US-Colorado-Westminster: Senior Clinical Research Scientist
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Date: 01-Jul-2008

Senior Clinical Research Scientist

Specific Responsibilities: Requires knowledge of pharmacokinetics, in
vitro and in vivo drug metabolism. Training and experience in
pharmacokinetic/pharmacodynamic modeling and simulation using
WinNonlin, NONMEM or other relevant software is highly desirable.
Knowledge of bioanalysis using HPLC-MS/MS is a plus.

This position is responsible for all aspects of clinical science
including research, developing and writing study protocol, study
summaries and clinical study reports working in close association
witha cross functional clinical, biometrics and regulatory team.

This position will be responsible for contributing to study design and
implementation of study designs across phase 1 through phase 4
studies, with special emphasis on clinical pharmacology.

Essential Duties and Job Functions: Interfaces with staff to share
scientific and clinical information and consistent practices. Leads
protocol review discussions concerning scientific and procedural
aspects of study design. Serves as resource for junior staff. Oversees
the scientific aspects of clinical studies throughout duration of
study. Prepares study protocols, amendments, specific sections of
study manuals and Investigator meeting notebooks, and other documents
as needed. Supervises or assists other CRS staff with preparation of
above. Contributes to the design and development of CRFs, Data
Management Manuals and Data Analysis Plans. Helps insure consistency
across protocols. Presents scientific information if needed. Addresses
questions regarding scientific and related procedural issues from
Investigators. Coordinates and implements ongoing data for internal
analysis and review. Coordinates the preparation and/or review of data
listings, summary tables, study results, scientific presentations, and
manuscripts for publication. Coordinates the preparation/review of
regulatory documents, IND annual reports, IND safety reports,
Investigator Brochures and NDAs. Determines the functions most
critical to company success and supports priorities within functional
area. Anticipates fairly complex obstacles and client difficulties and
implements solutions that meet goals. Creates effective teams with a
clear sense of direction. May lead two or more specific components of
departmental strategic initiatives.

Knowledge, Experience and Skills: Excellent verbal and written
communication skills and interpersonal skills are required to maintain
working relationship with team members to ensure scientific integrity
of clinical studies. Is sought out for advice by others within the
company to help make better decisions and resolve problems. Examines
functional issues from a broader organization perspective. Must be
able to design and use all available vehicles for effective scientific
communication within the company. Good working knowledge of cardiology
and/or pulmonology, treatment, and clinical management along with a
good general working knowledge of infectious diseases. Knowledge of
clinical trial design to develop specific study concept sheets and
protocols is required.

Typically requires a BS degree in Biological Sciences, health care or
related field and minimum 11 years of relevant experience or a MS
degree and minimum 9 years of relevant experience. Typically a higher
degree Pharm.D or Ph.D. in clinical research or clinical pharmacology
and experience in a pharmaceutical company or contract research
organization along with knowledge of clinical trial design and
experience with protocol/report writing is preferred.

Thank you,
BioTech FYI Center
http://biotech.fyicenter.com/