ISIS Pharmaceuticals http://www.isispharm.com) is seeking a
highly motivated individual for the following position:
DIRECTOR, PHARMACOKINETICS & CLINICAL PHARMACOLOGY
This position will report directly to the Vice President (Pharmacokinetics and
Clinical Pharmacology). The primary responsibilities of this director-level
position will be to characterize and document the pharmacokinetic
(PK)/toxicokinetic (TK) properties of new chemical entities in development
(both preclinical and clinical) for various therapeutic areas (cardiovascular,
metabolic, oncology, etc.), as well as providing expert TK/PK support to the
toxicology and clinical groups at Isis (and our partners). Providing
supervision, assistance, and/or mentorship to analysis, report writing, and
model development conducted by other development PK and bioanalytical (BA)
scientists is expected. Evaluation of relationships between PK and
pharmacodynamic (PD) measures (using graphical techniques and modeling) for
compounds at various stages of development are another responsibility of this
position. Scientific oversight of selected external CROs providing PK and BA
support for Isis projects/studies is expected. This position conducts,
contributes to, or supervises the planning, writing, reviewing and summarizing
of preclinical and clinical PK and PK/PD assessments (study protocols,
analyses, reports and integrated summaries) for development projects and
ultimately for regulatory submissions (e.g., IND, IMPD, IB, annual report, CTD,
etc.). This position must work closely with the Project Team to ensure timely
and accurate communication of results and provide necessary support and
expertise to the development of new chemical entities. Contributions are also
expected for improving antisense as a core technology through collaborations
with exploratory research PK efforts and with academic laboratories (e.g.,
metabolism research, cellular uptake pathways, oral delivery, etc.).
Applicants must possess an excellent working knowledge of the fundamental
principles of PK and PK/PD analyses for both preclinical and clinical studies,
and a good publication record in the field. A working knowledge of GLP
requirements for bioanalytical and PK studies is also required.
This is an ideal position for someone who is motivated by the opportunity to
contribute (both in direct hands-on and supervisory roles) their skills to
pharmaceutical development from research to IND-enabling development and
through to the design and analyses of Phase 1-3 clinical studies. The
successful applicant will join an established team in the Pharmacokinetics &
Clinical Pharmacology group who are leaders in the field of antisense
development and are internationally recognized for their efforts.
Job Specifications:
* Ph.D. in Pharmacokinetics, Biopharmaceutics, or other related
pharmaceutical science
* 8+ years of experience in pharmaceutical or biotech industry
* Experience with multiple regulatory submissions and interactions
* Proven effective management skills
* Familiarity and direct experience with common software tools for PK
analysis (WinNonlin, NONMEM, SPLUS, etc.)
* Research experience with in vivo and in vitro metabolism studies, and
extensive knowledge of various bioanalytical methodologies and procedures,
would be a plus
* Excellent oral and written communication skills
* An ability to be productive and successful in an intense work
environment
Excellent Salary and Benefits Package Offered.
For more information on Isis and to apply for this position, please visit our
website, http://www.isispharm.com. Reference Requisition
#298