The Department of Pharmacy Practice at UIC is seeking a postdoctoral research associate to work on a collaborative clinical project involving pharmacokinetic analysis in pregnant women. A PhD degree in pharmacokinetics, analytical chemistry, or other relevant areas is required. The candidate will analyze biological samples for quantitation of small molecules using LC-MS/MS and may have an opportunity to learn and perform population PK analysis using NONMEM. Experience in rodent handling is desired if the candidate wants to be involved in other ongoing projects in the laboratory. For information about other projects in the lab, please visit http://openwetware.org/wiki/Jeong_lab. For fullest consideration, applicants should send a CV and three references by August 31, 2017 to: Young Jeong at firstname.lastname@example.org.
External website http://openwetware.org/wiki/Jeong_lab
Contact email address: email@example.com - 21st Jul 2017 
Head of Clinical Pharmacology Location: West Coast and East Coast
Job Description Serve as the Head of Clinical Pharmacology providing expert Strategy, Management, and Regulatory Guidance throughout the Drug Development process.
Key Responsibilities Create and implement study designs, and oversee study progression. Lead the analysis of PK, population PK, and PK/PD data. Support dosage selection and go/no-go decisions. Oversee regulatory activities internally and externally.
Experience Level Ph.D. in Clinical Pharmacology, Pharmacokinetics, Pharmaceutical Sciences, or related field. 12-15+ years of industry experience. Experience designing and analyzing clinical pharmacology studies using modeling and simulation. Working knowledge of clinical pharmacology tools including work with modeling software such as NONMEM, WinNonlin, and Phoenix.
Director of Pharmacometrics Location: Northeast
Job Description Create and implement key pharmacometrics strategies for drug discovery and development.
Key Responsibilities Lead all pharmacometrics activities in multi-disciplinary teams. Manage team activities such as maintaining budgets, objectives, and timelines. Collaborate with other project teams, as well as external experts to develop models. Use model-based analyses to inform dosage selection.
Experience Level Ph.D. in Pharmacometrics, Pharmacokinetics, Pharmaceutical Sciences, or related field. 12-15+ years of industry experience. Experience using quantitative analysis, modeling and simulation, and statistical data analysis. Working knowledge of pharmacometrics tools such as WinNonlin, SAS, MATLAB, among others.
If you are interested please reach out to Jay Chapman at firstname.lastname@example.org or (704) 333-5213.
Contact email address: Gli9@its.jnj.com - 14th Jul 2017 
The is an excellent opportunity for the following positions with international level of remuneration. Led by half-a-dozen of UK/EU/USA-trained graduates, the Johnson and Johnson Clinical Pharmacology Department in China is expanding, in view of rapid market growth in China, and participation in increasing pipelines of Johnson and Johnson. Therapeutic and disease strong-holds include oncology, immunology, cardiovascular & metabolic, neuroscience, and infectious diseases & vaccines.
At Johnson & Johnson we are recruiting for Clinical Pharmacologist with M&S expertise for our China R&D center, based both in Shanghai/ Beijing. Our vision is to have a fully integrated end-to-end R&D organization in Asia that innovates and develops products in Asia that delivers significant benefits to patients in the region and globally.
Minimum Qualifications for Clinical Pharmacologist
The position is responsible for delivering quantitative pharmacology and modeling/simulation supports to discovery and development of both small molecules & biologics, from pre-New Molecular Entity (NME) declaration through post-marketing development in China R&D organization. The responsibilities also include active participation in Clinical Teams/Compound Development Teams. Individual position is based, in part, on the educational background, degree of experience, displaying a progression in the level of expertise and level of independence shown.
Sr. Associate Scientist: M.S. degree with >3 yrs industry experience; Scientist: Ph.D. degree with 0 to 3 yrs industry experience; Manager: Ph.D. degree with 0 to 7 yrs at the previous level
Minimum Qualifications for Clinical Pharmacology Leader
- PhD, MD, or equivalent degrees, with 5 years or more of pharmaceutical development experience
- Ability to lead and/oversee multiple smaller Clapham programs independently
- Comprehensive clinical pharmacology experience and M&S experience is required.
- Broad drug development experience in one or multiple Therapeutic Areas with a focus on oncology, respiratory, immunology and hepatitis compounds
- Significant drug development experience for both small and large molecules is required.
- In-depth knowledge of statistics & broad knowledge in statistical modeling concepts and application, including linear and nonlinear regression modeling, semi-parametric and parametric modeling, logistic regression, generalized linear models and mixed-effects models etc.
- Thorough knowledge of PK/PD modeling principles is required
- Experience in the use of scientifc software for modelling, simulation or programming (such as SAS, NONMEM, R or S-plus)
- Working knowledge in model building, diagnostic and validation methods
- Experience with clinical trial simulation to derive operating characteristics of study and program designs is highly desirable.
- Fluent in written and oral communication skills
- Ability to build and maintain effective working relationships in a cross-functional team environment
- Ability to multi-task and prioritize assignments
- Actively identifying new areas for learning, and application to the job
- Excellent sense of cultural sensitivity and diversity
- Self-motivated with the ability to work independently with minimal supervision
Contact email address: email@example.com - 12th Jul 2017 
PhD research fellowship: Pharmacometrics and Computational Disease Modelling
The Graduate Research Training Program PharMetrX: Pharmacometrics & Computational Disease Modelling is an interdisciplinary PhD program bridging pharmacy and mathematics.
The PharMetrX program comprises an excellent research environment in the vibrant Berlin/Potsdam area, fascinating and innovative research projects in a highly relevant field, truely transdisciplinary supervision, an individual mentorship from one of the industry partners and a highly competitive 3.5 year fellowship.
In addition, PharMetrX offers a specifically tailored training curriculum and a network of peers, both of which are also open for external PhD students from other universities.
We are currently inviting applications to start the PharMetrX PhD program in March 2018. PharMetrX is open to candidates with a university degree in pharmacy, mathematics/statistics, natural sciences or medicine.
Deadline for applications: September 15th, 2017. For details see https://www.PharMetrX.de.
PharMetrX is a joint program of the Freie Universität Berlin and the Universität Potsdam, supported by several global research-driven pharmaceutical companies.
Charlotte Kloft & Wilhelm Huisinga Program Chairs
External website http://https://www.PharMetrX.de
Contact email address: firstname.lastname@example.org - 3rd Jul 2017 
Posted: 13/06/2017 14:28
Salary: Competitive Location: Cambridge, UK Level: Scientific
Deadline: 13/08/2017 23:59 Hours: 37.50 Benefits: Excellent range of benefits Job Type: Permanent
We have a new opportunity for a Principal Translational Scientist to assist in the development and implementation of the translational strategy to our novel pipeline of early phase bispecific mAb2 molecules for immune-oncology. What does success in this role look like? Effectively guiding internal and external teams to produce quantitative translational datasets to enable the selection of best-in-class molecules and a well-defined data package to enable successful clinical development.
- Responsible for providing technical and scientific contribution to the biomarker strategy for multiple IO bispecific mAb projects
- Work as part of a multidisciplinary team to develop the translational and clinical biomarker strategy
- Liaise closely with preclinical pharmacology and discovery groups to characterize the fundamental biology of targets and translation across species to ensure appropriate endpoints are measured for target engagement and pharmacodynamic effects.
- Perform the appropriate scholarship required to develop hypothesis driven approaches to the targeted use of quantitative biomarkers
- Oversee the technical and operational aspects of mechanistic biochemical biomarker analysis (e.g. sample collection through to data generation and interpretation)
- Continually assess the latest technologies available and provide input to the internal and external capabilities required to support the portfolio needs.
- To represent F-star at external meetings including contributions at meetings by way of presentations, scientific committee representation and publications.
- Drive a culture of inclusivity and active engagement with translational goals and thereby translational understanding across the company.
- PhD in Life Sciences or equivalent experience
- Experienced biomarker scientist with demonstrated ability supporting translational and clinical mechanistic biochemical biomarker activities to assess target exposure, engagement/ occupancy and pharmacodynamic effects in collaboration with internal and external partners e.g CROs, consultants, and collaborating organisations
- Experience utilizing data e.g via statistical analysis and data visualisation, from a broad arrange of technology platforms to assess biomarkers including but not limited to immunoassays, flow cytometry, omics platforms etc
- Proven ability to drive the implementation of a biomarker strategy in preclinical or clinical studies
- Provide technical, scientific and regulatory input for the measurement biochemical biomarkers
- Experience working with technical staff to ensure assays are developed to ensure they are fit for purpose to support drug development programs
- Experience working within a matrix environment with a wide range of drug discovery and development stakeholders to include Preclinical Pharmacology, Protein Sciences, Clinical development etc •Demonstrated ability to work with and influence teams to ensure bioanalytical data generated is fit-for-purpose and of the required quality
- Experienced in bioinformatic data mining of human cancer biology data repositories to extract and compile therapeutic target profiles to support cancer indication selection.
- Familiarity with PK/PD or systems pharmacology modelling approaches.
- Biopharmaceutical drug discovery/development
- Project management skills
- Data visualisation and analysis
External website http://www.f-star.com/careers/
Contact email address: email@example.com - 30th Jun 2017 
Sr. Director/Director, Clinical pharmacokinetics and modeling/simulation position available--NJ/PA, US.
The successful applicant will be responsible for:
- Supervise PK data analysis and interpretation with appropriate tools and be able to incorporate into clinical development
- Strategize PK and PK/PD investigations in Phase I, II, III and IV studies
- Strategize meta-analysis of population PK and PK/PD data
- Manage CROs and also junior staff/direct reports
- Evaluate the relationship between exposure and (PD) properties for compounds from discovery to proof of activity, and to late stage Phase 3 development
- Set PK and PK/PD strategies and overall clinical pharmacology characterization strategies for compounds under drug development for global regulatory submission
- Supervise and/or prepare the eCTD dossiers of sections 2.5, 2.7.1 and 2.7.2 for NDA submission
- Provides expert scientific and strategic consultation to R&D, Regulatory Affairs, Regulatory Agencies, and all levels of management on critical decisions and development plans for multiple projects across multiple therapeutic areas
External website http://firstname.lastname@example.org
Contact email address: email@example.com - 21st Jun 2017 
POSTDOCTORAL ASSOCIATE, Biological Engineering-Tissue Chips in Space Project, to join the team of Dr. Murat Cirit and Professor Alan Grodzinsky. The Tissue Chips in Space program will focus on human physiology and disease onboard the International Space Station (ISS) U.S. National Laboratory. Data from this translational research--which will feature “tissue chips” (or “organs-on-chips”)--will help scientists develop and advance novel technologies that benefit human health on Earth and in space. The MIT research focuses on a cartilage-bone-synovium joint tissue chip model to study the effects of space flight on musculoskeletal disease biology. Duties include working with postdocs and technical staff to support original research in post-traumatic osteoarthritis (PTOA), which may include computational analysis of metabolomics and proteomics data, developing algorithms for patient stratification for selected drugs, biostatistical analysis of therapeutic drug intervention in in vitro systems, translation of in vitro results to in vivo clinical outcomes, and developing algorithms to understand effects of micro-gravity on drug efficacy.
REQUIRED: Ph.D. in engineering, statistics, or relevant field; post-graduate experience in the biological field; experience with computational modeling of biological networks with large data set (-omics) and knowledge of currently used computational approaches; expertise in biological network construction, multi-scale modeling, and the integration of multiple datatypes including metabolomics and proteomics; experience with a variety of computational biology techniques, software packages (R, MATLAB, Python), -omics databases, and algorithms to analyze –omics data; ability to work independently and collaboratively in fast-paced environment with competing priorities; and strong publication record. Experience with mechanistic models (PKPD, PBPK, and ODE- and PDE-based) and experience developing analytical workflows for metabolomics or proteomics data sets a plus. Job #14881
19th Jun 2017 
Senior Investigator - PK-PD/QSP Modeling, Translational Medicine (Cambridge, MA)
Job Description The Investigator III/Senior Investigator I is expected to develop/apply translational PK-PD modeling, PBPK-PD modeling, quantitative & systems pharmacology (QSP) modeling, along with data analysis techniques to facilitate drug discovery, development, and translational research across disease areas.
Key responsibilities: (1.) Serves as an expert modeler to provide translational modeling support for global drug development projects; (2.) Acts as a modeling liaison to bridge between the modeling line function and research/development teams from different disease or therapeutic areas; (3.) Performs and oversees biomarker PK / PD analyses using a variety of tools and approaches; (4.) Scripts/writes custom models; (5.) Integrates, interprets and reports data to project teams and other customers; (6.) Drives data-driven modeling at the drug discovery stage across disease areas; (7.) Develops and implements state-of-the-art modeling techniques (such as QSP or virtual human/animal/organ models) to impact drug development projects from discovery to early development; (8.) Demonstrates scientific creativity, collaboration works independently with project teams; (9.) Reviews and advises on translational modeling strategy for discovery programs; (10.) Executes modeling plans, and deliver reports of results
EEO Statement The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
- PhD in pharmacometrics/pharmacology/physiology, biomedical/chemical engineering, or related sciences with hands on experience with modeling tools such as MATLAB, Phoenix, Simcyp, etc. with a minimum of 3-10 years relevant industry experience
- Extensive modeling experience for biological/physiological/phathological/pharmacological systems
- Core competency in mathematics and numerical analysis including ordinary/partial differential equations, numerical optimization, stochastic modeling, etc.
- Exceptional problem-solving skills, learning agility, and collaborative behaviors
- Extensive experience with systems biology/physiology/pharmacology modeling or Virtual Human/Animal/Organ models, PBPK/PD modeling, translational PK-PD modeling, or data analyses
- Broad knowledge of drug discovery and development, e.g., on topics of drug delivery, formulation, ADME, PK/PD or TK/TD, etc.
- Excellent written and oral communication skills
Contact email address: Moss.Kai@gene.com - 30th May 2017 
The Clinical Pharmacology Department with Development Sciences at Genentech, Inc. is seeking a motivated Manager or Senior Manager who will manage the Modeling and Simulation Analyst (MSA) group at South San Francisco site. The MSA group sits in the Modeling and Simulation (M&S) Group within the Clinical Pharmacology Department. This group of programmer analysts is experienced in clinical data handling, implementing a variety of analytic software like SAS, R, S-Plus, NONMEM, and Spotfire to integrate PK drug concentration-time measures, pharmacodynamic responses, and clinical safety and efficacy information.
Responsibilities of the MSA job function includes:
Understanding, planning, and preparation of Modeling and Simulation data needs. Lead the programming efforts for generation of PKS and NONMEM datasets, statistical summary tables, listings and graphical reports.
Detection and tracking of data issues.
Generation and maintenance of regulatory documentation (i.e., metadata required for CDISC ADaM as well as non-CDISC data submission, assistance with data reviewer guides).
Exploratory analysis (e.g., visualizations, statistical summaries, simply M&S)
Lead or assist on analysis/visualization applications development projects (e.g. R-Shiny applications or markdown)
Lead or assist on efforts involving the development of standardization and process optimization.
This individual will manage MSA employees and contractors, and be accountable for MSA activities including effective resourcing, efficient operations, timely delivery, quality assurance, and regulatory compliance. He/she should be an effective people manager and committed to the continuous career growth for all MSAs in the group.
This individual will also be responsible for the set-up and maintenance of systems for programming, data access, sharing, and storage in Clinical Pharmacology. He/she should also take initiative and lead the development of standardization and process optimization. All of the above will be accomplished by working in close partnership with other employees in Clinical Pharmacology, SPA, CDM, quality control teams, and project teams.
M.S. or B.S. or equivalent experience in Statistics, Mathematics, Pharmacometrics, Engineering, Computer Science, or related discipline with 9+ years of programming experience in drug development with extensive record of on-the-job success.
Candidate should have solid hands-on expertise in SAS and R programming for various types of clinical trial data. Rich knowledge of the drug development process, clinical data systems, and global regulatory standards on datasets (CDISC) is required. Working experience with M&S dataset, methodologies, and software (such as NONMEM) is highly desired. Experience in interaction with global regulatory agencies is preferred. Knowledge and experience with software or application platform development is also a plus.
The candidate must have proven track record of strong communication skills, interpersonal skills, people management skills, and leadership skills including motivation, delegation, and conflict management in a fast-paced multi-tasked matrix environment. The candidate should be highly motivated to take initiatives to set-up and continuously optimize work processes. The candidate should have ability to establish and maintain effective working relationship with cross-functional team members. Good project planning and organizational skills are highly desired.
29th May 2017 
Your role: The Head of PK/PD Data Processing will lead a team of PK/PD analysts who perform or oversee clinical PK and PK/PD data preparation, evaluation, visualization, and interpretation, and provide input to concept sheets, protocols, reports or presentations, informing and supporting (trial) teams and projects across all therapeutic areas. You will define, establish and maintain efficient, high quality processes and ensure that all PK/PD, submission-relevant analyses are provided on time and according to Merck and regulatory quality expectations. You will drive team members development, coaching, and ensure critical expertise, processes, and systems are maintained and sustained.
Who you are:
- Ph.D. in pharmacokinetics/Pharmaceutics/Pharmacy or a related discipline and at least 5 years of relevant industry or government experience
- Expert knowledge in clinical research and development areas with demonstrated expertise and strong quantitative skills in PK/PD data management and analysis using statistical and pharmacokinetic evaluation programs
- Expert Knowledge of data standards (CDISC's SDTM and ADaM), IT/ program validation / ICH/GxP.
- Coaching, mentoring, and people management skills
- Fluent spoken and written English. Additional local language is an asset
26th May 2017 
Genentech is hiring.
Associate Scientist/Scientist/Sr Scientist, Preclinical and Translational PKPD (PTPK) (Job ID 3403146330)
The Preclinical and Translational PKPD (PTPK) Department within Development Sciences at Genentech, Inc. is seeking a PhD level scientist who is driven to understand the pharmacokinetics (PK) and pharmacodynamics (PD) of novel drug candidates. The candidate will be responsible for investigating the pharmacokinetics, biodistribution, and PKPD relationships of novel therapeutics in preclinical models to identify lead candidates for further development, and for translating preclinical PKPD information to patients. The candidate will be working in close partnerships across various functions including Research, Development Sciences, Clinical Sciences, Biostatistics, and Regulatory. The candidate will represent the department on cross- functional project teams as a PKPD representative and present PKPD results at cross- functional teams, department meetings, review committees, and conferences.
Who You Are:
We are looking for individuals who are inspired by our mission and who would fit in well with the collaborative, rigorous and entrepreneurial spirit of the company culture.
- A Ph.D. in Pharmacokinetics, Pharmaceutical Sciences, Pharmacology, Biomedical Engineering or related discipline.
- Minimum of 0+ years (for Associate scientist), 3+ years (for Scientist), and 7+ years (for Senior Scientist) of relevant PKPD experience (post-doctoral experience included) and demonstrated impact on drug development and/or the PKPD scientific landscape. Preferred qualifications:
- Strong knowledge and experience in either oncology, immunology, tumor immunology, infectious disease, and/or ophthalmology are highly desired.
- Strong knowledge and experience in PK and PK/PD of large molecule therapeutics (e.g., monoclonal antibodies, bispecifics, fusion proteins, antibody-drug conjugates, etc.) are highly desired. Working knowledge of PK/PD software (e.g., WinNonlin, NONMEM, ADAPT II) and the ability to critically assess PK/PD data is necessary
- The candidate should have experience working on cross-functional teams, demonstrate excellent communication skills, and have the ability to work independently and effectively.
External website http://bit.ly/2qkwTxw
Contact email address: firstname.lastname@example.org - 11th May 2017 
The School of Pharmacy at the University of Kentucky is offering a postdoctoral fellowship position in clinical pharmacology and pharmacometrics.
This position is focused on the application of pharmacokinetic/pharmacodynamic and disease modeling/simulation to facilitate the drug development in industry and improve patient care in academic setting.
The candidate will have the opportunity to gain a breadth of experience including: population pharmacokinetic/pharmacodynamic and complex mechanistic modeling of the biotechnology and small molecule drugs; disease progression and risk prediction modeling for patients with various diseases using data from clinical settings and private/government health insurance database; and others.
The candidate also has an option to involve in the development and evaluation of the advanced numerical and computation methods for population data analysis.
An ideal candidate will have a doctoral degree (PhD, PharmD) in pharmaceutical science, engineering, biology, pharmacy or other related field and have experience or familiarity with mathematical modeling, such as NONMEM, MATLAB, R, or any other applicable software. Knowledge with C++ and phyton programming is a plus.
For more details and information and how to apply please follow the link:
Additional inquiries may be sent to chee.ng_at_uky.edu
Chee Meng Ng, PharmD, PhD, FCP Associate Professor of Pharmaceutical Science College of Pharmacy University of Kentucky Email: chee.ng_at_uky.edu
External website http://https://ukjobs.uky.edu/postings/143145
Contact email address: email@example.com - 3rd May 2017 
Associate Director Position Profile – Clinical Pharmacology Oncology
Support oncology drug development by providing clinical pharmacology / DMPK expertise across early and full development phases, and global medical affairs. Represent Oncology Clinical Pharmacology (OCP) global line function on cross-functional teams and influence design, execution, and analysis of clinical pharmacology / DMPK related study components.
1) Contributes expert pharmacokinetic / DMPK input into key pre-clinical and clinical, and regulatory documents including clinical study protocols, clinical study reports, investigator brochures, IND / IMPD’s and NDA’s within agreed timelines, and meeting all regulatory requirements under minimal guidance from manager. 2) Designs clinical pharmacology strategy for assigned program and coordinates pharmacokinetic / DMPK related elements for preclinical and/or clinical projects. Identifies potential project hurdles, suggests solutions and establishes contingency plans. Represents OCP on Global Program Team(s) or early project teams. 3) Performs or oversees PK and PK / PD analyses using a variety of tools and approaches. Integrates, interprets and reports data to project teams and other customers. 4) Ensures constructive collaboration within drug development teams (GPTs, etc) and with other internal partners (e.g. DMPK, Toxicology, Modeling and Simulation, Formulations, Drug Regulatory Affairs, Clinical Development). 5) Defines and updates as appropriate the PK, PK/PD, DMPK biopharmaceutical and M and S requirements in the OCP and/or preclinical project development plans. 6) Monitors study timelines, objectives and budgets, ensures accuracy of project progress in company tracking tools (e.g. Succeed). Assures rapid and effective communication of data to project teams. 7) Leads or participates in OCP or project sub-teams. Coordinates with appropriate sub-team members and/or prepares summary documentation. 8) Maintains and enhances technical and drug development expertise (e.g. training courses, external meeting attendance). May act as technical subject matter expert in key clinical pharmacology / DMPK related area. 9) Attends meetings with external parties including investigators, outside experts, and health authorities. 10) May manage one or more junior OCP associates. Coaches and mentors other OCP associates.
Ph.D. in pharmacokinetics, drug metabolism or a related discipline, or a Pharm. D. with appropriate post-doctoral training
- 6 - 10 years of relevant post-doctoral, academic, industry or government experience
- Expert knowledge of related disciplines (e.g. DMPK, toxicology, regulatory) and the drug development process
- Demonstrated experience using in silico analysis tools (e.g. WinNonlin, SAS, NonMEM, Trial Simulator, GastroPlus, SymCyp)
- Demonstrated experience and ability to work successfully as part of cross functional team in a highly dynamic, matrixed, project team environment
- Excellent oral and written communication skills • Strong organizational and project skills
- Expert critical thinking and problem solving skills including publications / presentations.
- Strong influencing and negotiating skills
- Coaching, mentoring, and people management skills
Contact email address: firstname.lastname@example.org - 18th Apr 2017 
MedImmune is the worldwide biologics research and development arm of AstraZeneca. Here, you’ll have the opportunity to make a difference in people’s lives every day. As one of the world’s premier biotechnology companies, our mission is centered on delivering life-changing products that advance world health, and help fight and cure disease. As a Senior Clinical Pharmacokineticist or Principal Clinical Pharmacokineticist in Mountain View, CA, you’ll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives.
And we’re excited to share that our work at the Mountain View site (along with some other AstraZeneca Group Companies in the Bay Area) will relocate to South San Francisco by end of 2017. Click here for more information on this new facility.
MedImmune has a dynamic environment that fosters collaboration and innovation. We attract top minds, and we nurture and build top talent.
Main Duties and Responsibilities
You will function as the global Clinical Pharmacology/DMPK (CPD) team representative for biotherapeutic projects at various stages of research and development (target validation through life-cycle management) and be responsible for all aspects of pharmacokinetic/pharmacodynamics (PKPD) -related support for biotherapeutic products, including design of studies, analysis and reporting of data, and communication of data in regulatory documents and meetings. You will also be responsible for providing clinical pharmacology expertise into clinical development plans, including the design, conduct and interpretation of relevant clinical pharmacology studies, including PKPD studies, analysis of data using complex PKPD modelling and simulation methodologies, development and delivery of regulatory strategy (e.g IB/IND, end of phase 2, and BLA) etc, and data analysis and reporting of clinical studies.
Additionally, you will function as the sole point of contact for all CPD activities on projects at all stages of discovery and development and be able to influence team strategy using modelling expertise; Be pivotally involved in assessing and managing analyses of PK/PD data, integrating clinical trial simulation strategies and disseminating the clinically relevant risk/benefit implications to the Company\\\\\\\'s clinical development teams; Collaborate with biostatisticians, clinicians and clinical operation managers for the appropriate design of Phase I-IV studies; contribute to the investigators brochure, clinical study protocol and report analysis and reporting of data, and communication of data in regulatory documents and meetings; Drive clin pharm regulatory strategy for projects at all stages -- IND to BLA -- and defend strategy at regulatory meetings; Help design and conduct translational PK/PD modelling and simulation to support drug design goals, designs of PK/PD and safety assessment studies, and dosing justifications for first-in-human clinical studies; Collaborate with toxicologists on the design, monitoring, and reporting of nonclinical safety studies; prepare TK subreports; comply with good laboratory practice (GLP) regulations for GLP studies. Perform PK analyses for GLP studies per SOPs, record data and analysis results in GLP-compliant manner, ensure timely and clear communication with GLP SD/PI on GLP studies, contribute to GLP study reports; Mentor other junior PK scientists staff on clin pharm science and strategy.
- A doctorate degree in Pharmaceutics/Pharmacy/Engineering/Statistics with demonstrated expertise in PKPD and clinical pharmacology and strong quantitative skills
- Expertise with standard modelling and simulation software (NONMEM, S-Plus/R, etc)
- Knowledge of the use of modelling simulation and its role in discovery and development of therapeutics
- Strong publication and conference presentation track-record
- 5+ years of experience after PhD
- 8+ years of experience after PhD
- Expertise in other modelling software (e.g. MATLAB, Berkeley-Madonna, etc)
- Knowledge of bioanalytical expertise, especially of biologics
- Knowledge of biologics discovery and development - especially knowledge of bioanalytical strategy and GLP
- Proven track record of extensive experience in population modeling and simulations using NONMEM
- Familiarity with statistical software package Splus, R or SAS
- Good communication and scientific writing skills, and ability to independently work in a matrix environment
To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience – it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be a great fit, please share this posting with them.
AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised
13th Apr 2017 
The UNC Schools of Medicine, Public Health, Dentistry, Nursing and Pharmacy comprise one of the nation’s few comprehensive academic health centers located on a world-class research campus.
The Division of Pharmacotherapy and Experimental Therapeutics in the UNC Eshelman School of Pharmacy invites applications for a full-time, fixed term faculty position at the rank of Research Assistant Professor. This Division is a designated Pharsight Phoenix® Center of Excellence, and is a nationally recognized, dynamic and collegial faculty whose vision is to lead the nation in achieving excellence in innovative translational research, education, and progressive pharmacy practice to optimize drug therapy outcomes. The Division has vibrant fellowship and graduate programs, including an NIH-funded T32 postdoctoral training program in Clinical Pharmacology in collaboration with Duke University and the Hamner Institute for Drug Safety Sciences. DPET faculty are in the process of applying to UNC for designation of a new center: The Pharmacometric Center for Precision Medicine. The candidate will be a member of this Center.
The position offers a unique opportunity to work as part of a multidisciplinary team on infectious disease projects focused on the application of mathematical modeling and simulation to characterize drug pharmacokinetics, pharmacodynamics and toxicodynamics.
The successful candidate will work in the laboratory shared by Alan Forrest, PharmD and Gauri Rao, PharmD, MS (computer engineering), MS (pharmacometrics), and will focus on challenging preclinical (in vitro and animal), translational and clinical modeling projects in the areas of antiinfectives (mainly anti-bacterials). The projects will involve the use of nonlinear mixed effects and physiologically-based modeling techniques, and other biostatistical applications in preclinical, translational and clinical drug development research, to identify optimal dosing regimens and laboratory and clinical trial design.
Qualified candidates must have a doctoral degree in Pharmacometrics, Pharmaceutical Sciences, Biostatistics, Biomedical Engineering, Medicine, Pharmacy or a closely related discipline.
The successful candidate must demonstrate expertise in modeling, simulation, and quantitative systems pharmacology. Extensive software (e.g., NONMEM, ADAPT, R) and programming proficiency is preferred.
Excellent communication skills and ability to work independently as well as a member of an interdisciplinary team are essential. Participation in teaching and grantsmanship is also expected.
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, national origin, race, religion, sex, sexual orientation, or status as a protected veteran.
Qualified applicants should apply at http://unc.peopladmin.com/postings/118159 and attach the following materials:
1) a letter of interest addressed to: Dr. Alan Forrest (Search Committee Chair) UNC Eshelman School of Pharmacy 2317 Kerr Hall 301 Pharmacy Lane Chapel Hill NC 27599
2) A complete curriculum vitae
3) The names and contact information for 3 professional references
4) A detailed research project abstract.
External website http://unc.peopleadmin.com/postings/118159
Contact email address: email@example.com - 13th Apr 2017 
Clinical Pharmacometrics at Bayer is now hiring a Senior Modeling and Simulation Expert, to be located in Berlin or Wuppertal (close to Cologne/Düsseldorf), Germany.
If you are a highly motivated, well trained, experienced Pharmacometrician with hands-on modeling capabilities, the following position might be of interest for you:
The Senior M&S Expert at Bayer leads M&S project teams and provides scientific supervision to M&S experts and evaluators. He/she develops and implements state-of-the art population PK/PD M&S methodologies to improve project support in all therapeutic areas and in all development stages. He/she drives, either independently or together with the pharmacometric lead, model-based drug development strategies in order to establish a model continuum by optimizing prospective studies, maximizing the use of available data and ensuring translation of pre-clinical into clinical information. He/she is responsible for the assessment of pharmacological plausibility of population PK/PD M&S results, provides regulatory knowledge in all stages of drug development and ensures compliance with regulations and guidance of regulatory authorities.
We offer a competitive salary in an international environment as well as excellent opportunities for professional and personal development.
If you are interested please use the link to the web posting and online application:
Freundliche Grüße / Best regards,
Dr. Dirk Garmann Head of Quantitative Pharmacology Bayer AG Drug Discovery, Pharmaceuticals Quantitative Pharmacology
31st Mar 2017 
(Senior) Scientist (m/f) PK/PD Modeling & Pharmacometrics MorphoSys AG, Munich, Germany Reference number 154-2016 https://www.morphosys.com/careers/job-opportunities
As one of the leading public biotech companies in Europe, we are committed to developing the medicines of the future. Building on our portfolio of innovative antibody technologies, we are actively pursuing new therapeutic approaches in close collaboration with the world‘s foremost pharmaceutical companies and, increasingly, under our own initiative. Guided by mutual respect and trust, each member of the MorphoSys team is given the opportunity to develop and flourish within this exciting and inspiring environment. Join us in Martinsried near Munich!
- Perform pharmacokinetic/pharmacodynamics (PK/PD) data analyses and develop robust and predictive models for preclinical and clinical projects
- Perform dose/exposure vs. response assessments and population PK data analyses for clinical studies including data interpretation and data reporting
- Interact closely with other members of the team to optimize the design of preclinical and clinical study plans
- Evaluate and interpret regulatory guidelines and project related literature on all PK/PD relevant aspects
- Further expand the companies knowledge on modeling and simulation by engaging with the scientific community and internalize key learnings
- Ph.D. in pharmacology, biology, engineering, mathematics, statistics, or a related field
- Profound expertise in PK and PK/PD data analysis as well as in developing predictive PK/PD models with preferentially two or more years of industry or respective post-doc experience
- Hands-on experience with relevant software (e. g. Phoenix/WinNonlin, Berkley Madonna, R, or equivalent)
- Ability to closely interact with other team members as well as interdisciplinary development teams
- Well-developed communication skills and team-oriented approach
- Excellent command of English and preferably German
External website http://www.morphosys.com
28th Mar 2017 
A Postdoctoral Fellow position is available in the Department of Pharmaceutical Sciences at the University of Oklahoma (OU) College of Pharmacy. The postdoctoral fellow will be involved in collaborative projects using animal models and mechanistic, quantitative systems pharmacology approaches to describe and predict pharmacokinetics and pharmacodynamic responses of various therapeutic agents, with the aim of facilitating translational research and drug development in oncology.
The ideal candidate has a PhD in pharmaceutical/medical sciences, cancer pharmacology, engineering or related fields with a strong publication record. The candidate should have a background in basic pharmacokinetics and hands-on experience with cancer animal models, computational modeling and simulation of pharmacokinetic and/or pharmacodynamic systems and its application to various biological systems using modeling software such as Phoenix, MATLAB, and/or R. Good communication/organization skills with the ability to work in collaborative environment are essential.
The position is jointly mentored by Professors Sukyung Woo and Youngjae You. To apply, please send curriculum vitae, cover letter stating your interest and summary of past research experience, and the names and contact information of three references via email to Dr. Sukyung Woo at firstname.lastname@example.org and Dr. Youngjae You at email@example.com.
OU College of Pharmacy (http://pharmacy.ouhsc.edu/ ) is located in the campus of the University of Oklahoma Health Sciences Center (OUHSC) in Oklahoma City with access to the extensive resources of Peggy & Charles Stephenson Cancer Center and Oklahoma Medical Research Foundation. The University of Oklahoma Health Sciences Center is an EEO/AA Employer.
Contact email address: firstname.lastname@example.org - 28th Mar 2017 
Location: Cambridge, MA
Job Code: CP-CL-0001-17
Job Code: CP-CL-0001-17 Reporting to the Chief Medical Officer, the Clinical Pharmacologist will be responsible for leading scientific and strategic planning, internal and external project communications, and clinical documentation for NDA-directed clinical development programs for H3 Biomedicines drug candidates with an emphasis on clinical pharmacology studies.
Principal Duties and Responsibilities
- Design clinical pharmacology components (pharmacokinetic and pharmacodynamic) of clinical trials in all phases of development.
- Analyze data, interpret results, and author clinicalpharmacology-related clinical documentation, including: clinical protocols; study reports; abstracts and manuscripts; presentations; clinical pharmacology components of investigator brochures, other IND and NDA documents; and various other internal and external documents and communications, as needed.
- Working with Clinical Operations, help develop theoperational strategies for clinical pharmacology studies and development programs - investigator selection, CRO selection, budgets, etc.
- Help manage program timelines for clinical pharmacology components and related matters; and help manage budgets to meet or exceed time, quality and fiscal objectives.
- Assure cross-functional alignment for Clinical Pharmacology studies and activities with other functional areas involved in clinical development programs, within H3B and at intercompany interfaces.
- Minimum requirement: Pharm.D. or Ph.D. in clinical pharmacology, pharmacokinetics, biopharmaceutics or a related field) with 5 or more years of industry experience, including 2 or more years of oncology experience.
- A thorough command of pharmacokinetics and pharmacodynamics and their integration in the clinical drug development process is essential. The candidate must have demonstrated expertise in the design, analysis and reporting of clinical pharmacology studies. The candidate must be competent in the use of industry-standard PK and PK/PD software for noncompartmental, modeling and population-PK and PK/PD analyses and simulation.
- Substantial technical writing experience is essential -documented first authorship of protocols, study reports, regulatory communications, manuscripts, etc. IND and NDA submission experience is
- Familiarity with regulatory issues related to Phase I-II clinical research is essential.
- Excellent communication (verbal and written), presentation,and organizational skills are essential.
- Clinical budget and project management skills are desirable.
H3 Biomedicine Inc. is a privately-held, uniquely-structured oncology discovery enterprise whose sole mission is to become a prolific source of new drugs that treat more human cancers with greater success. H3 Biomedicine is applying the expertise of leading scientists to the integration of insights from cancer genomics with innovative capabilities in synthetic chemistry and tumor biology to pursue the most promising current opportunity in cancer therapeutics: patient-based, genomics-driven, small molecule drugs.
External website http://www.h3biomedicine.com
Contact email address: email@example.com - 3rd Mar 2017 
The position of Director, Quantitative Pharmacology is a technically-driven, high-impact role in Clinical Pharmacology and Early Development (CPED; CMO function), which provides the incumbent an unique opportunity to advance and lead the field of pharmacometrics across the global R and D organization. The appointee will lead pharmacometrics science within R&D, at a portfolio level, spanning the pre-clinical stages through all clinical stages at CSL, working closely with CPED's Directors of Clinical Pharmacology in identifying pharmacometric opportunities and strategy across portfolio to maximize value. The industry-experienced person undertaking this role will have a strong and proven pharmacokinetic/pharmacometrics knowledge, with demonstrable advanced modelling and simulation skills and pharmacostatistical knowledge. Close collaboration with various non-clinical, Research, Clinical R&D, and Commercial Development/Medical Affairs functions will be crucial, as well as strong interaction with world-leading pharmacometric (quantitative pharmacology) experts. The appointee will be required to ensure provision of pharmacometrics support to all R&D projects through the use of internal resources and external alliances, though undertaking hands-on modelling and simulation work on selected crucial projects will also be a requirement.
Doctoral degree with demonstrated expertise in pharmacometrics and strong quantitative skills (e.g. proven experience in most of the following areas: population and PK/PD modelling, mechanistic modelling, systems biology, species scaling methodologies and derivation of first-in-human doses, disease modelling and meta-analyses).
A minimum of 8 years of pharmaceutical industry (or relevant) experience, specifically contributing to pharmacometrics aspects of clinical drug development. In-depth knowledge and experience in advanced PK and PK/PD Advanced pharmacometric knowledge in one of the following core sub-specialty: Systems Pharmacology, advanced Exposure-Response Models, Disease Models, Physiological-Based Pharmacokinetic Models Working knowledge and experience of software such as NONMEM, SAS, S-Plus, R, WinNonlin, and other server-based data processing and modelling tools Knowledge of the role of pharmacometrics in drug development and FDA/ICH requirements for drug registration Knowledge and application of statistics, random effects modelling, mixed effects modelling, data mining, population PK/PD analyses and modelling (including nonlinear models), Bayesian methods, clinical utility indices, and Monte-Carlo simulation Clinical trial design and simulation PK and PD drug interactions, in vivo/in vitro models Ability to understand, lead and implement all aspects of pharmacometrics needs across a variety of disease areas Regulatory and Quality Systems Representation and pharmacometrics leadership at regulatory authority meetings IND, CTA submissions ICH Good Clinical Practice and Good Laboratory Practice EMA and FDA guidelines Quality Control systems and processes for data analytical work to meet Regulatory requirements In-depth knowledge of, and experience with global clinical pharmacology and pharmacometrics regulatory requirements
13th Feb 2017 
The Certara Phoenix Application Engineer will work directly with external and internal customers/clients to provide training, demonstrations, and overall product support. The Application Engineer encourages and strengthens business relationships with customers by providing technical guidance and expertise, supporting sales team efforts, and collaborating with software development teams on product enhancements.
Essential Duties and Responsibilities:
- Responsible for development and delivery of product demonstrations
- Responsible for representing the product to customers and at field events such as conferences, seminars, etc.
- Responsible for visiting customers (alone or with a team) to encourage and support effective use of the products for the benefit of the customer
- Able to articulate technology and product positioning to both business and technical users
- Able to identify all technical issues of assigned accounts to assure complete customer satisfaction through all stages of the sales and support process
- Able to establish and maintain strong relationships throughout the sales cycle
- Able to convey customer requirements to Product Management teams
- Able to travel throughout sales territory
- Able to develop tools, code, and examples that demonstrate the features and benefits of the product for customers
Education and Experience Requirements:
- Master of Science or Doctoral degree (or equivalent) in Computer Science, Engineering, Pharmaceutical Sciences, or similar discipline is required
- 2+ years of relevant experience in customer support, data analysis, or sales
- 1-2 years PKPD modeling experience in graduate studies or industry, does not have to be modeling expert
- Self-motivated with a proven track record in software technology
- Comfortable in the dynamic atmosphere of a technical organization with a customer base that works in a heavily regulated industry
- Must possess strong presentation skills and be able to communicate professionally verbally and in written responses to emails
- Ability to take accountability for projects, problems, and issues, carrying through to resolution
- Ability to influence others through persuasion, support, encouragement, and inspiration.
- Ability to interact with customers and product users to discuss scientific and technical topics related to the software products.
- Must be willing to travel 25% of time (1 – 3 trips per month over 2-5 days)
Please submit your application here - https://workforcenow.adp.com/jobs/apply/posting.html?client=certara&jobId=184559&lang=en_US&source=CC3
External website http://www.certara.com
13th Feb 2017 
Postdoctoral Researcher: Quantitative Systems Pharmacology
Institute of Quantitative Systems Pharmacology (IQSP) - Carlsbad, CA 92008
A postdoctoral position is available in the Institute of Quantitative Systems Pharmacology (IQSP), a nonprofit organization. IQSP works with its academic and commercial partners to promote translational research and instruction in QSP, an emerging field that brings together knowledge in multiple scientific disciplines including biology, physics, chemistry, pharmacology, pharmaceutical sciences, engineering, computational modeling, clinical sciences, and regulatory sciences. QSP aims to increase the cost-efficiency and time-efficiency of drug development, is considered of high importance by NIH and FDA, and represents highly valued skill-sets.
The ideal candidate would have fewer than three years postdoctoral experience, a strong publication record in the field of molecular cancer biology, and expertise of establishing and handling gene manipulated cancer cell and mouse models. Good communication and organizational skills with enthusiasm for translational research are essential. Familiarity of The Cancer Genome Atlas database, experience with pharmacokinetics/pharmacodynamics, and proficiency in quantitative software such as R, SAS and MATLAB is preferred. The successful candidate will work on NIH-funded projects on multiscale models that link receptor signaling events to treatment outcomes.
IQSP is located in Carlsbad/San Diego, CA.
To apply for this position, please send a cover letter, CV and 2 letters of reference to:
Jessie L.-S. Au, Pharm.D., Ph.D., Founding Director, IQSP
Job Type: Full-time
External website http://www.postdocjobs.com/jobs/jobdetail.php?jobid=4019675
Contact email address: firstname.lastname@example.org - 4th Feb 2017 
Regeneron Pharmaceuticals Title: Senior Statistician, Pharmacometrics Location: Tarrytown, NY Req#:7576BR
Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including oncology, rheumatoid arthritis, asthma, atopic dermatitis, pain, and infectious diseases.
These responsibilities of this position will be to: 1) Interact with BDM to generate STDM specifications and validate both SDTM and ADaM data sets 2) Validate the SAS code per study SAP instructions, 3) Validate the PK and PK/PD output files (TFLs). 4) Work with other members in the Pharmacometric function to generate exploratory (ad hoc) Tables and Figures.
This individual will provide SAS programing support, data set creation, validation and management within the clinical pharmacometric function. Working across functional areas with BDM and Clinical Pharmacology, the incumbent will support the creation of SAS code specification from the approved study SAP, and validation of SDTM data set.
From SDTM data set this position will:
- Create and/or validate ADaM data sets
- Create and/or validate NONMEM data sets
- Generate Study Tables, Figures, and Listings (TFLs):
- Create TFL shell based on Study SAP
- Populate TFL from SDTM and/or ADaM Data set
- Validation and finalization of TFLs
- Maintain Pharmacometric SAS Network folder structure
- Support the non-clinical CDISC/SEND data set initiatives
- Bachelors degree +7 years experience or Masters degree +4 years experience
- Prior experience in successful regulatory NDA/BLA submissions.
- Background in creating SDTM and ADaM data sets in SAS.
- Well experienced in SDTM and ADaM data set validation.
- Well experienced Generate and validate TLF.
- Experienced in in generation and validation of NONMEM data sets for Pop PK and PK/PD.
- Experienced in generation of high quality graph in SAS and/or R
- Experienced in creation of exploratory PK and PK/PD data set from LIMS and clinical raw data sets.
- Prior experience in support of Clinical Pharmacology, modeling & simulation, and other pharmacometric activities.
- Proficient in SAS programming.
- Proficient in Excel/ and Excel macro generation.
- Basic understanding of WinNonLin and NONMEM is desirable.
- Basic understanding of biostatistics.
- Highly experienced in data file creation and management.
- Able to take directives and work independently.
- Excellent interpersonal skills.
- Manage multiple programs with competing and aggressive time lines.
Apply today and learn more about Regeneron’s unwavering commitment to combining good science & good business.
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.
External website http://careers.regeneron.com
Contact email address: email@example.com - 25th Jan 2017 
A fellowship opportunity is currently available in the Division of Biochemical Toxicology (DBT) at the National Center for Toxicological Research (NCTR) of the U.S. Food and Drug Administration (FDA).
NCTR conducts FDA mission-critical research specializing in the development of scientific strategies to support regulatory decision-making. DBT focuses on fundamental and applied research designed to elucidate mechanisms of toxicity and support risk-assessment for chemicals of interest to the FDA. The selected participant will work with Dr. Annie Lumen on the development and use of pharmacokinetic and mechanistic models on projects in support of NCTR's objectives and the FDA mission.
Opportunities may include:
- Development of species-specific PBPK and mode-of-action models to investigate the effects of mixtures of thyroid active chemicals on the disruption of the thyroid endocrine system homeostasis, focusing on sensitive life-stages
- Characterizing interspecies differences, and human life-stage specific variability to derive cross-species and intra-population extrapolation strategies
- Simulating combined human exposures and quantitative determination of the cumulative dose-response relationship for relevant endpoints using the developed model
- A Doctoral Degree in biological sciences, toxicology, pharmacology, chemical engineering, applied mathematical sciences, statistics or a related discipline received within the last five years.
- Experience in any modeling and simulation software (e.g., acslX, MCSim, R, Berkeley Madonna, Matlab, etc.) and knowledge of pharmacokinetics and toxicological principles is desired.