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[NMusers] PK/PD Scientist/Consultant Position at Isis Pharmaceuticals, Inc.

From: Ken Luu <>
Date: Thu, 22 Jan 2015 01:53:20 +0000


PK/PD Scientist/Consultant (Eq. to Associate Director or Director Level)

Employment Type

Temporary (Part time to Full Time)

Job Description

The Pharmacokinetics & Clinical Pharmacology (PK/CP) Department is seeking =
a highly motivated pharmacokineticist/clinical pharmacologist to support ou=
r aggressive and innovative oligonucleotide drug development pipeline. The=
 successful candidate will be supporting preclinical and clinical drug deve=
lopment by providing DMPK, clinical pharmacology and PK/PD expertise across=
 early and late development phases. A strong background and hands on experi=
ence in PK/PD modeling and simulation is highly desirable. The candidate wi=
ll represent the PK/CP Department in cross-functional teams and influence s=
tudy designs, execution and analysis of DMPK and clinical pharmacology stud=
ies. In addition, he/she will support project teams with modeling-and-simul=
ation-based input to clinical trial design, evaluations and integrated data=
 analysis and reporting.

Major Responsibilities:
1. Design clinical pharmacology strategy for assigned program and coo=
rdinate pharmacokinetic/DMPK related elements for preclinical and/or clinic=
al projects. In addition, identify potential project hurdles, suggest solut=
ions, and establish contingency plans.
2. Perform PK/PD analyses using a variety of methodologies and softwa=
re tools. Integrate, interpret and report data to project teams, business p=
artners or partner lines. Create, advocate and implement innovative program=
 strategies. Lead the established PK/PD strategy and coordinate activities =
across projects.

3. Contribute expert input into key pre-clinical, clinical and regula=
tory documents including clinical study protocols, clinical study reports, =
PK/PD modeling reports, investigator brochures, IND/IMPD's and NDA's within=
 agreed timelines and meeting all regulatory requirements under minimal gui=
dance from the manager.
4. Monitor timelines, objectives and budgets as appropriate. In addit=
ion, assure rapid and effective communication of high-quality data and resu=
lts to project teams.
5. Lead or participate in PK/CP or project sub-teams and coordinate w=
ith appropriate sub-team members and/or prepare summary documentation.
6. Occasionally, support early research in experimental pharmacokinet=

Minimum Qualifications:

Ph.D. in a relevant discipline, Pharm D. with appropriate post-doctoral tra=
ining or equivalent experience
1. At least 6-10 years of relevant postdoctoral, academic, industry, =
or government experience
2. Expert knowledge of PK/pharmacometrics tools (e.g., WinNonlin, SAS=
, NONMEM, R, S-Plus, Trial Simulator, GastroPlus and SymCyp, etc.)
3. Expert knowledge of related disciplines (e.g., DMPK, biostatistics=
, toxicology and regulatory) in the drug development process
4. Demonstrated experience and ability to work successfully as part o=
f cross functional teams in a highly dynamic, matrix and project-team envir=
5. Excellent oral and written communication skills
6. Strong organizational and project skills
7. Excellent critical thinking and problem solving skills, including =
8. Strong influencing and negotiating skills
9. Coaching, mentoring, and people management skills

Please respond with CV and also apply at<http://www.isisp=>.

Kenneth T. Luu, Ph.D.
Director | PK & Clinical Pharmacology
Isis Pharmaceuticals, Inc. | 2855 Gazelle Ct Carlsbad, CA 92010
Office: 760.603.2457 | Fax: 760-603-2502 | Email:<mailto:kl=>

About Isis Pharmaceuticals:
Isis Pharmaceuticals, Inc., located in the North San Diego County city of C=
arlsbad, was founded in 1989 to create advanced, novel medicines to treat c=
omplex and challenging diseases. We are the pioneer in the discovery and de=
velopment of antisense drugs with more than 1200 patents. Isis is a challe=
nging, motivating and rewarding environment designed to foster innovation a=
nd scientific excellence. Our founding goals have changed little in over 20=
 years and our success is a direct result of our outstanding employees. We =
are interested in bringing together individuals with different skill sets i=
nto this creative environment to be part of a productive team. Join us and =
experience our unique culture while you develop and expand your career.


Received on Wed Jan 21 2015 - 20:53:20 EST

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