PK/PD Postdoctoral Research Associate
Location: University of North Carolina at Chapel Hill, Eshelman School of Pharmacy
Job Description: A Postdoctoral Research Associate position is available immediately to work on projects focused on characterizing the pharmacokinetic/pharmacodynamic properties of Direct Oral Anticoagulants (DOACs). Eventually, work on other therapeutic areas will also be involved. The projects will involve use of nonlinear mixed effects and physiologically based pharmacokinetic modeling techniques to identify patients that require dose adjustment and individualization.
Educational Requirements: PharmD, MD, or PhD.
Qualifications and Experience
- experience in the areas of pharmacokinetics and pharmacodynamics, and applications of biostatistics to these areas
- experience in using nonlinear mixed effects modeling (e.g., NONMEM, Phoenix NLME) and R. Able to work with minimal supervision on assigned modeling projects.
- experience with PBPK modeling software desirable (e.g., Gastro Plus, Symcyp Simulator)
- Publications in well-respected journals and records of high productivity.
- Preference will be given to those who have excellent communication skills and ability to work independently as well as a member of an interdisciplinary team are essential.
The University of North Carolina at Chapel Hill is an equal opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to age, color, disability, gender, gender expression, gender identity, genetic information, race, national origin, religion, sex, sexual orientation, or status as a protected veteran.
Required Documents
Curriculum Vitae /Cover letter /List of References
External website https://unc.peopleadmin.com/postings/159679
Contact email address: robstrat@iu.edu - 19th Jun 201 [2945]
A two-year postdoctoral fellowship in the Disease and Therapeutic Response Modeling and A two-year post-doctoral fellowship is available within the Disease and Therapeutic Response Modeling and Simulation Program, Division of Clinical Pharmacology, Department of Medicine at the Indiana University School of Medicine. The postdoctoral fellow will join our individualized training program in quantitative clinical pharmacology and pharmacometrics, including application of non-linear mixed effects modeling, physiological-based pharmacokinetic modeling, data mining, machine learning, and quantitative systems pharmacology. Trainees will benefit from interactions with the Division’s T32 Clinical Pharmacology Fellowship program, experts in clinical pharmacology, biostatistics, computational biology, and bioinformatics, as well as faculty with long-term experience in the pharmaceutical industry. Candidates will develop the critical skills necessary for participation in state-of-the-art pharmaceutical research, including support of the Preclinical Trial Core of the MODEL-AD Alzheimer’s disease research program. Additionally, the candidate will have the opportunity to support projects in other therapeutic areas of interest, including women’s health, oncology, pediatrics, nephrology, psychiatry, and mechanistic modeling of drug-drug interactions. Candidates are also encouraged to pursue methodological topics relevant to clinical interests of the Program.
Basic Qualifications
Our interdisciplinary team is looking for a motivated, ambitious and creative individual with excellent written and verbal communication skills.
PharmD, MD, or PhD in pharmacology, systems biology/pharmacology, pharmacometrics, bioengineering, biostatistics, computational biology, or related fields.
Preference will be given to candidates with strong quantitative skills and computational experience (R, Matlab, Python, Nonmem, etc); however, candidates with a strong desire to integrate such analyses with pre-clinical and/or clinical drug studies are also encouraged to apply.
External website https://indiana.peopleadmin.com/postings/7843
17th Jun 201 [2944]
Your Role:
The Head of Global DMPK:
- Leads the initiation and execution of Drug Metabolism and Pharmacokinetic (DMPK) aspects of drug projects at the company’s healthcare portfolio across all therapeutic modalities and indications.
- Manages a world leading DMPK department globally. Ensure internal and external resources are fully engaged and developed.
- Manages key external relations for the larger Discovery Technologies team and the company.
- Creates the vision for DMPK and designs the long-term global strategy and operational model for the company’s healthcare research worldwide.
- Ultimate decision-making for all issues associated with pharmacokinetic aspects of drug projects.
- Creates a culture of innovation, entrepreneurship and global, collaborative working
- Assigns resources and budget to all projects on a global basis. Ensures departmental performance in terms of quality clinical candidate delivery.
- Accountable for cutting-edge infra-structure including laboratories, automation and robotics, design tools, electronic lab note-books and collaborative IT tools.
- Initiates and leads external collaborations with major external scientific collaborators. Creates a climate of externalization and external innovation.
- Resolves highly complex business and scientific problems through excellent scientific judgment and broad research, development and commercial knowledge.
- Chairs the global DMPK leadership team. Member of the the company Healthcare’s Discovery Research Committee and the Discovery and Development Technologies leadership team.
- Generation the value of the company Healthcare’s clinical pipeline through quality candidate delivery.
- Allocation of resources, setting strategies, priorities and policies, disseminating best practice and planning of the global DMPK Function.
- Contribution to all in-licensing activities, including clinical-stage assets.
- Involvement to the strategy of drug discovery at the company. Predicts and preempts the company’s pipeline needs in all therapeutic areas.
- Creation synergies and collaborates across the company’s functions beyond biopharma, e.g., Life Science division.
- Ph.D. and/or Post-Doc in drug metabolism, pharmacokinetics, analytical chemistry, synthetic organic chemistry, medicinal chemistry, protein engineering or immunology.
- 10+ years in industry, at least 5 of which in managerial roles in R&D.
- Ideally, experience in both small molecule and therapeutic proteins.
- Demonstrated leadership experience in global organizations.
- Strong track record of clinical candidate delivery and publications.
- Experience in designing high performance DMPK organizations.
- Experience in working with external partners.
- Cross-divisional knowledge and awareness.
- Ability to travel internationally up 20% of the time.
- Fluency in English.
Apply Here: https://bit.ly/2tFVDzv
External website https://bit.ly/2tFVDzv
Contact email address: telder@stem-sourcing.com - 7th Jun 201 [2943]
Director Pharmacometrics
Well established company looking for director and future head of the clinical pharmacology and pharmacometrics department. This role will be an individual contributor primarily in M&S but will have the opportunity to mentor and train junior scientists. This company is working with small molecules, large molecules, SiRNA, and monoclonal antibodies. Let me know if you'd like to learn more.External website https://www.stem-sourcing.com
Contact email address: Cassie.Hauser@synteract.com - 3rd Jun 201 [2942]
Senior Pharmacokinetics / Pharmacokinetic Scientist - Anywhere, US Office-based or Remote-based
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 Senior Pharmacokinetics / Pharmacokinetic Scientist conducts PK/PD modeling and population PK analyses using WinNonLin, NonMem and PKSim with a focus on designing optimal dosing regimens for pediatric patients 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. Be the subject-matter expert on pediatric dosing methodologies including allometric scaling approaches.
Specific tasks would include:
Conduct PK/PD analyses, modeling and simulation in WinNonLin, NonMem and PK-Sim for pediatric patients 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 datasets for import and analysis in WinNonLin.
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.
Qualifications:
Ph.D. in Pharmacokinetics or Pharmaceutical Sciences, plus knowledge of how to support pediatric Pharmacokinetic/Pharmacodynamic modeling and simulations, specifically population PK.
Pediatric knowledge can be gained concurrently through Ph.D. program, as a postdoctoral fellow, or in a professional position.
10% domestic travel to meetings/conferences/client sites
If you’re passionate about bringing clinical trials to life, we encourage you to apply today!
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. The Company will not sponsor applicants [to this position] for work visas.
External website https://www.synteract.com/Careers/Career-Opportunities?gnk=job&gni=8a78879e69b7f0180169bb663e5f1e66
Contact email address: mark.leggas@uky.edu - 28th May 201 [2941]
Colleagues,
The University of Kentucky Department of Pharmaceutical Sciences is recruiting a postdoctoral scholar in pharmacokinetics/pharmacology. The postdoc will participate in an exciting drug development project to further the development of lead drug candidates for the treatment of Ewing Sarcoma. The project involves both research efforts and pre-IND activities. The position seeks a trainee whose primary expertise are in Pharmacokinetics and Drug Metabolism but is willing to extend her/his skillset and incorporate other pharmacology studies such as tumor xenografts for efficacy assessment. Expertise in bioanalytical methods are also desirable but not critical. The post-doc will perform sample preparation, LC-MS instrument maintenance and operation to acquire highly reproducible data and metabolite identification. They will contribute to study design and/or conduct of animal experiments and will perform PK/PD modeling and statistical analysis. The post-doc is expected to work independently but will interface with the PI, senior graduate students, staff, and collaborators.
External website http://ukjobs.uky.edu/postings/220976
Contact email address: zhoumeng@ksu.edu - 27th May 201 [2940]
Job Description: Two postdoc opportunities in PBPK Modeling, Risk Assessment, and Computational Toxicology are available at Kansas State University. The incumbent of the first position will work with Dr. Zhoumeng Lin on PBPK modeling projects at K-State in the first year, and then will move to University of California at Davis to receive additional training in experimental animal techniques and analytical chemistry methods under the mentorship of Dr. Lisa Tell in the second year. The second position will work with Dr. Zhoumeng Lin at K-State on projects related to PBPK modeling, risk assessment and computational toxicology. A PhD in pharmacometrics, pharmacology, toxicology, epidemiology, environmental health, engineering, biostatistics, bioinformatics, or a related field is required.
How to Apply: Please refer to the following webpages for detailed job description and application instructions. Position 1: http://careers.k-state.edu/cw/en-us/job/507327/fellow-post-doc-anatomy-physiology. Position 2: http://careers.k-state.edu/cw/en-us/job/507326/fellow-post-doc-computational-toxicology-pharmacokinetic-modeling. Screening of applicants begins on June 28, 2019 and will continue until the position is filled.
Questions: Please send your inquiry with a copy of updated CV to Dr. Zhoumeng Lin at Zhoumeng@ksu.edu. For more information about Dr. Lin’s research and teaching, please visit his laboratory website (http://www.vet.k-state.edu/education/anatomy-physiology/faculty-staff/faculty/lin/lab/index.html).
Kansas State University is an equal opportunity employer and actively seeks diversity among its employees. Background check is required.
External website https://http://www.vet.k-state.edu/education/anatomy-physiology/faculty-staff/faculty/lin/lab/join_us.html
Contact email address: telder@stem-sourcing.com - 15th May 201 [2939]
Sr. Scientist or Principal Scientist
My client is looking for a clin pharm scientist to work on anti-body programs for oncology. Responsibilities:
- Represent Clin Pharm and M&S on project teams
- Develop pop PK strategies for new and developing compounds
- Participate in the submission of regulatory documents
- Work directly with regulatory agencies on clin pharm projects in development
- PhD/Pharm D or realted degree in PK or pharma sciences
- 3+ years’ experience in industry
- Solid knowledge of DMPK, PK/PD
- Strong background and hands-on experience interpreting clinical dose-response and PKPD data.
- Proficiency with WinNonlin, NONMEM, R, MATLAB, or other modeling software
- Excellent oral and written communication skills and a proven track record of working effectively in a dynamic, collaborative, team-oriented setting
External website https://www.stem-sourcing.com
Contact email address: telder@stem-sourcing.com - 7th May 201 [2938]
Head of DMPK
Small company is looking for a Head of DMPK that is well versed in early stage oncology programs. The incumbent will work primarily with CRO's and provide strategic oversight for all things ADME & DMPK. Incumbent will have full oversight of outsourced PK/PD modeling and simulations.
Small molecule experience is essential and antibody experience is an added bonus. Extensive knowledge of regulatory requirements and GLP, GCP and ICH experience is necessary to be successful in this role.
Please let me know if you'd like to learn more about this exciting opportunity.
External website https://www.stem-sourcing.com
23rd Apr 201 [2937]
PK/PD Postdoctoral Associate
Location: University of North Carolina at Chapel Hill, Eshelman School of Pharmacy
Job Description: A research scientist position is available immediately to work on projects focused on characterizing the pharmacokinetic/pharmacodynamic properties of Direct Oral Anticoagulants (DOACs). Eventually, work on other therapeutic areas will also be involved. The projects will involve use of nonlinear mixed effects and physiologically based pharmacokinetic modeling techniques to identify patients that require dose adjustment and individualization.
Educational Requirements: Pharm.D, MD, or PhD. Salary Range: Dependent on experience and qualifications
Qualifications and Experience
- experience in the areas of pharmacokinetics and pharmacodynamics, and applications of biostatistics to these areas
- experience in using nonlinear mixed effect modeling (e.g. NONMEM, Phoenix NLME) and R. Able to work with minimal supervision on assigned modeling projects.
- experience with PBPK modeling software desirable (Gastro Plus, Symcyp Simulator)
- Publications in well-respected journals and records of high productivity.
- Preference will be given to those who have excellent communication skills and ability to work independently as well as a member of an interdisciplinary team are essential.
External website https://unc.peopleadmin.com/postings/159679
Contact email address: telder@stem-sourcing.com - 18th Apr 201 [2936]
Senior Director, Clinical Pharmacology
Job Description
The Senior Director of Clinical Pharmacology will serve as the Clinical Pharmacology representative on project teams, providing strategic leadership and execution of clinical pharmacology plans that characterize the pharmacokinetic (PK) and pharmacodynamics (PD) properties and drug-exposure relationships for the purpose of optimizing drug regimens. By integrating PK, PD, pharmacogentic, demographic and disease knowledge, the individual will be critical in optimizing and driving insightful drug development plans.
Principal Accountabilities:
- Prepare clinical pharmacology development strategies for multiple small molecule compounds.
- Design clinical pharmacology studies that yield high value PK/PD insight. Analyze PK/PD data and interpret results to maximally impact program goals.
- Drive translational approaches via the clinical development plan from phase 0 to IV.
- Work closely with Research and Clinical Development to fully leverage and integrate the understanding of a compound and its biology.
- Provide expertise and knowledge of translational aspects, including clinical biomarkers and modeling and simulation efforts.
- Develop scientific rationale and concepts for personalized/stratified medicine to optimize patient outcomes.
- Apply strong knowledge of best regulatory practices, technology and development precedent.
- Support regulatory strategy and is responsible for clinical pharmacology sections of regulatory documents.
Skills:
- Has extensive knowledge and practical understanding of current clinical pharmacology within the realm of translational medicine and general drug development.
- Understands and is able to apply appropriate regulatory and ICH guidelines in the design and execution of clinical pharmacology and clinical development plans.
- Experience with immunology drug development is highly desirable.
- Possess strong leadership and excellent communication skills. An ability to manage, mentor and develop direct reports would be an asset.
External website https://www.stem-sourcing.com
Contact email address: gobeaun@mmv.org - 17th Apr 201 [2935]
JOB PURPOSE
Medicines for Malaria Venture (MMV) is a Swiss non-profit foundation whose mission is to reduce the burden of malaria in disease-endemic countries by discovering, developing and delivering new, effective and affordable antimalarial drugs. Working with drug discovery/development partners in academia and industry, as well as with country-based delivery partners and national ministries of health/malaria control programmes, MMV’s focus extends from the identification of new potential treatments for malaria through to clinical development, regulatory approval and delivery-for-impact in malaria-endemic countries. Since its founding in 1999, MMV and partners have brought forward 12 new medicines that have saved an estimated 1.9 million lives.We are currently seeking an Associate Director, PKPD Modelling and Simulation to join our Translational Medicine team. Reporting to the Director in Pharmacometrics, the Associate Director will help speed up the development of treatment to cure patients from malaria or to protect healthy people from malaria while working in a malaria-endemic zone.
PRIMARY DUTIES AND RESPONSIBILITIES:
- Develop innovative models to help the integration of new data and/or new experiments
- Develop PKPD modelling strategy for MMV projects in late discovery and development, undertake and supervise the delivery of the PKPD modelling across MMV’s therapeutic indications
- Develop and apply modelling solutions for monotherapy and combination therapy
- Summarize, interpret and clarify PKPD results to ensure that valuable scientific information is provided in a timely manner to drive team decisions
- Communicate PKPD modelling strategy and results to project teams, MMV management and regulators
- Contribute to establishing pharmacometrics capabilities and infrastructure (eg development of tools for recurrent and consistent analysis, development and implementation of guidance documents and SOPs within the Pharmacometrics Team)
- Provide pharmacometrics components for submission to regulatory authorities
- Author and publish high-quality research articles
- Attend selected conferences for training, giving presentations and posters, representing MMV, and building a network
EDUCATION AND EXPERIENCE:
- Ph.D. in Biomedical Science, Pharmacy, Clinical Pharmacology, Biometrics or Computational Engineering
- At least 5 years of experience (academia and/or industry) with a proven track record within the duties mentioned above
- Published peer-reviewed articles
- Familiarity with the drug development process
- Experience working in a cross-functional matrix
START DATE: As soon as possible
DEADLINE: May 5th, 2019
MORE INFORMATION AND APPLICATION: on https://www.mmv.org/about-us/work-us/jobs#op-318847-associate-director-pkpd-modelling-and-simulation - MMV website
External website https://www.mmv.org/about-us/work-us/jobs#op-318847-associate-director-pkpd-modelling-and-simulation
14th Mar 201 [2934]
SR PHARMACOMETRICS SCIENTIST/DEVELOPMENT SCIENCES @ AXCELLA HEALTH
OVERALL RESPONSIBILITY: br>Axcella Health is seeking a Pharmacometrics Scientist who is well versed in the application of model-based clinical development strategies, in order to describe and understand the pharmacology of our endogenous metabolic modulators. The modeling and simulation activities include population PK/PD models, disease progression models, statistical models, physiologically-based PK (PBPK) models, allometric scaling, quantitative system pharmacology (QSP) models, clinical trial simulations, literature metaanalysis, machine learning/deep learning, and other state-of-the-art quantitative techniques. The candidate will represent the DMPK organization on cross-functional project teams and be an advocate for the use of quantitative approaches to describe the relationship between the known physiology and the observed pharmacokinetics of products.
KEY TASKS AND RESPONSIBILITIES:
- Collaborate with internal and external experts to build population PKPD models for amino acids and contribute to the development of a predictive AXA Development Platform. Our aim is to incorporate drug metabolism and pharmacokinetics knowledge from internal and external sources into a proprietary AXA Development Platform to inform exposure-response relationships and to influence new AXA design.
- Understand and simulate healthy versus disease condition differences to propose dosing regimens for signal seeking studies.
- Undertake diverse scaling approaches to design optimal dosing regimens for pediatric population.
- Conduct biopharmaceutics data analyses (e.g. dissolution performance) with the objective to translate in vitro formulation performance to in vivo formulation performance in humans.
- Organize, execute, and report M&S independently, as well as to present work at crossfunctional teams, department meetings, senior management review committees, regulatory interactions, and scientific conferences.
- Plan, write, and review pharmacometrics aspects in relevant clinical documents such as study protocols, analysis plans, clinical study reports, and regulatory documents.
- Serve as a single point of contact for expert advice on modeling & simulation strategy within Axcella. Collaborate with functions inside and outside of Medical Affairs, including the Product Development Team, to translate available data, summaries, and reports into medical communications and educational resources
- Must have proven experience in quantitative pharmacology and strong hands-on modeling and simulation experience with PK/PD analysis to inform dose selection, safety profile characterization, and product labeling.
- Hands-on experience with population PKPD modeling software (NONMEM, R, SAS, MATLAB, Phoenix, GastroPlus, etc.) is a must.
- In-depth theoretical and applied understanding of PK and PD, in order to describe and understand the pharmacology/biology of amino acids, is required.
- Demonstrated ability to independently plan, organize, and analyze PK/PD data is essential.
- Highly motivated individual with a strong intellectual and technical background in Pharmacometrics discipline
- Excellent problem-solving, written and oral communication skills
Degree in pharmacometrics, pharmacokinetics, pharmacology, pharmaceutical science or related field. PhD with 1- 5 years, or MS with 8+ years of experience in a pharmaceutical industry setting. Experience in modeling/simulation strategies is highly desired. Title/level dependent on experience. If interested, we would welcome a cover letter and CV sent to careers@axcellahealth.com No phone calls please, and only those we will be following up with, will receive a reply
External website https://static1.squarespace.com/static/59c86ca264b05f184cc367e3/t/5c8a5d4e53450a6cd7d01fd1/155257172
14th Mar 201 [2933]
Postdoctoral Fellowship in Pharmacokinetics/Pharmacodynamics
UNC Eshelman School of Pharmacy, University of North Carolina at Chapel Hill
A postdoctoral research position is available immediately to work on projects focused on characterizing the pharmacokinetic/pharmacodynamic properties of drugs used in the pediatric population. The projects will involve use of nonlinear mixed effects and physiologically based pharmacokinetic modeling techniques to identify optimal pediatric dosing and clinical trial design.
Educational requirements: PharmD, MD, or PhD with knowledge of pharmacokinetic/pharmacodynamic analyses.
Preferred experience: demonstrated software proficiency (e.g., NONMEM, R) is preferred. Excellent communication skills and ability to work independently as well as a member of an interdisciplinary team are essential.
Interested applicants should submit a letter describing personal goals as they relate to the position, Curriculum Vitae, and 3 professional references at https://unc.peopleadmin.com/postings/153424.
External website https://unc.peopleadmin.com/postings/153424
Contact email address: gobeaun@mmv.org - 12th Mar 201 [2932]
Job Purpose
Medicines for Malaria Venture (MMV) is hiring a PKPD post-doctoral fellow for 3 years. The position is based in Geneva, Switzerland.
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 post-doctoral fellowship will provide a PhD graduate with the opportunity to expand their scientific knowledge and skills. Working under the direct supervision of a senior pharmacometrician, the successful candidate will have the opportunity to see how pharmacometric approaches (PBPK and PK/PD modeling and simulation) are used to speed up the drug development process, from early to late stage. They will also contribute to the development of innovative modeling approaches to help the interpretation of in vitro data, the translation from preclinical to clinical, and dose selection for clinical studies. Following this experience, the fellow will be well-equipped to accept opportunities in academia, industry or other R&D product development partnership organizations.
Primary Duties and Responsibilities
- Provide PKPD modeling expertise to preclinical and clinical projects to help speed-up the development of molecules for antimalarial treatment or chemoprevention
- PK/PD analyses of non-clinical and clinical studies, especially of combinations of new antimalarial compounds
- Further develop skills in areas such as:
- Preclinical in vitro assays and in vivo experiments used to make first human predictions
- Formulation development
- PBPK analyses
- Clinical development
- 20% of time will be allocated to a specific research project, supporting MMV?s strategy, to develop an innovative PKPD modeling approach
- Author and publish high quality research articles
- Attend selected conferences for training, giving presentations and posters, representing MMV, and building a network
More information https://mmv77988.recruiterbox.com/jobs/fk0jdsl
Deadline: 7 April 2019
External website https://mmv77988.recruiterbox.com/jobs/fk0jdsl
Contact email address: broseberry@cartermackay.com - 6th Mar 201 [2931]
Director, clinical pharmacology role available
- Provide global development science and strategic expertise to projects within a specific TA. Provide regulatory expertise for clinical pharmacology registration within a specific TA
- Have thorough understanding of exploratory development, clinical methodologies, POC, and clinical endpoints within a specific TA
- Provide creative clinical pharmacology input for profiling of compounds to enable successful commercial differentiation
- As a global clinical pharmacology lead for phase 3 programs, will ensure efficient delivery of clinical studies within a TA, under the responsibility for registration
- Provides disease area expertise and opportunities for scientific contributions to the team
- Oversees interpretation of complex data, provides leadership in model based drug development, introduces state-of-art translation medicine strategies, platforms and methodologies
- Defines and maintains a leading overall exploratory development and clinical pharmacology strategy.
Provides appropriate clinical pharmacology scientific input on licensing opportunities. - Contributes to the preparation of the capacity and budgetary information related to approved development projects, maintenance and marketing support projects, infra- structural projects and/or departmental activities
- Contributes to the definition, implementation and maintenance of new multidisciplinary ways of working in order to improve the efficiency and effectiveness of clinical pharmacology
- Be the Global Clinical Pharmacology Lead for in-house discovered or in-licensed compounds.
- This requires leading a cross functional team of 15 -- 25 experts in toxicology, pharmacology, translation, Clinical Pharmacology Operations. Responsible for delivery of Exploratory Development strategies to Proof of Concept or Clinical Pharmacology strategies through registration
- Be involved in the design, analysis, and reporting at least 3 to 10 clinical studies per year
- As a clinical pharmacology lead, provide the scientific lead for a cross-functional team of 15 - 25 people
- Responsibilities may directly impact on strategy and efficiency of clinical development of compounds.
- Has responsibilities for contributing to the overall annual budgeting and assessment of resources for assigned projects for executing clinical pharmacology strategy from FIM to registration
- Has responsibilities that directly impacts on strategy and efficiency of clinical development of compounds, especially in the early and late phases.
External website https://www.cartermackay.com
Contact email address: broseberry@cartermackay.com - 5th Mar 201 [2930]
AD/Director Clinical Pharmacology and M&S
Essential Functions:
- The Director of Clinical Pharmacology is accountable for planning and integrating clinical pharmacology studies, which meet standards of excellence, ethical, regulatory, and legal requirements, into overall clinical development program objectives. The Director ensures that clinical pharmacology studies meet agreed timelines and budget and deliver pivotal, decision-making knowledge for the programs.
- Contributes to functional excellence in science, including population modeling and simulation applications in drug development and regulatory science. Maintains contact and establishes strong reputation with the external scientific community through publications and other initiatives.
- Defines resourcing and outsourcing strategy for the operational aspects of clinical pharmacology and external collaborations in modeling and simulation. Directly oversees critical path activities with external artners.
- Manages Associates/Assistants, including responsibility for staff recruitment, development, coaching, mentoring, and performance management.
- Serves as internal consultant for all development teams.
- Defines future directions for Translational Medicine, especially in areas related to novel methodology in clinical science and pharmacometrics.
- A Ph.D. degree in pharmaceutics or Pharm D is preferred.
- 10-15 years+ experience in drug development science, including drug metabolism, PK, PK/PD, biomarkers, writing and regulatory interactions.
- Clinical Pharmacology Study Planning - Thorough understanding and experience in the planning and execution of phase 1 volunteer studies (i.e., clinical trial management of phase 1 studies); Experience with multiple phase 1 units that concentrate in; special populations (elderly, pediatric) RI-AME, First in Man, Impairment, PET/EEG and DDI; Knowledge of clinical pharmacology study requirements including protocol input, CSR?s, and other program documents.
- Cutting-edge knowledge of pharmacometric science and regulatory applications of modeling a simulation in drug development.
- Excellent communication and negotiation skills; Ability to function in a cross-cultural environment.
- Exceptional interpersonal skills (globally, internally and externally).
High level of initiative and ability to work independently under minimal supervision. - Proven ability to support innovation even if taken outside of his/her comfort zone; Demonstrated pragmatism and willingness to drive and support change; Demonstrated ability to challenge established practices and concepts.
Contact email address: broseberry@cartermackay.com - 5th Mar 201 [2929]
Help apply quantitative analysis methods and PK/PD modeling techniques in developing candidate drug products through clinical development. Serve as an expert to all relevant disciplines and ensure that modeling and simulation (M&S) methods are utilized optimally in development activities. Plan and execute PK/PD M&S activities. Represent the Pharmacometrics group in project team meetings, collaborating with others on the principles and theories of quantitative evaluation of new products. In collaboration with other members of project teams, make decisions impacting PK/PD analysis goals and the success and relevance of individual studies. Contribute to the design and preparation of pharmacokinetics development strategies and study protocols, performing and supervising pharmacokinetic and pharmacodynamic analyses, and preparation of clinical study reports and integrated summary documents. Provide feedback and direction for regulatory submission preparations and review support for new or existing products. Work closely with clinical operations, biostatistics, data management, research, drug metabolism, and therapeutics areas. Contribute to the development and implementation of guidelines and SOPs within the Pharmacometrics group. Provide scientific/technical guidance, leadership, and decision-making as appropriate. Provide regular performance feedback, development, and coaching to direct reports.
Requirements: A minimum of PhD in pharmacokinetics/pharmacodynamics, pharmacometrics, or related field is required. A minimum of 8 years of experience in designing, analyzing, and reporting drug development studies is required. Equivalent experience may be accepted.. Proficiency in the use of major PK/PD software such as WinNonlin, Monolix, or NONMEM is required, as is working knowledge of software used to create graphical output and report study results. Strong written and verbal communication skills are required; must be able to independently create high quality written reports and summary documents for use in regulatory submissions. Desire to work in a cross-functional drug development team environment with all levels of employees and management is valued. Must be goal-oriented, quality-conscientious, and project-focused, with demonstrated ability to develop successful influential relationships with colleagues, both internal and external. Please email me at broseberry@cartermackay.com for more info or call at 315-415-4353
Contact email address: broseberry@cartermackay.com - 5th Mar 201 [2928]
Two openings?one in CA one in MA:
Scientist through Associate Director level:
Requirements: A Ph.D. in Pharmacokinetics, Pharmaceutical Sciences, Pharmacology, Biomedical Engineering or related discipline. Level commensurate with experience Relevant PKPD experience and demonstrated impact on drug development and/or the PKPD scientific landscape.
Preferred qualifications: Strong knowledge and experience in either oncology, immunology, and/or tumor immunology 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, SimBiology, etc) and the ability to analyze and critically assess PK/PD data is essential.
The candidate should have experience working on cross-functional teams, demonstrate excellent communication skills, and have the ability to work independently and effectively. Please contact me for more info at broseberry@cartermackay.com Upcoming/recent grads/postdocs are welcome to apply
Contact email address: telder@stem-sourcing.com - 5th Mar 201 [2927]
Senior Vice President of Pre-Clinical Development
Specific Responsibilities: Lead the design and implementation of IND and BLA enabling pharmacology, toxicology, pharmacokinetic, and biodistribution studies (GLP and non-GLP) Lead the selection and management of contract research organizations (CROs) to support pre-clinical development programs Drive the continual improvement of pre-clinical development process Work closely with other functional areas and colleagues to ensure that all pre-clinical studies are performed in a quality, timely and scientific manner Write and edit preclinical study reports Participate in preparation for and discussions with regulatory agencies to obtain feedback on pre-clinical development programs Requirements Position Requirements & Experience Expertise in pre-clinical drug development, GMP and FDA requirements Expertise in drug delivery and working with multiple drug target tissues, i.e. skin, retina, bone marrow, brain, liver, lung, etc. Minimum 7 years of management experience Excellent project management and written & oral communication skills Experience with engineered cellular medicines is preferred Scientific degree desired: Ph.D. or M.D. or M.S.., and M.B.A. is a plusExternal website https://www.stem-sourcing.com
11th Feb 201 [2925]
Model Answers R&D is a growing consultancy business dedicated to help pharmaceutical and biotech companies make successful drug development decisions. We continue to expand the team and are looking for an R programmer to support modelling and simulation activities in the company. A brief description of the opportunity can be found below, with more information on the company found on our website (www.model-a.com.au). If you would like to speak to a member of the Exec Team about this position, please contact Mike Cheng (Associate Director - Data Science), or Gillian Corlass (Business Support & Quality Manager). All formal applications must be made via recruitment@model-a.com.au
Role: R programmer with demonstrated experience with R and ability to write well documented reusable code. Tertiary qualification in IT, math or science related field required. Critical thinking, problem solving and analytical skills preferred. Strong communication skills and attention to detail, excellent organisational skills.
Location: Brisbane, Australia
External website https://www.model-a.com.au
Contact email address: annie.lumen@fda.hhs.gov - 1st Feb 201 [2924]
PBPK Modeling Fellowship (ORISE) Division of Biochemical Toxicology National Center for Toxicological Research U.S. Food and Drug Administration Jefferson, AR
Project Description:
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 a dedicated mentor on the development and use of pregnancy Physiologically Based Pharmacokinetic (PBPK) models to investigate the challenges and opportunities in modeling life-stages in support of NCTR?s objectives and the FDA mission. Opportunities may include:
- Development of PBPK models for case study compounds to investigate the diverse effects of pregnancy on drug pharmacokinetics.
- Characterizing population variability and propagation of parameter uncertainties in pregnancy PBPK modeling.
- Evaluating the utility of machine learning methods for handling model input specifications.
This program, administered by ORAU through its contract with the U.S. Department of Energy to manage the Oak Ridge Institute for Science and Education, was established through an interagency agreement between DOE and FDA. The appointment is full-time at NCTR in Jefferson, Arkansas. Participants do not become employees of FDA.
Qualifications:
- A Doctoral Degree in pharmacology, toxicology, applied mathematical sciences, chemical engineering, statistics or a related discipline received within the last five years.
- Experience in programming languages and any modeling and simulation software (e.g., R, acslX, MCSim, Berkeley Madonna, Matlab, Simcyp, Gastroplus etc.) and knowledge of pharmacokinetics and toxicological principles is preferred.
To be considered, please send a current CV/resume to the attention of annie.lumen@fda.hhs.gov.
Contact email address: telder@stem-sourcing.com - 1st Feb 201 [2923]
SCIENTIST / SR SCIENTIST ? DMPK CLINICAL PHARMACOLOGY OVERALL RESPONSIBILITY: The DMPK team seeks an experienced Scientist/Sr. Scientist to provide DMPK support to the research and development team. The ideal candidate will be highly skilled in conducting DMPK studies and data interpretation, and characterization of the Axcella products. He or she will serve as a DMPK representative in interdisciplinary collaborations and communicate conclusions, progress, and plans at internal meetings. Hands-on PK/TK analysis, PK/PD, PB/PK or other modeling technique is highly desirable.
KEY TASKS AND RESPONSIBILITIES:
- Incorporate DMPK modeling and simulation capabilities in planned clinical studies
- Independently design, execute and interpret DMPK studies (preclinical and clinical) to investigate PK/PD of AXA amino acids
- Assist in the management of external DMPK (preclinical and clinical) and Toxicology studies by providing tactical resolutions to scientific challenges
- Contribute to PK/PD sections of clinical study protocols and regulatory documents (e.g. IB and IND)
- Study execution and documentation under GxP environment (PK/TK analysis)
- Hands-on PK/TK, PK/PD and PB/PK analysis and prediction using diverse modeling techniques (Phoenix, G+, Simcyp, R, NONMEM, etc.)
- Highly motivated individual with a strong intellectual and technical background in DMPK/Clinical Pharmacology discipline
- Proven ability to independently perform high quality research and work effectively on multifunctional teams
- Experience in the conduct of early clinical studies from PK perspective is highly desired
- Excellent problem-solving abilities
- Excellent written and oral communication skills
External website https://www.stem-sourcing.com
Contact email address: telder@stem-sourcing.com - 29th Jan 201 [2922]
Associate Dir. or Dir. of Clinical Pharmacology/Pharmacometrics
Well established company looking for AD or Dir of Clinical Pharmacology with previous hands on experience with pop pk (NONMEM). This candidate will manage pop pk CRO\\\'s and have oversight of modeling studies while not actually being responsible for M&S on-site. Ph.D with 10+ years of experience. Senior Director title is not an option for this role.External website https://www.stem-sourcing.com
Contact email address: telder@stem-sourcing.com - 23rd Jan 201 [2921]
Sr. Dir. Clinical Pharm/DMPK
Key Responsibilities
Responsible for scientific and budgetary responsibility for the design, execution, analysis, interpretation and reporting of clinical pharmacology related studies including first-in-human, drug-drug interaction, biopharmaceutics and ADME studies. Develop and execute clinical pharmacology strategies in collaboration with internal and external partners to advance drug candidates in an efficient and scientifically rigorous manner. Lead cutting edge science, creativity, and novel approaches in clinical pharmacology and related areas. Lead and develop a team of Clinical Pharmacologists, in addition to providing oversight for work conducted by CROs. Represent clinical pharmacology in project teams and in regulatory interactions including preparation of regulatory documentation and participation in meetings with regulatory agencies. Minimum Requirements
PhD in clinical pharmacology, pharmaceutical sciences or related areas such as pharmacokinetics, pharmacology or drug metabolism with at least 12 years of relevant experience in drug development. Exceptional Masters or Bachelor?s candidates with demonstrated proven experience will be considered. Must demonstrate the aptitude and experience to lead a clinical pharmacology group and effectively manage professional staff. Extensive experience in formulating and executing clinical development strategies including design, interpretation and reporting of clinical pharmacology studies is required. A working knowledge and previous experience with pharmacokinetic/pharmacodynamics, drug-drug interactions, PKPD data management/analysis, and experimental medicine is also needed. Broad familiarity with the drug development process, particularly for oncology, is highly desirable as is prior experience working with CROs.
External website http://www.stem-sourcing.com
Contact email address: lgraham@kinderpharm.com - 23rd Jan 201 [2920]
Associate Director Pharmacokinetics / Pharmacokinetic Scientist Department: Pharmacokinetics Location: Exton, Pennsylvania Contact: Lynda Graham, MBA lgraham@kinderpharm.com
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 Conduct PK/PD modeling and population PK analyses using WinNonLin, NonMem and PK-Sim with a focus on designing optimal dosing regimens for pediatric patients 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. Be the subject-matter expert on pediatric dosing methodologies including allometric scaling approaches.
Job Duties & Responsibilities
- Conduct PK/PD analyses, modeling and simulation in WinNonLin, NonMem and PK-Sim for pediatric patients 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 datasets for import and analysis in WinNonLin.
- 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. in Pharmacokinetics or Pharmaceutical Sciences
- Non-compartmental (NCA) and compartmental PK analysis is Phoenix WinNonLin-PKSo
- Knowledge of how to support pediatric Pharmacokinetic/Pharmacodynamic modeling and simulations as follows:
- PK/PD analyses, modeling and simulation in WinNonLin
- Population PK using NonMem
- Physicological Based PK using PKSim, GastroPlus or SimSyp
- Pediatric knowledge can be gained concurrently through Ph.D. program, as a postdoctoral fellow, or in a professional position
- 10% domestic travel to meetings/conferences/client sites.
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.
External website http:// kinderpharm.com
Contact email address: jdumond@unc.edu - 18th Jan 201 [2919]
A Research Assistant Professor position is available immediately 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 and pharmacodynamics. The projects will involve the use of nonlinear mixed effects and physiologically-based modeling techniques, and other biostatistical applications in preclinical and clinical drug development research, to identify optimal dosing and clinical trial design. The successful candidate will work in the Clinical Pharmacology and Analytical Chemistry Laboratory of Dr. Angela Kashuba, and will focus on challenging preclinical and clinical modeling projects in the areas of HIV treatment, prevention, and cure. This position is also integrated into the UNC Center for AIDS Research, the HIV Cure Center, and Qura Therapeutics. The candidate will also consult on, and assist with, projects supported by these entities. This candidate will become part of the Division of Pharmacotherapy and Experimental Therapeutics. 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 Institute for Drug Safety Sciences. It is expected that the successful candidate will embrace student mentoring. Didactic teaching is not required, but there are many opportunities to participate if the candidate wishes to grow their teaching portfolio. At UNC-CH, 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. This creates an excellent environment in which to conduct multidisciplinary research. This position will work within dynamic multidisciplinary teams to optimize drug dosing and outcomes.
Qualified candidates must have either a doctoral degree in Pharmacometrics, Pharmaceutical Sciences, Biostatistics, Biomedical Engineering, Medicine, Pharmacy or a closely related discipline, or a masters of science degree with additional pharmacometrics training. The successful candidate must demonstrate expertise in modeling, simulation, and statistical methods through evidence of scientific meeting presentations, publications, regulatory report submissions or other equivalent activities.Extensive software (e.g., NONMEM, ADAPT, Phoenix, Simulations Plus Suite, 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. Interested applicants should submit a letter describing personal goals as they relate to the position, along with a curriculum vitae.
External website https://unc.peopleadmin.com/postings/154869
17th Jan 201 [2918]
UNC/GSK Postdoctoral Fellowship in Pharmacokinetics/Pharmacodynamics
The UNC Eshelman School of Pharmacy and GlaxoSmithKline (GSK) offers a two-year postdoctoral fellowship in pharmacokinetics/pharmacodynamics (PK/PD). The fellowship emphasizes coursework and hands-on experience focused on the application of population and physiologically-based PK/PD modeling and simulation techniques to guide drug development. Fellows spend their first year in Chapel Hill, NC at the University of North Carolina, and the second year at GSK research facilities in Collegeville, PA.
At the completion of the Fellowship, the post-doctoral fellow will be able to:
- Describe the importance of clinical research in drug development;
- Describe the nature and relevance of clinical data evaluations relative to drug development;
- Design and implement studies to examine drug absorption, drug disposition, pharmacodynamic endpoints and drug interactions in healthy human volunteers or diseased patient populations;
- Understand foundational concepts related to population PK/PD and physiologically-based PK modeling and simulation techniques;
- Understand important considerations in clinical trial design and the conduct of clinical investigations in specific patient populations (e.g., pediatrics);
- Perform PK/PD and statistical data analysis using relevant software packages;
- Prepare a manuscript, seminar and other scholarly vehicles for communication of scientific results.
External website http://pharmacydpetfellowships.web.unc.edu/
Contact email address: valva@cop.ufl.edu - 16th Jan 201 [2917]
Job description: The Center for Pharmacometrics and Systems Pharmacology (CPSP) in the Department of Pharmaceutics (PC) at the University of Florida College of Pharmacy (COP) on the Lake Nona (Orlando) campus invites applications for a Postdoctoral Research Fellow position. The successful applicant will have demonstrated expertise in Quantitative Clinical Pharmacology and will join the CPSP to develop state-of-the art mechanistic models. Demonstrated experience in system pharmacology and/or physiologically-based pharmacokinetic modeling and population pharmacokinetics/pharmacodynamics will be considered as an advantage.
The Center?s mission is to advance drug development and regulatory science through innovative translational research, education and scientific multidisciplinary collaborations with industry, FDA, NIH, academia, foundations, and other public entities, with a focus on biosimulation.
Minimum Requirements: The successful applicant will hold a Ph.D. with training in applied quantitative clinical pharmacology. FDLE Criminal Background Check Required.
Preferred Qualifications: The successful applicant will have experience in the area of systems pharmacology and/or PBPK and/or pop PK/PD modeling and simulation. Soft skills are essential to team-based research, and in order to provide clear verbal and written communication between, trainees, faculty, and external collaborators. Regulatory or industry experience is an added attribute for the successful candidate provided that a thorough understanding of drug development and regulatory decision making process is helpful for successfully working in the highly collaborative environment of the Center and its partners.
Special Instructions to Applicants: The Search Committee will accept applications until the position is filled. Application will be reviewed starting end of January, 2019. Interested applicants should apply by email at valva@cop.ufl.edu and submit: (1) a letter of interest; (2) complete curriculum vitae; and (3) contact information for at least three professional/academic references. Three letters of recommendation will be required for final candidates.
Questions may be directed to Valvanera Vozmediano, valva@cop.ufl.edu.
Contact email address: lwilken@lilly.com - 15th Jan 201 [2916]
At Lilly, we unite caring with discovery to make life better for people around the world. Due to strategic dedication to the growth of biotechnology, we are seeking an experienced ADME scientist to work in a highly collaborative team environment. Are you looking to grow in your career and contribute at a high level to our strong pipeline of therapies? Can you apply your diverse analytical tools to characterize and optimize factors influencing the absorption, disposition, and pharmacodynamic properties of biologic therapeutics in development as drug entities? The Biotechnology Research/ADME team works closely with toxicology, discovery biology, protein engineering and multiple therapeutic areas as part of a collaborative effort to advance peptides, proteins, and monoclonal antibodies to clinical testing. Lilly offers a unique and dynamic research environment where our teamwork and contributions are valued and recognized. Our patients are waiting. Are you interested in leading key research that will make an impact on the lives of people around the world?
In this role you will be responsible for:
Oversight of study design and execution for non-clinical PK and PK/PD studies, TK studies. Function as a project leader in a multidisciplinary team environment with primary responsibility for the early preclinical development of antibodies and protein molecules. Integrate pharmacokinetics and PK/PD with discovery biology to define structure activity relationships guiding protein engineering strategies and optimization of protein therapeutics. Interact across groups, including other departments, regulatory agencies, and functional teams within drug disposition. Lead preparation of relevant sections of regulatory documents for development and registration of new drugs and line extensions; interact with regulatory agencies worldwide. Lead, coach and mentor the technical work of junior scientists. Collaborate with scientists in academia. Excellent written and oral communication of scientific data, both internally and in the scientific community
Company Overview
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 39,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We?re looking for people who are determined to make life better for people around the world.
Basic Qualifications
Ph.D. in Biochemistry/Biology/Cell Biology or a related discipline in Pharmaceutical Sciences. At least 5 years of experience in the development of monoclonal antibodies, peptides/proteins or fusion proteins preferably in industry (Pharma/Biotech).
Additional Information
Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
Additional Skills/Preferences
Experience with oral protein delivery strategies, development and implementation of animal models for oral peptide delivery. Industry (pharma, biotech, CRO, etc.) experience with PK/PD modeling. Working knowledge of immunoassay and/or LC/MS bioanalytical methodology. Experience with drug development and knowledge of regulatory processes. Working in an interdisciplinary team. Proven ability to identify scientific issues and tackle problems, both individually and with collaborators in other functional areas. Ability to influence, negotiate and communicate with partners in both internal and external organizations.
External website http://bit.ly/45806_Lilly