The Master Scientist - Clinical Project Leader will design and lead human clinical studies to assess the use of tobacco products by adult smokers, smokeless tobacco users and/or users of electronic cigarettes. The incumbent will actively collaborate with clinical studies team members, product development teams, and senior management regarding the design of clinical studies and data interpretation. The individual must be able to manage and/or execute multiple projects simultaneously. The incumbent will actively partner across functional areas within RJRT and with external vendors to ensure R&D project deliverables and timelines are met.
Principal Duties & Responsibilities include:
Design - Design human clinical studies and interpret resulting data to support regulatory submissions, post-market surveillance efforts, product development research and exploratory biomarker development research.
Manage - Manage human clinical studies that are fully outsourced to contract research organizations, ensuring compliance with Sponsor SOPs, GCP requirements and applicable FDA regulations/guidances.
Lead - Lead collaborative project study teams comprised of internal staff and external vendors.
Publish - Prepare and publish scientific results obtained from completed clinical studies in peer-reviewed scientific journals and present, as appropriate, at scientific meetings.
Required Knowledge and Experience:
Masters required in biology, chemistry, toxicology, pharmacy, public health or related discipline.
7-10 years of work experience in clinical research, with a minimum of 4 years managing clinical trials.
PH.d is strongly prefered in biology, chemistry, toxicology, pharmacy, public health or related discipline.
Experience with FDA regulatory submissions
CCRC, CCRA or CCRP certification.
The Ideal Candidate will possess:
Ability to drive collaborative efforts cross-functionally and externally with outsourced vendors.
Ability to work and make decisions with minimal supervision.
Ability to develop and drive key strategies at the department level.
Excellent project management, time management and team collaboration skills.
Demonstrates effective oral and written communication skills.
Demonstrates interpersonal skills of dependability, reliability, and credibility.
Competitive Annual Salary
Targeted Annual Bonus
Relocation assistance available for those who qualify.
Our company offers very competitive compensation and benefit plans, including:
401(k) plan that offers opportunity to save on pre- and post-tax basis up to 50 percent of eligible compensation. Company matches 100 percent of employee pre-tax/Roth (401k) contributions up to six percent
Comprehensive health- and welfare-benefits package
Eleven paid company holidays annually, plus a generous paid vacation plan based on length of service
Company-paid sick and personal days, funeral leave and jury duty leave
A free, confidential personal financial counseling service
Free on-site health clinics and fitness centers
A matching grants program that enables employees to direct and double their donations to qualifying charitable organizations of their choice
A free health-care advocacy service
Volunteer service opportunities
Extensive training opportunities
RJ Reynolds - 5 months ago
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