PPD Assoc Clinical Scientist- Oncology in India, Indiana
Provides support in clinical and scientific consultation across therapeutic areas, in partnership with senior
scientists. Provides input into, and coordinates, input for clinical consulting RFPs, supporting the clinical
trial RFP process and partnering with feasibility and study operations through medical and data analysis
to summarize the epidemiology, standard of care, and competitive environment for the given opportunity.
Develops, designs and optimizes protocol synopses and full protocols.
Creates clinical development plans and gap analyses.
Assists in coordination of key opinion leader advisory boards.
Conducts feasibility assessments.
Provides competitive intelligence support for the RFP process.
Provides clinical strategy into pre-IND briefing packages.
Provides IND and NDA/BLA submission support.
Performs other global regulatory submissions as needed.
Education and Experience:
Pharm D. or Ph.D. in a scientific discipline or related field required.
2 years of experience working in the biotech/pharmaceutical industry
In some cases an equivalency, consisting of a combination of appropriate education, training
and/or directly related experience, will be considered sufficient for an individual to meet the
requirements of the role.
Knowledge, Skills and Abilities:
Familiarity with the conduct of global clinical trials
Basic knowledge of GCP/IHC and FDA guidelines
Good interpersonal and communication skills
Good attention to detail
Good organizational, prioritization and time management skills
Capable of working on multiple projects simultaneously
General familiarity with biostatistics and pharmacokinetics
Proficient in navigating scientific literature, interpretation of data & display of data
Capable of working both independently and in a team environment
Highly proficient in standard computer software (MS Word, Excel, Power Point)
Strong team work skills required to work with a cross-functional consulting team (experts in
regulatory strategy, product development, biostatistics and pharmacokinetics)
Job: *Global Product Development
Organization: *IN BU
Title: Assoc Clinical Scientist- Oncology
Requisition ID: 192376
PPD is an affirmative action employer that values diversity as a strength fosters and environment of mutual respect. PPD provides equal employment opportunities without regard to age, race, color, pregnancy, national origin, religion, sex, gender identity, sexual orientation, disability, veteran status or other status within any other protected group
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