Sr. Clinical Pharmacologist

Job Description

Job Description
* The position is responsible for efficient, innovative, and timely clinical PK, PK/PD, and/or population PK study design, analysis, interpretation, and reporting of clinical studies to support international regulatory submissions.
* Provide small and large molecule clinical pharmacology expertise/support in the preparation of regulatory submissions (e.g. IB, IND, NDA).

* Performs pharmacokinetic analysis, interpretation, and reporting of data from clinical studies
* Responsible for design, analysis and communication of data on clinical pharmacology studies
* Develops and implements new clinical pharmacology studies that impact development programs
* Effectively represents clinical pharmacology in cross-functional study-team settings
* Works in close partnership with Quantitative Pharmacology, Bioanalytical Chemistry, Project Management, Clinical Research, Biostatistics and Clinical Trials Management functional areas to support clinical development programs.
Conducts clinical pharmacology studies in line with clinical PK and product development strategies.
Designs and works with CRA regarding implementation and conduct of clinical pharmacology studies
Analyzes, interprets, and writes reports for clinical and regulatory submissions.
Ensures the quality of patient care and adherence to scientific, safety and regulatory standards.
Assists with managing timelines and budgets to insure prompt and accurate execution of clinical studies.
Analyzes moderately complex problems in component parts and to identify causal relations.
In-depth knowledge and understanding of pharmacokinetic regulatory requirements for US and EC are required.
Working knowledge of pharmacokinetic program and analysis software (such as WinNonlin, SAS etc.) along with PK modeling and computer skills in scientific graphing.

Education and Experience:
* 7+ years of experience and an MD, PhD or PharmD degree in pharmacokinetics or a related scientific discipline.
* Strong understanding of clinical pharmacokinetic concepts is required
* Training/experience in advanced pharmacokinetics, clinical pharmacology and/or pharmacy with clinical research, drug development is desirable
* Understanding of drug development process to provide clinical pharmacology support for clinical development (Phase 1 to Phase 4) for investigational agents and/or marketed drugs.

Assists in the implementation of the Phase I/II clinical development plans for complex product development strategies.
* Designs and works with CRA and CTM management regarding implementation and conduct of clinical pharmacology studies.
* Directs the activities and resources, for both internal and external contractors/vendors.
* Analyzes, interprets, and writes, reports for clinical and regulatory submissions.
* Hands-on experience in clinical trials management/study conduct and/or basic laboratory sciences is desirable
* Must have established computer skills with detailed knowledge of PK programs and analysis software (e.g. WinNonlin), along with experience with scientific graphing and analysis software (Sigma plot, GraphPad, Instat, etc). Must have excellent written and verbal communication skills.
* Must have excellent interpersonal, written and verbal communication skills
* Must have critical thinking skills and ability to make decisions
* Demonstrate ability to work independently
* Exhibit excellent written and verbal data presentation skills to enable contribution to internal/external teams, conference presentations and publications
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