Job Description

Clinical Research Manager  

Location: Flexible 

About Us 

 

We're a truly international company, fourth largest in our industry and operating across 119 markets. An inclusive, innovative global FMCG business supported by 26,000 employees. As we embrace a new era of growth, we are transforming. Our ways of working and culture are driven by a challenger mindset, constantly questioning the status quo where people can bring their best selves to work. Our agility and collaboration are driving our ambitions, innovation and success all supported by our award-winning development programmes that creates exciting and rewarding career opportunities for all.

As we move forward, our consumers will be at the heart of what we do, evolving to needs and expectations and committing to a more meaningful contribution to harm reduction by building a successful NGP business. Integral to our long-term success is our sustainability strategy, behaving responsibly and supporting our ambitions, all underpinned by high governance.

Encouraging inclusion at local levels and supporting a developing and robust diversity agenda globally, we’re fully committed to creating and maintaining an environment that celebrates and respects difference.

The Role

As the Clinical Research Manager (Team Scientific Substantiation & Engagement / Harm Reduction & Engagement) in the Global Science & Regulatory Affairs Team you lead and manage the global clinical research program that demonstrates the harm reduction potential across the portfolio of Imperial Brands’ Next Generation Products and supports our products in regulatory submissions.

Principal Accountabilities

• Leading the Clinical Science function in the Global Science & Regulatory Affairs team including the following activities:
• Proposing and managing the clinical research program & related studies to support our Next Generation Products (E-Cigarettes, Heated Tobacco, Oral Nicotine Products) as potentially less harmful alternatives for adult smokers with no interest or intention to quit and who would otherwise continue to smoke.
• Proposing and managing the clinical research program to support, protect and defend our products by providing evidence for submissions to regulators.
• Developing and managing timelines and budgets for clinical studies, ensuring a pro-active approach to scope management.
• Providing direction and leadership on single and multi-site global clinical studies in close collaboration with internal and external project teams to deliver the operational elements of the study plans from planning to executing.
• Delivering clinical studies to regulatory authority standards, company SOPs and internationally recognised quality standards e.g. ICH/GCP.
• Leading and managing activities related to the outsourcing of clinical studies to CROs and vendors ensuring delivery against contracted scope of work within budget remits including negotiation and contracts.
• Providing input and expertise to developing study documents including Clinical Study Protocols, Statements of Work, Requests for Proposals, Informed Consent Forms, Statistical Analysis Plans (SAP), Case Report Forms, laboratory and analytical documentations and other Clinical Science related documents like Auditing and Monitoring Plans, Risk Management Plans, Protocol Deviation Plans and Quality plans. Good understanding of clinical science statistics.
• Contributing to writing publication manuscripts and reviewing and updating of SOPs related to Clinical Science.
• Managing registration and publication of clinical study results on ClinicalTrials.gov and driving the publication process of results in peer-reviewed journals.
• Leading and supporting key study meetings with internal stakeholders, suppliers and vendors including kick off, investigator meetings, site initiation visits and lessons learned and contributing to monitoring activities and quality audits.
• Growing relationships with strategic external partners based on mutual trust, participating in regular update meetings and discussions regarding research projects and scientific developments with external experts.
• Engage with industry groups, relevant associations, external experts, consultants, and regulators to inform, validate and further develop our clinical research approach.
• Protect present and future business by providing to Corporate Affairs and Innovations with in-depth research support, specialist guidance, and advocacy on relevant challenges including critical analysis of scientific publications on current product regulatory questions.
• Engage with the scientific, public health, and regulatory communities through face-to-face meetings, regulatory filings, publications in scientific literature and participation in scientific conferences where we present our research.

Key Skills, Education & Experience

Essential

• Life science degree (PhD desirable) or equivalent plus relevant experience in an aspect of science related to clinical trial or medical biochemistry
• Strong and proven leadership skills driving high performing functions
• Substantial clinical research experience, with at least 2 years’ experience managing global clinical studies in phase 1 commercial clinical research units including planning, execution and reporting of studies.
• In-depth understanding of tobacco and related products and their regulatory challenges
• Strong understanding of the clinical development process with emphasis on early clinical studies with excellent knowledge of wider clinical research, ICH/GCP, clinical trial documents, design and regulatory processes.
• Excellent understanding of clinical research regulation and interpretation of those into clinical research.
• Excellence in performing literature assessments & reviews and familiar with QMS document storage systems.
• START WITH THE CONSUMER: Experience in clinical research for consumer claims (e.g. cosmetics & wellbeing) would be an appreciated added value.
• COLLABORATE WITH PURPOSE: Strong interpersonal skills along with an ability to build and leverage strong and meaningful working relationships internally and externally. Strong collaboration and project management experience in coordinating internal stakeholders and managing external execution partners suppliers to support Clinical Science research projects.
• TAKE ACCOUNTABILITY WITH CONFIDENCE: Strong organisational and prioritisation skills for the management of multiple concurrent projects and interdepartmental needs. Creative thinking and intellectual curiosity paired with a strong ability to understand complex relationships and communicate these easily across cultures and organisational levels tailored to different audiences including non-scientists.
• BE AUTHENTIC, INCLUSIVE TO ALL: Great communication ability at all levels within and outside the business, including presentation, written, oral and communication skills.
• BUILD OUR FUTURE: Curious in exploring new ways of working and proactive in proposing creative solutions and ideas.

Desirable

• Experience in working with the tobacco industry in a related clinical research field
• Strong partner networks in the clinical research industry including CRO, vendors and labs
• Experience in engaging externally with influential expert scientists

What We Offer

Competitive salary, bonus scheme, pension, and 25 days holiday (with an additional 4 days on top to cover the Christmas period, and bank holidays), flexible working policy, corporate discounts, Health Cash Plan, and other wellbeing initiatives.

Next Steps

Interested applicants are encouraged to apply, highlighting their suitability to the above post.