Scientist I: Clinical Project Leader

The Scientist I: Clinical Project Leader will collaborate with the Clinical Studies team, other members of Scientific & Regulatory Affairs, Product Development teams, and senior management across the enterprise regarding the project management of clinical studies and deliver on timelines. Co-Lead, manage and/or complete multiple clinical projects simultaneously. Actively partner across functional areas within the enterprise and with external vendors to ensure project deliverables and timelines are met.

What is the direct impact of this role on the team or organization?

This role is part of the Global Life Science's Clinical and Behavioral Sciences sub-function. The role of Global Life Science is to lead and drive the science program for BAT and to provide scientific evidence for BAT's products in support of tobacco harm reduction initiatives and regulatory priorities. The Clinical Studies team supports the Global Life Science objectives by leading and overseeing the design, initiation, execution, and reporting of global clinical studies.

Reports to,

• Function as a Clinical Project Leader (CPL) to coordinate the day-to-day execution of clinical studies outsourced to contract research organizations and provide support in management of a program of related studies, as needed.


• Co-lead and/or work collaboratively with project study teams comprised of internal staff and external vendors.


• Ensure that clinical or other relevant human research studies are designed and conducted in compliance with Good Clinical Practices (GCP) requirements, applicable regulations/guidance, and company Standard Operating Procedures.


• Handle timelines and budget for individual clinical studies.


• Contribute to or assist with the study design and interpretation of resulting data to support product development, regulatory submissions, and exploratory research.


• Contribute to the preparation and publication of scientific results obtained from enterprise-sponsored clinical studies in peer-reviewed scientific journals and present, as appropriate, at scientific meetings.


• Support related analytical analyses for clinical studies as needed.
  
  Do you have experience of clinical studies project management?


• Are you aware of ICH GCP and its meaning?


• Do you have experience of handling external vendors?


ESSENTIAL EXPERIENCE, SKILLS, AND KNOWLEDGE

Experience Required

• Previous work experience in scientific research, preferably with direct experience in conduct, management and/or assistance with regulatory oversight for clinical studies and experience in publication and presentation of scientific data.


Technical / Functional / Leadership Skills Required

• Ability to drive cross-functional collaborative efforts with multiple collaborators, internal clinical research partners and outsourced vendors.


• Capacity to work and make decisions with minimal supervision.


• Excellent time management and team collaboration skills.


• Excellent oral and written communication skills.


• Proficiency and ability to apply and document quality and regulatory practices / procedures supporting research studies.


• Ability to creatively contribute to key strategies at the department/division/enterprise level.


• Proficient in Word, Excel, and PowerPoint.


Education / Qualifications / Certifications Required

• PhD, Master's, or Bachelor's degree required in biology, chemistry, clinical science, pharmacy, public health, toxicology, or a related field.


BENEFICIAL

• Experience with regulatory submissions.


• Clinical Research Professional certification and/or membership of a relevant professional society.
  
  At BAT we are committed to our Purpose of creating A Better Tomorrow. This is what drives our people and our passion for innovation. See what is possible for you at BAT.


• Global Top Employer with 53,000 BAT people across more than 180 markets


• Brands sold in over 200 markets, made in 44 factories in 42 countries


• Newly established Tech Hubs building world-class capabilities for innovation in 4 strategic locations


• Diversity leader in the Financial Times and International Women's Day Best Practice winner


• Seal Award winner - one of 50 most sustainable companies, Collaboration, diversity and teamwork underpin everything we do here at BAT. We know that collaborating with colleagues from different backgrounds is what makes us stronger and best prepared to meet our business goals. Come bring your difference!
  
  UK yearly Incentive Bonus - driven % based on business results and average annual salary


• Attractive Private Pension Plan - up to 15%, Private Medical cover, Doctor @hand-24/7 GP appointments, by video or by phone, 365 days a year, from anywhere in the world


• Share Reward Scheme (free shares and share saving scheme), Group Personal Accident Insurance, Life Assurance


• Flexible Benefits Scheme: Tax Return Assistance, Cycle To Work, Holiday Trading, Dental Insurance, Travel Insurance; Onsite Gym and Gyms Discounts-discounts at over 3,700 gyms, SPAs, pools, studios and outdoor fitness events across the UK; Season Ticket loans-Interest free loans for purchase of annual tickets for public transport


What are the key objectives and expectations from this role?