Senior Manager, Pharmacokinetics, Dynamics & Metabolism 9/8/2016
A New Beginning - Genesis 2
JOB DESCRIPTIONAPPLY SENIOR MANAGER, PHARMACOKINETICS, DYNAMICS & METABOLISM
Support project teams as a modeling and simulation (M
Conduct PK, population PK, PK/PD analysis, clinical trial simulation, and/or PBPK analysis;
Formulate and execute PK/PD and M
Develop and review protocols, analysis plans, and study reports for M
Prepare IB/IMPD/IND and other regulatory documents, when needed.
DEVELOP THE FOLLOWING SCIENTIFIC SKILLS:
Perform population PK and PK/PD analysis, clinical trial simulation, and/or PBPK analysis under minimal supervision;
Perform compartmental PK analysis and simulation;
Perform complex non-compartmental PK analysis;
Apply a logical and structured approach to file management;
Accurately and fully record pharmacokinetic analyses in an auditable manner consistent with GLP practices, where applicable;
Develop departmental procedures (SOP's, Protocols, Safety Procedures);
May train/mentor others.
DEMONSTRATE THE FOLLOWING SCIENTIFIC COMPETENCIES:
Serve as PKDM representative for projects, especially in the area of M
Can recommend a course of action to solve M
Can act as a resource to address technical and theoretical issues in the M
Be able to operate in a multicultural environment and participate in international teams;
Understand the general scientific basis of protocols and overall study objectives as related to assigned studies;
Participate in the preparation of protocols and/or analysis plans;
Prepare and issue preliminary notes, key results summaries, CSR sections, and stand-alone M
Summarize documents for submission to regulatory agencies, including but not limited to the FDA and EMA;
Can represent our company to regulatory agencies;
Participate and/or present at departmental, external and international meetings within the company;
Prepare abstracts, posters and manuscripts for presentation and/or publication;
Present at external scientific meetings as appropriate;
Identify skill-sets necessary to advance career development.
Ensure that all assigned project activities are performed in compliance with current departmental SOP's, guidelines, industry best practices and regulatory guidelines, and are conducted following acceptable scientific rationale:
Possess excellent interpersonal communications skills commensurate with working in a multicultural organization;
Demonstrate a proficiency at scheduling multiple activities;
Monitor compliance with any appropriate company guidelines;
Independently accountable for meeting project timelines.
Formal education and experience required:
Technical expertise in several of the following areas: population PK and PK/PD modeling, Clinical trial simulation, PK/PD modeling and simulation, PBPK modeling.
Ph.D. with or without post-doctoral experience in a biological, chemical, mathematical, computer science or closely related discipline plus at least 6 years of relevant experience;
Equivalent theoretical and technical knowledge.
Base Salary - $119,000 to $165,000
Benefits - Full
Relocation Assistance Available - Possible for ideal candidate
Bonus Eligible - Yes
Interview Travel Reimbursed - Yes
5+ to 7 years experience
Management Experience Required - Yes
Minimum Education - Doctorate Degree
Willingness to Travel - Occasionally
Job Category: Research & Development
Also, please understand this may take time for both of us working together to help advance your career. I will do my best for you and never charge you anything for our time and efforts.
In all cases we always have several jobs not yet published on the WWW, listed on linkedin or posted to our company website.
Many full job descriptions and base salaries in your field of experience can be viewed in various sections on -