Hughes & Associates

Description

In this role, the individual will have the responsibility to lead the clinical pharmacology development of  Immunology Diseases programs in full development and life cycle management, and to contribute to the design, planning, execution and interpretation of studies conducted in early clinical (Phases I, II and III) development. This individual will manage the clinical pharmacology profiling and all Pharmacology aspects for Oncology diseases areas. Experience in biologics and small molecule drug development .  Must have excellent oral and written communication skills along with expertise in M&S software NONMEM, etc…

Qualifications

Requirements for the position include a Ph.D. in pharmacology or pharmacokinetics or a PharmD with a clinical pharmacology research fellowship with at least 5 years experience.

If interested please reply with your updated CV, along with questions and commnets to jchapman@haallc.com

Key Responsibilities:

• Designs and executes PK/PD experiment with the project team members
• Performs PK/PD analyses for preclinical experiments
• Demonstrates astute understanding of the PK/PD field and the relevant literature
• Develops and validates mathematical PK/PD models independently for various projects
• Performs advanced and/or complex troubleshooting for mathematical models
• Utilizes preclinical data for human efficacious dose prediction
• Demonstrates effective, self-sufficient communication skills, especially in peer-directed presentations

Minimum Qualifications

• PhD in pharmacometrics or pharmaceutical science or other science degree
• Proficiency in PK/PD modeling software, such as WinNonlin, Adapt II

If you have an interest with this position please feel free to reply with your comments, questions and CV to jchapman@haallc.com

The successful candidate will conduct PK/PD and PK/efficacy modeling as well as human PK prediction during late stage lead optimization through early pre-clinical development, and collaborates in PK/PD and efficacy study design. The successful candidate will be responsible for communication of experimental results from DMPK throughout the project teams, be a DMPK point of contact, and key contributor toward PK/PD strategy. The candidate should be able to mentor and manage personnel, meet critical deadlines and have an interest with independent designs of complex PK/PD strategies.

Minimum educational requirements PHD in Pharmacokinetics with hands on Modeling skills in an industry setting for at least 7-10 years.

If you would like to be considered please send your comments, questions and CV to jchapman@haallc.com

The pharmacokineticist in the clinical pharmacology group plays a central role in both clinical pharmacology and support of nonclinical development Working within the clinical development organization, the Senior Scientist supports multiple programs through participation on internal project working teams and serves as a liaison between chemistry, life sciences, regulatory and clinical operations.  A strong background in pharmacokinetics and modeling, clinical pharmacology, nonclinical ADME, and bioanalytical chemistry, combined with excellent leadership and communications skills are essential in this dynamic role.

A PhD in Pharmacology or Pharmaceutical Science – with a Focus on PK/PD or PharmD with 3 or 4 years of experience is required.Demonstrated experience with compartmental modeling and non-compartmental analysis required (WinNonLin); experience with NONMEM, population pharmacokinetic analyses, pharmacometric/PK-PD modeling a plus!

Interested? Please send your CV to jchapman@haallc.com and I will contact you about your career advancement interests.

Description
- In this role, you will lead the design, analysis, interpretation and reporting of pharmacokinetic, drug disposition, and drug metabolism data from clinical studies for compounds in immunology diseases utilizing state of the art technology in support of clinical development plans.
- You will perform pharmacokinetic and pharmacodynamic modeling, contribute to PK related regulatory documents and draft PK sections in support of clinical development plans, and provide PK perspective on cross functional teams.
- You will also participate in regulatory interactions as needed as well as evaluate feasibility of clinical studies and provide input to the design and review of clinical protocols.
- In addition, you must be at the forefront of scientific literature in the areas of drug metabolism, pharmacokinetics pharmacodynamics and clinical pharmacology.

- You will also serve as a mentor to junior level PK scientists.

Qualifications
- Requirements for this position include a Ph.D. or a PharmD with a postdoctoral fellowship in Pharmacokinetics, Biopharmaceutics or a related field with a minimum of 3 years experience in pharmacokinetic, pharmacodynamic and drug metabolism techniques; industry experience is preferred.

- Direct experience designing, conducting and interpreting studies in population PK, PK PD correlations, modeling and simulation utilizing state of the art applications is required.
- Experience in modeling and simulation techniques, data interpretation and their application to the drug development process is highly desired.
- Candidate must display strong written and oral communication skills necessary to deliver scientific presentations.
- The ability to work in a dynamic team oriented environment as demonstrated by participating in and contributing to cross functional teams is necessary. Experience in building an internal network of collaborators is desired.

If you have an interest with this position please send you CV or resume to jchapman@haallc.com

Associate Director

Job Responsibilities

Assists the Senior Director, Clinical Pharmacology for all clinical pharmacology aspects, including:
-Development of protocol outlines, protocols, pre-study, during study and post-study clinical activities
-PK/PD study design and analysis, PK/PD reports, and Executive Summaries for PK/PD studies.
-Population PK/PD design, analysis and reporting (Pharmacometrics).
-PK/PD modeling and simulation; Clinical trial modeling and simulation
-Clinical Pharmacology sections of GDCPs
-Relevant sections for regulatory filing of Investigational New Drugs and New Drug Applications.
-Defense of regulatory submissions
-Biopharmaceutics involving formulation development, dissolution testing, in vivo – in vitro correlations for pre- and post-NDA formulations.
-Supporting corporate and departmental goals.
-Serving as project leader for project teams
-Serving as team member on key projects as needed.

Skills

Must be able to apply scientific knowledge in the areas specified above to further the company’s products, anticipate and identify core problems, apply insightful analysis, and solve problems effectively, have strong organization skills, have excellent verbal and written communication skills and the flexibility to react rapidly to changing situations/environment.

If you are interested with the unique opportunity of creating a M&S capability in a Pharmaceutical company please send your CV to jchapman@haallc.com

Job Description:

• Represents clinical pharmacokinetics on clinical study management teams
• Works closely with scientific leads in Translational Medicine to design, write and implement the pharmacokinetics components of clinical protocols and integrates drug metabolism data and toxicology data into rational Phase 1 study design
• Works closely with internal Phase 1 Study Managers to oversee conduct of Phase 1 studies and with Phase 2/3 Study Managers to oversee operational components of the PK elements clinical studies, including acting as the liaison with bioanalytical CROs
• Performs appropriate PK data analysis, interpretation and reporting of all PK data for all clinical studies
• Participates in the selection and management of CROs for clinical study conduct and bioanalytical services
• Works closely with Project Management to ensure timely completion of Phase 1 studies
• Reports to the Director of Drug Disposition and Response in Translational Medicine

A Pharm.D. or Ph.D. in pharmaceutical science or other relevant program plus 5 years clinical pharmacology experience in a biotech or pharma industry environment Or MS level with 8 years industry experience.

Please reply with your updated CV or Resume to jchapman@haallc.com