Title
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 our
aggressive and innovative oligonucleotide drug development pipeline. The
successful candidate will be supporting preclinical and clinical drug
development by providing DMPK, clinical pharmacology and PK/PD expertise across
early and late development phases. A strong background and hands on experience
in PK/PD modeling and simulation is highly desirable. The candidate will
represent the PK/CP Department in cross-functional teams and influence study
designs, execution and analysis of DMPK and clinical pharmacology studies. In
addition, he/she will support project teams with modeling-and-simulation-based
input to clinical trial design, evaluations and integrated data analysis and
reporting.
Major Responsibilities:
1. Design clinical pharmacology strategy for assigned program and
coordinate pharmacokinetic/DMPK related elements for preclinical and/or
clinical projects. In addition, identify potential project hurdles, suggest
solutions, and establish contingency plans.
2. Perform PK/PD analyses using a variety of methodologies and software
tools. Integrate, interpret and report data to project teams, business partners
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 regulatory
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 guidance from
the manager.
4. Monitor timelines, objectives and budgets as appropriate. In addition,
assure rapid and effective communication of high-quality data and results to
project teams.
5. Lead or participate in PK/CP or project sub-teams and coordinate with
appropriate sub-team members and/or prepare summary documentation.
6. Occasionally, support early research in experimental pharmacokinetics.
Minimum Qualifications:
Ph.D. in a relevant discipline, Pharm D. with appropriate post-doctoral
training 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 of
cross functional teams in a highly dynamic, matrix and project-team environment
5. Excellent oral and written communication skills
6. Strong organizational and project skills
7. Excellent critical thinking and problem solving skills, including
publications/presentations
8. Strong influencing and negotiating skills
9. Coaching, mentoring, and people management skills
Please respond with CV and also apply at
http://www.isispharm.com.
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:
[email protected]<mailto:[email protected]>
About Isis Pharmaceuticals:
Isis Pharmaceuticals, Inc., located in the North San Diego County city of
Carlsbad, was founded in 1989 to create advanced, novel medicines to treat
complex and challenging diseases. We are the pioneer in the discovery and
development of antisense drugs with more than 1200 patents. Isis is a
challenging, motivating and rewarding environment designed to foster innovation
and 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 into this
creative environment to be part of a productive team. Join us and experience
our unique culture while you develop and expand your career.
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