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Director/Sr Director of Clinical Pharmacology

Posted on Aug 27, 2020 by Kura Oncology Inc

San Diego, CA
Health Care
Immediate Start
Annual Salary
Full-Time

ESSENTIAL_JOB_FUNCTIONS:

The Director/Senior Director of Clinical Pharmacology will be responsible for
developing, driving, and implementing nonclinical and clinical ADME strategies.
You will be a core member of program teams providing ADME perspectives and
delivering modeling and analyses necessary to evaluate nonclinical and clinical
options, enable plans, and optimize development programs. This includes gap
analysis, study design, PKPD analysis and modeling, program assessment, and
collaborations to help execute programs. The successful candidate will bring
extensive experience in nonclinical and clinical ADME with the ability to work
cross-functionally with multifunctional teams to drive programs to success.

JOB_SPECIFICATIONS:
* Provides clinical pharmacology leadership on multi-disciplinary teams for
oncology programs including in vitro and in vivo ADME assessment of lead
compounds to satisfy world-wide regulatory requirements
* Provides pharmacokinetic expertise at a project level (including non-
clinical and clinical development plans) which includes design,
implementation and completion of nonclinical ADME studies as well as
pharmacokinetic study design for clinical trials.
* Develop exposure-response and mechanistic PK/PD models to evaluate risk/
benefit and facilitate drug development decisions.
* Experience in developing appropriate nonclinical and clinical drug
interaction studies and various strategies to address ADME challenges
* Accountable for ensuring appropriate design and implementation of PK/PD
modeling and simulation plans and interpretation of results.
* Provides clinical pharmacology support and leadership in preparation of
various regulatory interactions including Investigator s Brochure,
Clinical Pharmacology section of INDs, CTAs BLAs and/or NDAs, regulatory
queries and clinical pharmacology section of package inserts

QUALIFICATIONS:
* 10+ years of experience in drug metabolism and pharmacokinetics within a
large pharma and / or biotech companies
* Experience with nonclinical and clinical pharmacokinetic protocol design
with experience working with CRO s is required.
* An in-depth understanding of all aspects of ADME with special emphasis on
the application of pharmacokinetics in drug development and clinical
pharmacology study design with the ability to work in a team-based drug
development environment is required.
* Thorough knowledge of drug development of NCEs, including ADME studies
with sufficient depth to aid in selection of drug candidates, as well as
interpretation and implications of results for the project.
* Knowledge and experience with the design of experiments to define PK-PD
relationships and competency using non-compartmental techniques,
population pharmacokinetics and pharmacokinetic modeling software
* Provide interpretation of clinical pharmacology data and incorporate
appropriate analyses into reports suitable for regulatory submissions

EDUCATION
Ph.D. Pharmacokinetics or a closely related discipline or PharmD preferred

PHYSICAL_DEMANDS:

While performing the duties the employee is:
1. constantly required to sit, and to reach to use computers and other
office equipment
2. occasionally stand for extended periods of time, up to four (4) hours/
time.
3. occasionally required to lift up to 10 pounds
4. constantly required to view objects at close and distant ranges
5. frequently required to communicate with others
Note: For the purpose of this summary, occasionally is used to represent up to
1/3 of the time given to the work day, frequently represents 1/3 to 2/3 of the
time and constantly represents 2/3 or more of the time.

WORK_ENVIRONMENT:

Employee frequently works in a professional office environment and lab with
lots of computer equipment, tools, and moderate amounts of noise and
activity. Employee may occasionally be required to travel. The work environmen
is fast-paced and demanding. Off-shift, weekend and overtime duties may be
required as assigned by the manager.
Kura Oncology offers an attractive salary and benefits package, including
equity incentives. To apply, please submit your resume
to
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Reference: 27238657

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