Job Description

BAT is evolving at pace - truly like no other organisation.

To achieve the ambition, we have set for ourselves, we are looking for colleagues who are ready to live our ethos every day. Come be a part of this journey!

BAT UK IS LOOKING FOR AN IN VITRO REGULATORY SCIENTIST

SENIORITY LEVEL: Mid-Level

FUNCTION: Scientific Research

SUB FUNCTION: Life Sciences

LOCATION: Southampton, UK

TYPE OF CONTRACT: Permanent

BENEFITS

• UK yearly Incentive Bonus - competitive % 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?

• Execute pre-clinical capabilities, inclusive of in silico, in vitro and in vivo models, for predominantly regulatory submissions, inclusive of but not limited to FDA authorisations and approvals
• The role will be accountable for executing the tools, knowledge, and data in preclinical sciences across all BAT categories.
• The primary purpose of preclinical data is to satisfy BATs duty of care by substantiating consumer product safety, meeting regulatory obligations and providing scientific substantiation of health-related claims such as reduced risk versus a cigarette or wellbeing and stimulations claims in the beyond nicotine strategy.
• The scientific programme must position BAT, and any associated acquisitions or investments, product portfolio as a trusted brand in safety and efficacy and must be recognised credibly externally.

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

• The pre-clinical screening and evaluation capabilities will be utilised in supporting BATs nicotine and tobacco and beyond tobacco product category strategy, in the first instance enabling launches and in the second instance identifying a competitive pipeline.
• Role directly delivers BAT\'s core purpose of A Better Tomorrow, via the science and technical framework proving the reduction in public health impact of our business

Reports to

Senior Scientist Pre-Clinical Regulatory

Number of Direct Reports

0

Core Relationships

Internal - Scientific Research, New Categories R&D, Procurement, US Submissions Teams

External - Regulators, 3rd Party suppliers

Geographic Scope

Global

Travel Required

Infrequent

WHAT YOU WILL BE ACCOUNTABLE FOR

• Execute and manage the delivery of the data packages to submit regulatory dossiers, such as the FDA pre-market approvals and modified risk claims
• Input into applying knowledge in a broad range of cell biology and in vitro toxicology methodologies, including knowledge of respiratory and / or cardiovascular diseases.
• Input in the delivery of high content screening approaches, data integration and analysis to support Pre-clinical and Toxicology Team assessments for regulatory purposes
• Work with commercial and legal partners in scrutinising and agreeing contracts with CROs and ongoing studies to ensure they are conducted according to protocol guidelines, agreed budget and timelines.
• Manage ongoing monitoring and delivery of pre-clinical studies On-Time-In-Full (OTIF) and managing project budgets.
• Input into engagement activities with key stakeholders and prepare and deliver presentations at internal and external meetings on behalf of BAT Scientific Research
• Identify requirements and approve procedures/processes to ensure \'Best Practice\' is followed e.g. HTA; GLP.
• Input in the development of pre-clinical assessment strategies to deliver transformational skills and cutting-edge capabilities for product assessment.
• Monitor the competitor landscape and coordinate the activities of preclinical researchers, statisticians, data analysts and other research team members involved in pre-clinical studies.
• Contribute to regulatory dossier preparations, internal and external communications, and publications.
• Complete tasks in accordance with BAT R&D business strategy and the code of business conduct.

ESSENTIAL EXPERIENCE, SKILLS, AND KNOWLEDGE

Experience Required

• Expertise in cell biology, molecular toxicology, or pharmacology with a relevant degree and preferably PhD in biological sciences.
• Proven ability in the application of innovative in-vitro approaches in the pre-clinical field to bridge to clinical endpoints and human health effects.
• Preferably, experience in disease pathways / mechanistic understanding / adverse outcome pathway-based approaches
• Demonstrable ability to apply bioinformatics tools to process and assess biological data.
• Demonstrable experience in, disease modelling, adverse outcome pathways, toxicology and / or pharmacology with the ability to set the strategy for the team - integrating and interpreting complex data to provide clear guidance and support for product launches and the evaluation of the competitor and safety landscape.
• Ability to apply knowledge in a broad range of novel in-vitro biology / toxicology methodologies to determine direction.
• Expertise in basic IT (Word/ Excel/ Power Point) and the application of bioinformatics, data analysis / computational tools.

Technical / Functional / Leadership Skills Required

• Project management of pre-clinical studies
• Study design and interpretation in a relevant field
• Proven skills at scientific communication to technical and non-technical, internal and external audiences

Education / Qualifications / Certifications Required

• Relevant degree in biological sciences

BENEFICIAL

• Experience in FDA submissions and engagement
• PHD in biological sciences

WE ARE BAT

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

BELONGING, ACHIEVING, TOGETHER

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!

British American Tobacco