Job Title: Clinical Project Leader
Location: Winston-Salem, NC
Category: Research & Development
Company Information: R.J. Reynolds Tobacco Company (R.J. Reynolds) is the second-largest tobacco company in the United States, manufacturing about one of every three cigarettes sold in the country.
R.J. Reynolds is an indirect wholly owned subsidiary of Reynolds American Inc. (NYSE: RAI). Reynolds American (RAI) is also the parent company of Santa Fe Natural Tobacco Company, Inc., American Snuff Company, LCC and Niconovum AB.
Position Description: R.J. Reynolds Tobacco Company is seeking a qualified clinical project leader to conduct clinical studies with new and existing tobacco products in support of RJRT's vision of transforming tobacco and reducing tobacco-related health risks. The successful candidate will join our R&D clinical studies team in Winston-Salem, NC.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
The incumbent will be required to 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 interact with clinical studies team members, product development teams, and management on a routine basis 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 collaborate with external vendors and with other RJRT functions to ensure R&D project deliverables and timelines are met.
Key responsibilities will include:
1. Design human clinical studies and interpret resulting data to support product development, post-market surveillance, regulatory submissions and exploratory research.
2. Manage human clinical studies outsourced to contract research organizations, ensuring compliance with GCP requirements and applicable FDA regulations/ guidances.
3. Lead collaborative project study teams comprised of internal staff and external vendors.
4. Prepare and publish scientific results obtained from RJRT's human clinical studies in peer-reviewed scientific journals and present, as appropriate, at scientific meetings.
Position Qualification: REQUIREMENTS:
. Masters or Ph.D. in biology, chemistry, toxicology, pharmacy, public health or related discipline with a minimum of 5 years of work experience in clinical research or clinical trials.
. Fundamental understanding of basic biological and statistical concepts.
. Experience with FDA regulatory submissions preferred.
. Excellent project management, time management and team collaboration skills.
. Excellent interpersonal, written/oral communication and presentation skills.
. CCRC, CCRA or CCRP certification preferred.
OTHER PREFERED EXPERIENCE/DESIRED QUALIFICATIONS:
. Knowledge of abuse liability assessment, patient reported outcome measures, and/or experience with FDA regulated pharmaceuticals is beneficial.
. Ability to think both tactically and strategically.
. Ability to work and make decisions with minimal supervision.
Compensation: Competitive Annual Salary
Targeted Annual Bonus
Relocation assistance available for those who qualify.
Benefits Information: Our company offers very competitive compensation and benefit plans, including:
Generous annual bonus program for all employees
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
Education initiative plans
Federal credit union membership through Allegacy Federal Credit Union
Extensive training and opportunities for professional and career development
Company Statement: ABOUT OUR ORGANIZATION:
Reynolds American Inc. and its subsidiaries are Equal Opportunity / Affirmative Action employers.
Our organization offers a level of challenge, responsibility and creativity for motivated employees that stands apart from the crowd.
We are also committed to employing a diverse workforce and valuing different perspectives, experiences and talents to maximize the company''s potential for successfully achieving its business objectives.
Only applicants requiring reasonable accommodation for any part of the application and hiring process should contact us directly.
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