Senior Scientist, Clinical Pharmacology
South San Francisco, CA 
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Job Description

The Position

The Clinical Pharmacology Scientist is responsible for the Clinical Pharmacology (CP)

strategy for his/her development project[s] in order to ensure that appropriate

dose/route/schedule decisions are made for the patients. The CP Scientist uses state of the

art model-informed drug development strategies that are aligned with project needs. The CP

Scientist works in close partnership with Pharmacometricians, Biostatisticians, Clinicians and

cross-functional project teams. Responsibilities include; leading the design & review of CP

study protocols and analysis plans where appropriate, contributing to the design and review

of clinical protocols and analysis plans, analysis and interpretation of PK/PD data,

preparation and review of clinical study reports, presentation of PK/PD data at cross-functional teams, department meetings, conferences and regulatory meetings as well as

planning, implementation and organization of regulatory filings (eg. IND, End-of Phase 2

meeting, EU Scientific Advice meeting, BLA, NDA, sNDA). Performs other duties as

assigned.

Technical Skills:

Familiarity with quantitative approaches in drug development, working knowledge of relevant

modeling software (eg. NONMEM, ADAPTII, WinNonlin, Berkeley Madonna, R, S-Plus,

SimCYP, GastroPlus) and the ability to plan, organize, and critically assess and/or perform

PK/PD data analyses. Familiarity with clinical study design options, especially for phase 1

and 2 studies. Working knowledge of statistical approaches as they apply to clinical study

design & analysis. Working knowledge of relevant disease areas.

Communication Skills:

The CP Scientist requires excellent communication skills, both written and oral, in order to

deliver high quality protocols, regulatory documents, documents for team and management review, scientific manuscripts & posters for publication.

Drug Development Knowledge:

The CP Scientist requires relevant experience/knowledge of how CP science can impact

drug development. CP Scientist should have a good knowledge of GCP and working

knowledge of relevant regulatory guidelines.

Leadership:

Based on experience and ability, the CP Scientist may lead CP teams, project sub-teams

and represent CP at cross-functional project teams. Based on experience and ability, the CP

Scientist may manage other Scientists or Research Associates within CP department.

Qualifications:

  • MD, PhD, PharmD or equivalent
  • Multiple levels based on relevant experience in Pharmacokinetics, Pharmaceutical Sciences, Biomedical Engineering or related quantitative discipline.
    • Associate Scientist 0-3 years of experience
    • Scientist 3-5 years of experience
    • Senior Scientist 6-8 years of experience

#DEVSCI

#CLINPHARM

#LI-KM2


Roche is an Equal Opportunity Employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status.

 

Job Summary
Company
Start Date
As soon as possible
Employment Term and Type
Regular, Full Time
Required Education
Doctorate
Required Experience
0 to 3 years
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