [3017]
Sr. Scientist/Associate Director role in Pharmacometrics in NJ. Level pursuant to individual experience. Please email me for more info at broseberry@cartermackay.com
This individual will contribute to the pharmacometrics strategy. This role requires a strong and pharmacokinetics/pharmacodynamics/pharmacometrics knowledge, with hands on modelling and simulation skills, and will work in close collaboration with various internal functions. This role may also be able to supervise more junior-level Pharmacometricians and will also assist in interactions with senior-level external partners and consultants.
Job Responsibilities
- Lead the implementation of model-based drug development strategies for assigned preclinical, clinical, and lifecycle management projects
- Execute relevant pharmacometric analyses: non-compartmental PK, PK/PD analyses, population PK and PK/PD, clinical trial simulations, meta-analyses, disease and systems biology modelling, and other modeling and simulation activities as appropriate for the project.
- Apply analytical methods in pharmacometrics to integrate knowledge of pharmacokinetics, pharmacodynamics, patient characteristics and disease progressions in support of optimal study designs
- Provide pharmacometrics contributions to regulatory documents including Investigator Brochures, Labeling and those required for regulatory meetings and regulatory filings. Provides resolution of pharmacometrics queries from regulatory agencies, taking a lead role in writing and reviewing responses to regulatory queries
- Write Modeling & Simulation Analysis Plans and Reports. - Analyze and interpret all study PK, PK/PD and pharmacometric outcomes. Ability to create PK/PD files according to standard specifications and to generate tables and listings as required
- Develop external alliances with partners, consultants, contract organizations and academic institutions to ensure timely conduct of all pharmacometrics deliverables for projects with high quality and development of junior colleagues in the discipline
- If hired at the AD level, Associate Directors will act as a mentor to junior pharmacometricians, providing strategic and technical guidance for their activities.
- A Ph.D. or equivalent degree with at least 3 years of experience OR a PharmD or equivalent degree with at least 5 years of experience OR an MS or equivalent degree with at least 8 years of experience, where experience means having a proven track record within the duties mentioned above in pharmaceutical industry, regulatory agency, or academia. Required Experience and Skills
- Educational background in pharmacometrics, clinical Pharmacology, biopharmaceutics, pharmaceutical sciences, mathematics, statistics/biostatistics, computational biology, biomedical engineering, or a related field.
- Proficiency in NONMEM, R or other similar programing language Preferred Experience and Skills
- In-depth knowledge and experience in performing population PK, PK/PD analyses using pharmacometrics software such as NONMEM, Phoenix, Monolix, R, SAS, etc.
- Advanced pharmacometrics knowledge in one of the following core sub-area: advanced Exposure-Response Models, Disease Models, Physiological-Based Pharmacokinetic Models, Quantitative Systems Pharmacology
- Experience leading and implementing all aspects of pharmacometrics needs across a variety of disease areas
8th Sep 202 [3016]
Nuvisan Pharma Services is looking for DMPK experts as DMPK expert, team lead, lab-head or laboratory scientist in all fields of DMPK, biotransformation, in vitro PK and in vivo ADME, for our sites in Grafing near Munich and Berlin. Check out our career site and learn more about the current job openings.....and more job positions to come.
We hope to welcome you soon!
External website https://nuvisan.odoo.com/jobs
Contact email address: kapraun.dustin@epa.gov - 1st Sep 202 [3015]
The Chemical Pollutant Assessment Division (CPAD) at the U.S. EPA's Center for Public Health and Environmental Assessment (CPHEA) is looking to hire a staff scientist with quantitative modeling expertise. We would like to find a candidate with knowledge of and experience with PBPK modeling. View the full position description and apply on USAJobs!
https://www.usajobs.gov/Search/Results?k=RTP-ORD-DE-2020-0090
Applications will be accepted through 9/8/2020.
External website https://www.usajobs.gov/Search/Results?k=RTP-ORD-DE-2020-0090
Contact email address: telder@stem-sourcing.com - 28th Aug 202 [3014]
Principal Scientist/Associate Director level DMPK Modeling and Simulations Role
Our Client in the Boston area is looking for a strong PhD level scientist to deliver mechanistic and quantitative PK/PD/efficacy relationships to support project teams from early discovery through early clinical development. In addition, the individual will be involved in (PK) and (ADME) studies of to support drug development from early discovery through preclinical and clinical development. The individual will serve as DMPK project representative to coordinate and lead all nonclinical DMPK activities on programs from research phase through development. An individual with in-depth knowledge and expertise in PK/PD modeling and simulation and ADME is essential. Responsibilities: Provide quantitative and mechanistic PK/PD/efficacy relationships to support drug discovery and development teams Design/execute preclinical studies to understand the (PK) and (ADME) of drug candidates Represent DMPK as the subject matter expert on project teams, develop and drive DMPK and PK/PD strategy for Drug Discovery projects Participate and manage CROs in the conduct of in vitro/in vivo ADME studies Qualifications PhD. with years of experience in the biopharmaceutical industry, with evidence of modeling experience Fluency with simulations and modeling, and in depth hands-on modeling experience (e.g. using WinNonlin Phoenix, MATLAB/Simbiology, PK Sim, Simcyp, or NONMEM to develop PK/PD models) Solid knowledge of metabolism, ADM, PK/PD and bioanalytical principles is required. Experience with biologics desirable but not required. Strong communication and presentation skills required Excellent interpersonal skillsExternal website https://www.stem-sourcing.com
Contact email address: anthony.cunningham@duke.edu - 21st Aug 202 [3013]
Duke Clinical Research (DCRI) is seeking a pharmacometrician to join one of the world’s leading academic clinical research organizations. The Pharmacometric Center of Excellence has a strong history of both industry and government funding and combines thought leadership from clinical subspecialists with unique expertise in regulatory submissions and clinical pharmacology in special populations (e.g., children, pregnancy). The candidate will join a multidisciplinary team of clinical research professionals in a position that combines flexible working arrangements, cross-disciplinary mentorship, opportunities for publication, and room for personal growth and career advancement.
The ideal candidate will join cross-disciplinary study teams leading multicenter clinical trials across therapeutic areas conducted to support regulatory submissions to the US Food and Drug Administration and other agencies. As a member of the study teams, the pharmacometrician will provide scientific expertise in clinical pharmacokinetics to support study protocol development and analysis planning, perform pharmacokinetic (PK) and pharmacodynamic (PD) analyses, and prepare reports and integrated summary documents. Through this role, the pharmacometrician will have extensive interactions with scientific and clinical experts, operational leaders, and regulatory scientists to expand their knowledge base and expertise in regulatory compliant clinical trials. Results of analyses and trials will be disseminated via peer reviewed publications and presentations at national and international meetings, with ample opportunities for the pharmacometrician to author and lead author publications.
Work Performed Application of PK/PD techniques during all stages of drug development, including molecule selection, non-clinical dose and regimen selection, first-in-human studies, Phase II dose/regimen selection, and strategic and tactical decision-making for large Phase III clinical studies. There will be a focus on the evaluation and implementation of innovative trial designs to enhance the efficiency and provide better informed decision-making. Evaluation and understanding of PK/PD characteristics absorption, distribution, metabolism, and excretion (ADME) research on compounds, and associated variability of drugs in clinical development, using empiric, mechanistic, and population modeling approaches.
Education/Training: Work requires a minimum of a PharmD, MD, PhD in pharmaceutical sciences or pharmacology. Graduation from an accredited postdoctoral clinical pharmacology program. Or an equivalent combination of relevant education and/or experience.
Experience: Proficient in PK/PD or related analyses and extensive knowledge of and hands-on familiarity with software such as winnonlin and NONMEM software required. Ability to assemble and format data using programs such as R, SAS, Stata is a plus.
External website https://dcri.org
Contact email address: telder@stem-sourcing.com - 10th Aug 202 [3012]
Our client is searching for an experienced Senior Director, Clinical Pharmacology to serve as the area leader for Clinical Pharmacology and report to the Vice President, Head of Translational Medicine. The Senior Director will also manage the scientific functions and coordinate the activities of the Clinical Pharmacology division of Translational Medicine in collaboration with the other Disease Area leaders. The Senior Director’s responsibilities will include maintaining organizational processes across the group, influencing clinical program strategy, and integrating activities with other departments across the Global Research and Development organization, to help shape innovative and integrated clinical development plans. As the Disease Area leader for Pain and Neurology programs, the Senior Director will also direct Clinical Pharmacology efforts for small molecule and novel modality programs, such as gene editing, gene therapy, and cell therapy, in the Disease Area.
Key Responsibilities:
Manage a group of Clinical Pharmacologists at Director-level and below to set strategy, develop and execute Clinical Pharmacology plans and studies for Pain and Neurology programs
Manage department resources and sets priorities among competing projects and demands while communicating and negotiating the priorities
Support career development and management training for junior staff
External website https://www.stem-sourcing.com
Contact email address: broseberry@cartermackay.com - 30th Jul 202 [3011]
New roles available, bay area CA, level flexible. Relo provided, also flexible during COVID.
This position will assist in developing and applying clinical pharmacology and translational medicine strategies for candidate drug products including from FIH through late stage development and regulatory filing using PK, PD, DMPK, and drug therapeutic principles, and knowledge of drug development processes and regulatory guidance.
- Represent clinical pharmacology on cross-functional project teams involved in the clinical development of candidate drug products.
- Collaborate with biostatisticians, clinicians and clinical operation managers for the optimal design of Phase I-IV studies; contribute to the clinical study protocols and reports.
- Work closely with sample management and bioanalytical.
- Assist in integrating and interpreting nonclinical and clinical pharmacology, DMPK, and translational medicine knowledge; in the preparation of clinical pharmacology write-ups and regulatory documents (IND, IMPD, IB, NDA CTD, etc).
- Create and manage of datasets and tasks such as non-compartmental and compartmental PK/PD analysis.
- Collaborate with pharmacometricians in the modeling of emerging PK and PK/PD data.
- Participate in writing publications and making scientific presentations consistent with development strategies.
- Maintain knowledge of relevant scientific and regulatory practices and trends, and ensure that clinical pharmacology aspects of development programs are contemporary. Other duties as assigned.
Contact email address: broseberry@cartermackay.com - 29th Jul 202 [3010]
New role available! Full time, level flexible. Can work remotely to start. email me for more info:
Sr. Scientist/Manager/Associate Director Quantitative Clinical Pharmacology
responsible for providing quantitative clinical pharmacology and pharmacometric deliverables for clinical development assets from phase I-III. The individual will prepare and develop clinical pharmacology plans including dose selections and predictions using mathematical and statistical models to study complex interactions between drugs, patients, and biological systems to understand disease progression and the impact of patient stratification on disease progression.
Primary Responsibilities Include:
- Perform advanced quantitative pharmacology and pharmacometric analyses and activities within assigned programs to yield high value PK/PD support for critical decisions and dose selection; interprets and presents results and recommends appropriate actions.
- Manage and develop clinical pharmacology efforts such as study designs, protocol preparation, data analysis and reporting.
- Supports the development and execution of the quantitative pharmacology strategy of clinical development teams.
- Provide insightful regulatory strategy for clinical pharmacology and modeling support of drug filings and is responsible for the respective sections of regulatory documents.
- Develop and maintain strong knowledge of best regulatory practices, clinical pharmacology principles, PK/PD analysis methodology and drug development precedent.
- Develop and maintain scientific awareness and presence in the clinical pharmacology and pharmacometric discipline, publishes manuscripts and posters, presents at scientific conferences and other scientific forums.
- Perform other related duties as assigned.
- PhD degree in Pharmacokinetics-Pharmacodynamics, Pharmacometrics, biomedical engineering, statistics, applied mathematics, or a related field
- Experience in developing advanced quantitative system in Pharmacometrics, PK/PD, PBPK models to aid in research and development decision making.
- Knowledge of Health Authority perspective on use of modeling and simulation.
- Excellent interpersonal, collaboration, English communication skills (both written and verbal).
- Strong analytical skills and strategic thinking.
- Proven ability to successfully manage projects and timelines, organize/track complex information, prioritize accordingly, and the ability to quickly adjust to shifting priorities and demanding timelines when necessary.
Contact email address: telder@stem-sourcing.com - 28th Jul 202 [3009]
The Director level clinical pharmacologist/pharmacokineticist in the Department of Translational Medicine and Early Stage Clinical Development plays a central role in both clinical development and in support of nonclinical development. He/she will represent Clinical Pharmacology function and provide subject matter expertise on cross-functional project teams. He/she will assist in directing the clinical pharmacology development plan, synopsis preparation, clinical phase oversight, and reporting, and provide leadership of a multifunctional study team focused on clinical studies through design, delivery, and reporting, as well as ensuring scientific accountability. He/she will mentor junior and senior level scientists in the department in addition to being an individual contributor.
A core scientific responsibility is ensuring optimal doses and dosage regimens in patients, and as such, the successful candidate must be able to integrate the knowledge of PK/PD, quantitative modeling and simulation, drug development, TK, and nonclinical PK (ADME and DMPK). Working within the clinical development organization, the Director role supports multiple programs through participation on internal project working teams and serves as a liaison between chemistry, life sciences, regulatory and clinical operations.
Essential Areas of Responsibility: The incumbent may design, conduct and/or manage internal and external IND-enabling studies (eg: in vitro and in vivo nonclinical metabolism and PK), design and review clinical pharmacology study protocols and support clinical trials, conduct pharmacokinetic/pharmacodynamic modeling and analyses, and incorporate findings into study report and regulatory documents as well as participate directly in regulatory interactions. A strong background in clinical pharmacology and pharmacokinetics combined with excellent leadership and communications skills are essential in this dynamic role. Clinical pharmacology experience with both small and large molecules in a variety of clinical investigation paradigms (eg: adaptive trial design) is desired. Direct experience with pharmacokinetic/pharmacodynamic modeling, bioanalytical analysis, and nonclinical ADME are desirable attributes. Knowledge of, and immediate experience in the area of CNS and/or oncology therapeutics is desired.
The candidate is expected to be an active contributor to the multi-disciplinary project teams, providing innovative and progressive thinking to projects and where appropriate guidance to other team members. Upon completion of on-boarding, this person will be relied upon to act independently, within a highly matrixed clinical development organization and must have the experience and conviction to provide sound clinical pharmacology related input to the project teams.
Minimum Education & Experience Requirements:
- Ph.D. or Pharm D in Pharmaceutical Sciences, Pharmacometrics, or related field with 10+ years of experience in pharmaceutical industry. Demonstrated experience in serving as clinical pharmacology lead on development programs.
- Experience in non-compartment and model-based PK and PK/PD analyses and inclusion of data in the preparation of manuscripts, study reports and sections of regulatory submission documents (eg: INDs, NDAs, CTDs) is required.
- The incumbent should have a strong understanding of pharmacokinetic theory, compartmental modeling and simulation, and statistical approaches utilizing the latest computational approaches and tools
- Hands-on experience in utilizing WinNonLin, NONMEM and/or other modeling software is required. Experience with population PK, mechanistic PK-PD modeling/systems pharmacology and PBPK modeling is a plus. Familiarity with statistical approaches and programs for data analysis.
- Scientific writing and presentation skills are essential; peer reviewed publications in a relevant field required.
- Current knowledge of FDA regulatory guidance related to nonclinical and clinical pharmacology; experience having direct interaction with FDA, including submission of IND, NDA and other regulatory documents is required.
- Understanding of, and compliance with, regulatory, protocol, standard operating procedures, and Good Laboratory Practices (GLP) and Good Clinical Practices (GCP) as appropriate.
- Excellent interpersonal, leadership, communication and time-management skills are essential; demonstrated direct management of internal and external personnel (outsourced projects) is required.
External website https://www.stem-sourcing.com
Contact email address: cornelia.boehnstedt@fu-berlin.de - 16th Jul 202 [3008]
Call for applications within the interdisciplinary PhD program PharMetrX
The Graduate Research Training Program PharMetrX: Pharmacometrics & 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 & 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 & Network) offers a specifically tailored training program of compact modules that convey the foundations in pharmacokinetics & pharmacodynamics, systems biology, statistics, methodological approaches of modelling & 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 2020.
PharMetrX is a joint program of Freie Universität Berlin and the Universität Potsdam, supported by a consortium of global research-driven pharmaceutical companies.
Charlotte Kloft & Wilhelm Huisinga Program Chairs
External website https://www.PharMetrx.de
Contact email address: Filippos.Kesisoglou@Merck.com - 30th Jun 202 [3007]
Senior Scientist - Biopharmaceutics, Pharmacokinetics
Please see link here:
https://jobs.merck.com/us/en/job/R60517/Senior-Scientist-Biopharmaceut
Our team is looking for a strong candidate for the position of Senior Scientist to support biopharmaceutics assessment across delivery modalities. The successful candidate will be responsible for representing the biopharmaceutics team in drug product development teams, driving the biopharmaceutics strategy, while helping to develop the next generations of physiologically-based modeling and simulation tools.
Primary Responsibilities:
Proactively identifying key biopharmaceutics risks at each stage of drug product development, conducting hypothesis-based assessment employing an integrated approach, driving the development of in vitro-in vivo relationship and preclinical-to-clinical translation in bioperformance of formulations.
Developing physiologically-based pharmacokinetic models to facilitate decisions in areas including formulation development, food effect evaluation, in vitro-in vivo correlations and dissolution specification setting.
Leading and participating in both internal and external innovation in the fields of biopharmaceutics and modeling.
Education Minimum Requirements:
PhD in Pharmaceutics, Pharmacokinetics or Pharmaceutical Sciences
Masters in Pharmaceutics, Pharmacokinetics or Pharmaceutical Sciences with at least 5 years of industry experience.
Required Experience and Skills:
Advanced coursework in pharmacokinetics and understanding of principles of physiologically-based pharmacokinetic modeling.
Demonstrated strong proficiency in PK, PK/PD or popPK modeling (e.g., coding in NONMEM, R, MATLAB, Python, Phoenix)
Strong influencing and communication skills and demonstrated ability and creativity in solving tough problems.
A track record of scientific publications in the field.
Preferred Experience and Skills:
Hands-on experience with physiologically-based pharmacokinetic modeling software (e.g., Simcyp, GastroPlus) is highly desired.
Familiarity with advanced use of PK, PK/PD, PBPK/PD models is a plus
Experience with applying such models to specialized dosage forms (oral and non-oral extended release, inhaled, others)
External website https://jobs.merck.com/us/en/job/R60517/Senior-Scientist-Biopharmaceut
Contact email address: jchapman@haallc.com - 24th Jun 202 [3006]
Senior Director 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: gobeaun@mmv.org - 19th Jun 202 [3005]
PKPD Translational Medicine Scientist (post-doc fellowship)
JOB PURPOSE
Medicines for Malaria Venture (MMV) is a leading product development partnership (PDP) in the field of antimalarial drug research and development. Its mission is to reduce the burden of malaria in disease-endemic countries by discovering, developing and delivering new, effective and affordable antimalarial drugs.This 3-year post-doctoral fellowship will provide a PhD graduate with the opportunity to expand their scientific knowledge and skills, to see how pharmacometric approaches (PBPK and PK/PD) are used to speed up the drug development process, from early to late stage and to contribute to the development of innovative modeling approaches.
PRIMARY DUTIES AND RESPONSIBILITIES:
- Provide PBPK and/or PKPD modeling expertise to preclinical and clinical projects for antimalarial treatment or chemoprevention
- Depending on the expertise of the applicant, the job could focus on one of the following areas or include both:/li>
- PK/PD analyses of non-clinical and clinical studies, especially of combinations of new antimalarial compounds
- Development and application of PBPK modelling: PK DDI assessment between antimalarial drugs used in a combination and between antimalarial drugs and other treatment; improve PK predictions in African children; predict the effect of malaria on PK, predict PK in pregnant and lactating women
- Publish high quality research articles
- Attend selected conferences for training, giving presentations and posters, representing MMV
EDUCATION AND EXPERIENCE:
- Ph.D. in biomedical science, pharmacy, clinical pharmacology, biometrics or computational engineering
- 2 years of post-doctorate 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 is an asset
- Experience working in a cross-functional matrix setting is also an asset
- Technical skills required:
- Demonstrated competence in coding and running pharmacometric related software (e.g. NONMEM, Monolix, R, MATLAB, PBPK software)
- Competence in at least one of the following areas: PK, PKPD, disease progression, malaria, in vitro in vivo correlation
- Fluency in English (oral and written)
- Familiar with general software
LOCATION: Geneva, Switzerland
MORE INFORMATION AND APPLICATION: on https://www.mmv.org/about-us/work-us/jobs#op-395680-pkpd-translational-medicine-scientist-postdoc-fellowship MMV website
External website https://www.mmv.org/about-us/work-us/jobs#op-395680-pkpd-translational-medicine-scientist-postdoc-fe
Contact email address: cornelius.amberger@merckgroup.com - 3rd Jun 202 [3004]
Associate Scientific Director Discovery NCE DMPK (all genders)
Your role:
We are seeking an experienced Scientific Director to join our Discovery DMPK team Darmstadt.
As Scientific Director you will champion and develop new scientific ideas and concepts specifically focused on DMPK-related activities. This will include scientific excellence and validation of in vitro, in vivo and in silico DMPK assays. You will provide support for external opportunity evaluations. The role coaches peers and contribute to maintaining a strategic network within and outside. You will provide scientific input to DMPK strategic goals and contribute to the overall goal of Discovery DMPK of selecting high quality molecules to advance in our pipeline. The Scientific Director will collaborate with the Development DMPK teams to ensure that the right development studies are conducted to manage risk and de-risk identified liabilities. The role will have good understanding of PK/PD models preferentially with hands-on experience in using them to support discovery projects.
You will be DMPK representative in project teams and support projects from concept generation up to selection of development candidates (and beyond when needed). As project representative, you will identify DMPK related key issues in Discovery projects and provide inputs to the design of new molecules to address these issues. The Scientific director will compile DMPK data to predict human PK, and in collaboration with other relevant disciplines (Clinical Pharmacology, Discovery Pharmacology, Safety, Formulation, etc) predict human efficacious dose.
Who you are:
- PhD in Drug Metabolism, Pharmacokinetics, Chemistry or related fields with >10 years of experience in DMPK, Clinical Pharmacology or related fields
- Have a proven record of in-depth knowledge of DMPK science and its application in drug discovery
- Good scientific visibility through a substantial track record of relevant publications
- Team player with strong communication skills in a multicultural environment
- Strong negotiation skills with an ability to influence in complex situations
- Highly flexible and creative with a strong sense of responsibility
- Excellent knowledge of spoken and written English.
External website https://jobs.vibrantm.com/merck/job/Darmstadt-Scientific-Director-Discovery-NCE-DMPK-(all-genders)-H
Contact email address: telder@stem-sourcing.com - 21st May 202 [3003]
Director/Senior Director Pharmacometrics Quantitative Pharmacology
- Accountable for planning and executing state-of-the-art M&S techniques
- Scientific and strategic input into pre-clinical, clinical, and post-approval development plans
- Accountable for oversight, support and delivery of scientific and strategic modeling work related to specific projects
- Support evaluation of drug candidates for in/out-licensing
- Accountable for the identification and development of drug-disease models and other modelling approaches to support internal and external decision making in collaboration with internal and external partners (when relevant)
- Accountable to provide peer review and mentoring of junior staff
- Support and contribute to the development of the quantitative pharmacology in terms of providing training and knowledge sharing
- Monitoring external and internal environment in terms of relevant new methodologies and applications
- Ensure modeling efforts are aligned with current regulatory expectation
- Partner with the Preclinical Pharmacokinetic/Pharmacodynamics Team to enable translational PKPD efforts in the Discovery space
- PhD with 10-15+ years experience in industry
- Significant experience in modelling and simulation including PK, PKPD and statistics
- Demonstrated broad translational and clinical development expertise and experience exemplified by 15 years drug development experience (early and late), with emphasis on Pharmacometrics
- International recognition in the field on pharmacometrics
- Relevant regulatory experience (written/oral)
- Experience in managing and mentoring junior scientists, modelers and pharmacometricians
- Expert knowledge about modeling softwares, MATLAB, NONMEM, WinNonlin etc.
External website https://www.stem-sourcing.com
Contact email address: telder@stem-sourcing.com - 18th May 202 [3002]
Clinical Pharmacology Scientist
Be a subject matter expert in clinical pharmacology and work in tandem with quantitative pharmacology on strategy for the direction of the group and compounds in the pipeline. Contribute to regulatory documents e.g. IND's, NDA's and BLA's. This role requires a PhD with at least 2 years of industry experience. Ability to analyze PK/PD population software such as WinNonlin and NONMEM as well as others.External website https://www.stem-sourcing.com
Contact email address: broseberry@cartermackay.com - 8th May 202 [3001]
Bay Area CA AD/Director role available in Clinical Pharmacology-full time role with established client. please contact me at broseberry@cartermackay.com for more info. Job Details below: This individual will be responsible for the dual development and implementation of both Clinical Pharmacology and Modeling and Simulation (M&S) strategies in support of the company portfolio.
Professional Responsibilities:
- Integrate PK, PD, safety, and efficacy data with M&S methodologies, spanning population (PopPK) to quantitative systems pharmacology (QSP) approaches
- Will support multiple quantitative clinical pharmacology deliverables, both with hands-on contributions and of work conducted by external vendors
- Provide both departmental representation and subject matter expertise on development teams
- Author and/or review documents including clinical protocols, M&S analysis plans and reports as well as study reports, regulatory documents, and journal articles
- Attend and present at internal and external meetings as needed
- Support interactions with worldwide Health Authorities regarding clinical pharmacology issue
- Supervise outsourced studies with external vendors
- Ph.D. in Pharmacokinetics, Pharmacometrics, Engineering, Pharmaceutical Sciences, or related discipline
- 5+ years (10+ for director position) of industry, regulatory, and/or related post-doctoral quantitative clinical pharmacology experience Professional Requirements:
- Demonstrated experience with leveraging M&S approaches (e.g. PopPK, clinical trial simulation, and/ or QSP modeling) to inform drug development
- Excellent verbal and written communication skills and interpersonal skills
- Strong leadership and project management skills
- Hands-on experience with M&S software (e.g. NONMEM, R, MATLAB, and/or SimBiology)
- Regulatory filing experience is highly desirable
Contact email address: cvmopportunities@fda.hhs.gov - 1st May 202 [3000]
Vacancy Announcement
Staff Fellow positions: Clinical Pharmacologist– Division of Scientific Support
The Food and Drug Administration (FDA), Center for Veterinary Medicine (CVM), Office of New Animal Drug Evaluation (ONADE), Division of Scientific Support (DSS) is seeking qualified applicants for several Clinical Pharmacologist positions. DSS provides expertise, leadership, and coordination to all CVM offices regarding biostatistics, clinical pharmacology, and environmental safety evaluations for reviews and research. Through our independent and collaborative reviews and evaluations, we support the Center’s scientific and regulatory goals to approve safe and effective animal drugs. This position will be filled through FDA’s Staff Fellowship program. The appointment is up to 2 years with opportunity for renewal.
This position is located on the Clinical Pharmacology Team within the Division of Scientific Support in the Office of New Animal Drug Evaluation (ONADE). The function of the team is to evaluate the absolute and relative bioavailability of a new animal drug/drug product and the pharmacokinetics (absorption, metabolism, distribution, and elimination) of new chemical entities. You will analyze and interpret these scientific investigations, technical data, opinions, and related information, and make recommendations for Agency action regarding New Animal Drug Applications and Investigational New Drug submissions.
Applicants should have experience evaluating study designs, assay methodology, and sensitivity of the assay method of drug products and pharmacokinetics of chemical entities, performing pharmacokinetics & pharmacodynamics modeling and analysis utilizing software such as WinNonLin, NONMEM, or WinBUGS; and developing written summaries of bioavailability, bioequivalence, dissolution and pharmacokinetic studies.
Due to the immensity of its charge, CVM depends upon a diverse and dedicated workforce. We recognize the importance of multi-disciplinary teamwork in reaching superior and timely regulatory decisions therefore we foster an atmosphere where every employee’s contribution is important. New concepts, ideas, and creative approaches to improve current operations and to meet existing and future challenges are encouraged. Our goal is to not only enable our employees to positively impact the Center today, but to prepare our workforce for the demands, responsibilities, and career opportunities of tomorrow. ONADE offers many benefits and operates in a hoteling work environment. Hoteling is an arrangement where employees reserve non-dedicated, non-permanent workspace at the Rockville duty station on an as-needed basis and as required and telework when not at the Rockville duty station. ONADE provides the basic technology (e.g., laptop, monitors, webcam) needed to effectively work in the Rockville office and in a teleworking location. Hoteling, along with a strong telework program and strong electronic communication and workflow tools, affords employees in ONADE the flexibility to balance work/life demands while contributing to our high performing organization.
The position is located in Rockville, Maryland and is available immediately. The salary range for the GS-12 equivalent level is from $86,335 to $112,240, and for the GS-13 equivalent level from $102,663 to $133,465 based on experience and education. Further information regarding qualification requirements can be found at the following link: http://www.opm.gov/policy-data-oversight/classification-qualifications/general-schedule-qualification-standards/0400/pharmacology-series-0405/.
Please submit your letter of interest, resume, and transcripts to: CVMOpportunities@fda.hhs.gov with the subject line of “PharmPK” – Division of Scientific Support Staff Fellow Pharmacologist Position”. Questions may also be directed to the CVM Opportunities mailbox. **Applications will be reviewed and interviews will be scheduled on a first come, first serve basis.**
FDA is an equal opportunity employer and is a smoke-free environment.
External website https://www.fda.gov/about-fda/center-veterinary-medicine/working-cvm
Contact email address: broseberry@cartermackay.com - 15th Apr 202 [2999]
Sr. Director role in clinical pharmacology available in MA. This is a fantastic first in opportunity. please contact me for more info.
Description below.
- Lead the Clinical Pharmacology strategy to create sound, innovative and efficient programs that meet regulatory requirements, corporate and R&D program goals, and facilitate development from Phase 1 to commercialization
- Provide clinical pharmacology expertise in design and analysis of pharmacokinetic (PK) and pharmacodynamic (PD) aspects of clinical studies, including determining study design details, development of PK/PD models, special populations, dosing, evaluating clinical safety, efficacy, and patient selection strategies and predictive biomarkers
- preparation of the clinical pharmacology portions of regulatory documents such as the pre-IND, IND, IB, briefing documents, clinical study reports, CTA and filing documents, while working in collaboration with cross functional team
- Work with the discovery preclinical DMPK colleagues to optimize preclinical models and inform first in patient clinical dosing strategies
- Perform with adherence to agreed timelines and budgets to ensure execution of deliverables
- Represent Clinical Pharmacology and provide subject matter expertise on cross-functional project teams, clinical study teams and translational medicine teams
- Identify/manage consultants and vendors to support Clinical Pharmacology studies
- Excellent written and oral presentation skills
- Strong critical thinking and the ability to work effectively with cross-functional teams in a matrix environment
- Can work independently with minimal supervision
Job Requirements:
- MD, PharmD, or PhD with at least 10 years of Clinical Pharmacology experience (Level commensurate with experience-can be adjusted)
- Experience in a pharmaceutical or biotechnology industry role is preferred
- Strong understanding of Clinical Pharmacology principles, the drug development process and regulatory requirements to support Clinical Pharmacology strategies
- Proven excellence in applying technical knowledge to strategic planning
Contact email address: telder@stemsourcing.com - 9th Apr 202 [2998]
Clinical Pharmacology Lead
Lead all aspects of clinical pharmacology in the Translational Development group of this mid-sized pharma company. Mentor PhD and non-PhD level scientists as well as contribute individually. Use experience in PK/PD, quantitative modeling and simulation, drug development, TK, and nonclinical PK (DMPK and ADME). Provide expertise and guidance for clinical pharmacology plans with minimal supervision.
Qualifications:
PhD with at least 10 years of experience. Experience leading clin pharm programs and being awesome. Experience with PK/PD analysis on INDs, CTDs, NDAs etc. is required for this role. Experience using modeling and simulation software is also a requirement for this role as well as publications reflecting excellence in the field of clin pharm.
For more information on this role reporting to the Vice President of this group.
External website https://www.stem-sourcing.com
Contact email address: broseberry@cartermackay.com - 8th Apr 202 [2997]
New Director/Sr. Director role in Pharmacometrics available. Please email me with questions at broseberry@cartermackay.com
The Director/Sr. Director,will provide strategic and scientific expertise, as well as represent the dept. within the organization. This position will be accountable for developing and applying quantitative frameworks that enable model-informed drug discovery and development across the company portfolio. In addition, this position will ensure robust quantitative data and quality in all deliverables through direct scientific mentorship and management of other QP professionals.
Responsibilities
- Assist in the leadership of the department, and directly manage other QP professionals
- Lead and supervise all model-based activities and provide direct hands-on modeling expertise on select programs
- Develop and execute comprehensive quantitative pharmacology strategic plans as well as internal and regulatory decisions
- Work closely with Clinical Pharmacology colleagues to develop and deliver quantitative strategies to support assigned development plans
- Provide quantitative pharmacology and disease area subject matter expertise to Discovery and Development teams; influence the collection and use of nonclinical and biomarker data to inform human pharmacology, dose selection, and study design
- Oversee the development and execution of modeling analysis plans to support regulatory/submission deliverables
- Responsible for overseeing and guiding the scientific basis, predictiveness, and biological suitability of models and methods developed within team through mentoring scientists in conjunction with relevant disease pharmacology/biology as well as review of model code, diagnostics,
- Work closely with Clinical Pharmacology and Regulatory to provide appropriate quantitative pharmacology content to regulatory documents, communications and presentations as needed (IND, health authority inquires, preparation/participation in meetings with health authorities, preparation of BLA summary sections, addressing review inquiries, health authority sponsored Advisory Committee Meetings, etc.)
- Oversee preparation and review of PopPK, PKPD, ER, and other quantitative pharmacology reports and publications. Work with Clinical Pharmacology and Medical Writing to incorporate QP sections into clinical study reports
- Partner with the Preclinical Pharmacokinetic/Pharmacodynamics Team to enable translational PKPD efforts in the Discovery space
- PhD in Engineering, Pharmaceutical Sciences (PKPD emphasis) or other computational/quantitative discipline
- a minimum of 8 years of experience in the application of quantitative pharmacology
- Expertise in population analysis methodologies; knowledgeable in the use of computational tools including NONMEM, Monolix, R, Matlab, etc.
- Experience in mechanistic/semi-mechanistic pharmacological modeling as well as development of exposure-response, PKPD, disease, and/or QSP models is strongly preferred
Contact email address: broseberry@cartermackay.com - 3rd Apr 202 [2996]
Discovery/Preclinical PK/PD role in biologics available, east coast US. Job description: (level will be based on experience--ideally someone coming out of a post doc up through mid level)
- Participate inn Discovery-stage project teams as a subject matter expert for Preclinical Pharmacokinetics/ Pharmacodynamics, providing PK or PK/PD input to the design of preclinical PK/pharmacology studies.
- Work with various groups and PK/PD management in order to develop a PK strategy for each project.
- Effectively communicate project team queries, requests and expectations (i.e. timing and deliverables) from the Project Teams to subordinates and management.
- Execute and report PK and PK/PD analyses
- Work in close association with the Toxicology, Pathology, Clinical Pharmacology (CP) and Quantitative Pharmacology (modeling & simulation) functions, within the Drug Safety and Pharmacometrics (DSP) Department.
- Maintain an up-to-date knowledge of the relevant scientific literature as well as regulatory guidances and best practices as they pertain to PK/PD.
Requirements
- PhD in Pharmacology, Pharmacokinetics, Biology/Molecular Biology, Biochemistry,.
- Previous experience with protein/monoclonal antibody therapeutics is required.
- In-depth theoretical and applied understanding of PK and PD, in order to describe and understand the pharmacology/biology of therapeutic proteins, is required.
- Demonstrated ability to plan, organize, oversee PK and/or PK/PD studies, and analyze PK/PD data is essential.
- Excellent communication (written/verbal), presentation and leadership skills are required.
Demonstrated scientific creativity is required, together with the ability to propose innovative solutions. - Experience in drafting PK reports and IND's is desirable. please email me for more info
Contact email address: broseberry@cartermackay.com - 31st Mar 202 [2995]
Associate Director, Clinical pharmacokinetics available in southern CA with an established client. please contact broseberry@cartermackay.com for more info
The Clinical Pharmacologist is responsible for providing expertise including, pharmacokinetics (PK), pharmacodynamics (PD) to programs in all stages of development, ranging from pre-New Molecular Entity (NME) declaration through post-marketing support. Will be responsible and accountable for developing compound specific Clinical Pharmacology Development Plan and will apply and promote Clinical Pharmacology knowledge, including that of model-based drug development, in the programs they support for all stages of drug development. Will independently execute the day to day operations for the clinical pharmacology aspects of the assigned programs by managing directly or indirectly teams of employees of different levels.
Key Responsibilities:
Contribute to overall compound development via application of quantitative methods to integrate knowledge of PK, PD, patient characteristics, disease states, and drug—drug interactions to optimize dose selection, dosage regimens and study designs throughout drug development. Will be responsible for appropriate summarization and interpretation of results of PK/PD analyses with respect to their impact on development and clinical use of drugs. Independently or with assistance, clinical pharmacologists will translate quantitative knowledge into strategic opportunities with key stake holders to drive development along the model-based drug development principles.
- Accountable for all modeling and simulation activities in the program. Perform and/or liaise for modeling and simulation analysis of preclinical-clinical data, translational PK/PD data, up to first-in-human (FIH) and if applicable beyond FIH (dose/exposure-response analyses to guide dose regimen from pre-proof of concept (POC) studies and POC studies); Whenever appropriate perform and/or provide input and guidance to the prediction of clinical response and study outcomes of Phase 2b, and Phase 3 trials and to optimize trial designs. Consider alternate and appropriate dosing recommendations for special situations (e.g., drug interaction, food effect, pharmacogenomics effect, pediatric, elderly, renal impairment, hepatic impairment).
- Partner with functional representatives in biology, chemistry, biomarker, translational medicine, CDTLs and clinicians to develop CPDP and design suitable early PKPD plans on projects
- Engage discovery project teams early to aid in PKPD, biomarker, and efficacious dose prediction strategies
- Design and execute PKPD modeling efforts to address the unique challenges pertinent to the project
- Contribute to preparation of monographs, INDs and other documents as applicable to support clinical studies
- Seamlessly transfer project knowledge/assets to the relevant team upon FIH (or an alternative mutually agreed upon point)
- Where applicable, find common areas of need across projects (and possibly across TAs) that could benefit from a common modeling approach/platform
- Mentor other CP colleagues in the science of preclinical PKPD modeling, simulation and efficacious dose prediction
- Remain current with clinical and drug development information and methods in modeling and simulation by engaging with the scientific community (e.g., publishing, presenting at meetings, participating in special interest groups within professional societies, etc.) and internalize key learnings back to Janssen
- Develop key product differentiation strategies based on a compound’s key attributes and relevant therapeutic landscape in CPDP; subsequently continue to liaise with key functional partners to provide product differentiation strategies throughout the drug development continuum.
- Define regulatory strategy for CP and prepare CP contributions to regulatory documents including IBs, IND’s, briefing books, NDA / MAA submissions, bridging documents, post-approval filings, and responses to health authority questions and where appropriate represent CP in relevant external regulatory meetings (eg, End of Phase 2, pre-NDA / MAA, Advisory Committee meetings).
- When requested, participate in the evaluation of potential business development opportunities.
- Present and/or publish scientific data at conferences and in peer-reviewed journals, stay abreast of new emerging technologies in relevant scientific fields; identify new opportunities for applied scientific and technical advancement within the division.
- Work effectively in matrix environment, managing CP deliverables in accordance with timelines and overall project goals.
- Apply appropriate regulatory (eg: FDA, EMEA, ICH etc) guidelines in the design of clinical development plans and studies.
PhD, MD, PharmD or equivalent degree in Pharmaceutical Sciences, Clinical Pharmacology, Biomedical Engineering, or relevant Biological Sciences with a minimum of four (4) years of pharmaceutical development experience with at least 3 years of relevant experience performing progressively advanced duties at the Senior Scientist level and 5+ years experience for the Associate Director level.
Experience and Skills:
Demonstrated understanding of overall process of drug development and the overall pharmaceutical R&D process is required.
Has established a strong level of expertise and scientific reputation through multiple publications and presentations, preferred.
External website https://na
Contact email address: jchapman@haallc.com - 26th Mar 202 [2994]
Check out this new opportunity from one of our top clients. Below is a brief description of the role.
Job Description
The Scientist/Director will lead the clinical pharmacology activities on a multi-disciplinary team.
Responsibilities
- Design and implement clinical pharmacology studies and strategies for the team.
- Analyze PK/PD data and interpret the results.
- Support translational efforts in support of clinical development plans.
- Contribute to regulatory activities and help maintain overall compliance in the group.
Job Requirements
- Ph.D. in Clinical Pharmacology, Pharmacometrics, Pharmaceutical Sciences, or related field.
- 5+ years of industry experience.
- Clinical pharmacology expertise in translational medicine and drug development.
- Experience analyzing PK/PD data using modeling and simulation expertise.
If you are interested in learning more, please reach out to me at jchapman@haallc.com.
Contact email address: jchapman@haallc.com - 26th Mar 202 [2993]
Check out this new opportunity from one of our top clients. Below is a brief description of the role.
Job Description
The Sr. Director will lead the clinical pharmacology activities on a multi-disciplinary team.
Responsibilities
- Design and implement clinical pharmacology studies.
- Perform model-based analysis of PK/PD and exposure-response data to support dosage selection.
- Develop models to evaluate disease progression and trial design performance.
- Contribute to the clinical pharmacology sections of trial protocols and reports, brochures, and regulatory submissions.
Job Requirements
- Ph.D. in Clinical Pharmacology, Pharmaceutical Sciences, or related field.
- 10-15+ years of industry experience.
- Clinical pharmacology expertise in the oncology therapeutic area.
- Experience analyzing PK/PD data using modeling and simulation expertise.
- Expertise with modeling tools such as NONMEM, WinNonlin, SAS, and MATLAB.
If you are interested in pursuing further, please reach out to me at jchapman@haallc.com!
Contact email address: jchapman@haallc.com - 26th Mar 202 [2992]
Check out this new opportunity from one of our top clients. Below is a brief description of the role.
Job Description The Director will lead the clinical pharmacology activities on a multi-disciplinary team.
Responsibilities
Design and implement clinical pharmacology studies.
Perform model-based analysis of PK/PD and exposure-response data to support dosage selection.
Develop models to evaluate disease progression and trial design performance.
Contribute to the clinical pharmacology sections of trial protocols and reports, brochures, and regulatory submissions.
Job Requirements
Ph.D. in Clinical Pharmacology, Pharmaceutical Sciences, or related field.
8-10+ years of industry experience.
Clinical pharmacology expertise in the oncology therapeutic area.
Experience analyzing PK/PD data using modeling and simulation expertise.
Expertise with modeling tools such as NONMEM, WinNonlin, SAS, and MATLAB.
If you are interested in pursuing further, please reach out!
Contact email address: david.anderson1@takeda.com - 25th Mar 202 [2991]
The DMPK department at Takeda, Cambridge, MA is seeking a highly motivated Scientist to join the Drug Transporter group. The primary responsibilities will include the assessment of NCEs as a potential substrate and inhibitor of drug transporters using various cell-based assays to support projects in early discovery and development stages. A strong understanding of the role of drug transporters in drugs’ ADME and enzyme-transport interplay is critical to this role.
The position level will depend on the level of experience in the relevant areas.
Duties and Responsibilities
- Handle and maintain mammalian cell culture,
- Conduct cell permeability experiments and in vitro drug transporter studies using various platforms including stably transporter-overexpressed mammalian cells, primary hepatocytes, and membrane vesicles, etc.,
- Conduct drug transporter substrate and inhibition assays using radiolabeled and non-radiolabeled probe substrates,
- Hands-on experience in operation, maintenance and troubleshooting of HPLC and LC-MS/MS, and
- Independently design and execute experiments, analyze, critically interpret and document data in reports
- Applicants should possess a PhD, MS, or BS in Biological Sciences/Pharmaceutical Sciences or in other relevant field with 0-2 years (PhD), 6+ years (MS) or 8+ years (BS) of pharmaceutical industry experience.
- Hand-on experience in cell culture of mammalian cells and primary hepatocytes. Prior experience in running permeability and drug transporter substrate/inhibition assays
- Strong background in using and troubleshooting HPLC and LC-MS/MS for small molecules, peptides, and proteins
- Good understanding of the role of drug transporters in ADME, transporter-mediated drug-drug interactions (t-DDIs) and enzyme-transporter interplay
- Experience in utilizing radiolabeled material in drug transporter studies.
- Previous experience in handling new therapeutics modalities including peptides, proteins and anti-sense oligonucleotides (ASOs) will be preferred.
- The candidate must be able to design and interpret data independently and maintain detailed, accurate and comprehensible study documentation.
External website https://takeda.wd3.myworkdayjobs.com/External/job/Boston-MA/Associate-Scientist---Scientist-I---Drug
Contact email address: amir.youssef@synteract.com - 20th Mar 202 [2990]
An Associate Director, Pharmacokinetics position is open at Synteract. The position can be office-based or remote-based in the US.
Who We Are
Synteract is a global full-service contract research organization with a successful three-decade track record supporting biotechnology, medical device and pharmaceutical companies. With our mission of ”Bringing Clinical Trials to Life,” we provide customized Phase I through IV services internationally, offering expertise across multiple therapeutic areas including notable depth in Oncology, Neuro Degenerative Diseases, and Rare and Orphan Diseases, and in pediatric populations. Our mission is to support the innovation and development of better therapies in healthcare.
Position Overview
The Associate Director, Pharmacokinetics will be responsible for conducting PK/PD modeling and population PK analyses using WinNonlin, NONMEM and/or PKSim with a focus on designing optimal dosing regimens for adult, pediatric and other special patient populations. Provide pharmacology, pharmacokinetic consulting to clients with a specialization on pediatric patient populations. Design, analyze and report pre-clinical and clinical pharmacokinetic, PK/PD modeling and trial simulation studies.
Specific tasks would include:
- Conduct PK/PD analyses, modeling and simulation in WinNonlin, NONMEM and/or PK-Sim for adult, pediatric and other special patient populations requiring dose regimen modification.
- Assist clients in the design and development of pre-clinical and clinical protocols with respect to toxicokinetic and pharmacokinetic analyses
- When the lead PK Scientist on assigned projects, act as the project manager to include functioning as the principal liaison with key clients, vendors, and internal team members.
- When the lead PK Scientist, will create trust and confidence amongst clients, vendors and team members while delivering on-time, and on-budget programs that leverage the various resources, expertise and cross function knowledge available within Synteract.
- Work with client’s data management group to prepare data sets for import and analysis in WinNonlin and/or NONMEM.
- Conduct non-compartmental (NCA) and compartmental PK analysis is Phoenix WinNonlin -PKSo.
- Responsible for locking and unlocking studies/scenarios in the PKSo database following management authorization.
- Writing stand-alone PK reports and PK study report sections for CSR’s
- Responsible for ensuring study data and study reports are retained according to the corporate records retention policy.
- Ensuring corporate quality policies and SOPs are followed during the analysis and reporting of PK studies
- Provide pharmacology, pharmacokinetic and drug development consulting services to clients with a specialization in pediatric drug development.
- Ph.D./ Master's Degree in Pharmacokinetics or Pharmaceutical Sciences, plus knowledge of how to support pediatric Pharmacokinetic/Pharmacodynamic modeling and simulations, specifically population PK and/or PBPK with 2-5 years of experience (including Industrial or academic post-doctoral training).
- Candidate must have knowledge of nonlinear mixed effect modeling and hands-on modeling experience using NONMEM
- Intermediate knowledge of GCPs, ICH guidelines, FDA and other applicable country regulations.
- Intermediate proficiency in Microsoft Word, MS Project, Excel, and PowerPoint, Outlook.
- Effective verbal and writing skills, English + local language, if relevant.
Synteract’s policy is to provide equal employment opportunity and affirmative action in all of its employment practices without regard to race, color, religion, sex, national origin, ancestry, marital status, protected veteran status, age, individuals with disabilities, sexual orientation or gender identity or expression or any other legally protected category. Applicants for positions with Synteract must be legally authorized to work in the country which they are applying, and verification of employment eligibility will be required as a condition of hire.
Please apply at https://www.synteract.com/Careers/Career-Opportunities
External website https://www.synteract.com/Careers/Career-Opportunities
Contact email address: telder@stem-sourcing.com - 17th Mar 202 [2987]
The Clinical Pharmacology Leader is a highly scientific role, supporting study design, PK and PK/PD analyses, and overall drug development support. The candidate will have an excellent knowledge of Clinical Pharmacology principles, such as PK, PK/PD, drug metabolism, and DDI, as well as a good understanding of related disciplines such as pharmaceutical development, regulatory, and overall drug development.
Key Responsibilities:
- Performs analysis of clinical pharmacology data (PK/PD) from phase 1-4 clinical studies with minimal supervision.
- Develops clinical pharmacology data analysis plans with minimal supervision.
- Provides peer-reviewed interpretation of clinical pharmacology data and incorporates appropriate analyses into reports required for regulatory submissions.
- Provides complex clinical pharmacology input to clinical development plans, Investigator's Brochure and Clinical Pharmacology section of INDs, CTAs and/or NDAs with supervision.
- Leads study conceptualization, protocol development, and study start-up activities, including site initiation and investigator meetings.
- Prepares responses to inquiries from regulatory agencies with minimal supervision
- Provides scientific and technical input about clinical pharmacology-related issues within project teams, as assigned.
- Collaborates with colleagues in bioanalytics, biometrics, clinical development, drug metabolism and pharmacokinetics, toxicology, and regulatory affairs for clinical studies.
- May have the ability to manage and mentor junior scientists and help grow the clinical pharmacology team.
- Ph.D. in Pharmacokinetics, Pharmaceutical Sciences, or other life sciences with experience in the Biotechnology/ Pharmaceutical Industry or post-doctoral training.
External website https://www.stem-sourcing.com