Compass Life Sciences have exclusively partnered with a top 10 global pharma, to appoint a Director of Epidemiology as part of a global team. The position will sit within an exciting group that covers a spectrum across all therapy areas and stages of development, from Discovery through to lifecycle management.
This position can be either office based at one of our clients numerous locations, or be remotely based across Europe, the UK, or the US.
As part of the global Epidemiology group, and the wider R&D Value, Evidence, and Outcomes function, the Director of Epidemiology contributes to the successful development and commercialisation of new therapies, whilst supporting Clinical Development, Safety, and Effectiveness Evaluation across the business. This role also has responsibility for contributing to the design and implementation of value evidence projects to support product differentiation as part of the holistic real world evidence strategy.
You will have epidemiology responsibility for multiple development compounds and marketed medicines within a therapeutic area, to develop a program of real world evidence studies. Using your background within epidemiology, you will be responsible for planning, implementing and delivering high quality, scientifically robust observational research projects which support drug development programs, regulatory submissions, payer discussions and post marketing safety and effectiveness.
Key responsibilities within this role will include;
- As a technical expert in epidemiology and the therapeutic area, maintain and expand an epidemiology and value evidence support strategy aligned to the drug development strategy.
- Improve disease understanding relevant to drug development: incidence, prevalence, risk factors, natural history course, treatment patterns, co-morbidities, co-medications, outcome measures, phenotypes, biomarkers, unmet needs, and their variations across domains such as demographics and geographies.
- Support and be accountable to advise scientifically on Real World Evidence strategies
- Contribute to medication safety evaluation: provide background event rates, synthesize existing evidence including through meta-analyses, identify high-risk populations.
- Propose and lead post-marketing activities: risk evaluation mitigation strategies, epidemiology studies for signal detection and inference, post-authorization studies of treatment benefit and risk.
- Contribute to value evidence strategy developing studies to support product differentiation.
- Lead discussions with regulators and payers related to the real world evidence program.
- Critically appraise existing real world evidence and create new evidence through delivery of specific research plans/protocols and analysis of healthcare databases available within GSK.
- Develop strong partnerships with internal stakeholders in a multi-disciplinary framework (clinical, safety, regulatory, health outcomes, asset leadership) to meet product needs.
- Plan resource allocation to accomplish multiple research projects and attain project and study timelines.
- Identify innovative, timely and cost effective methods to conduct epidemiologic and value evidence studies.
- Negotiate internal funding of projects.
- Develop and negotiate research plans with external collaborators in academia or contract research organizations and work effectively with vendors for outsourced studies.
- Communicate study findings to relevant internal and external audiences effectively.
- Input into regulatory and payer submission documents and represent the function to regulatory agencies and payers as required
- Present the company position on epidemiology issues and epidemiology findings to regulatory agencies and other external authorities (e.g. payers).
- Extend a track record of external publications in peer reviewed journals in support of asset teams.
To be considered for this role, our client is looking for seasoned experts within the field of Epidemiology. You need to be able to demonstrate either a PhD. or MSc. within a relevant epidemiological subject, coupled with significant experience leading pharmacoepidemiologic research in drug development. In addition to this, our client is looking for candidates who can demonstrate experience communicating scientific evidence to peers and at scientific meetings.
Ideally you should also be able to demonstrate some of the following desirable experiences;
- Expertise in epidemiology of chronic conditions, preferably renal and metabolic conditions
- Experience of interactions with regulatory and payer authorities
- Self motivated with the ability to work independently to develop credibility with colleagues within and outside Epidemiology, as well as interact effectively in multi-disciplinary matrix teams to influence decisions.
- Broad experience in collaborating with research partners
- Ability to demonstrate strategic thinking and problem resolution to fill evidence gaps.
- Ability to work well within a business-driven environment, balance priorities and handle multiple tasks through careful planning, stakeholder management, project administration, and organisational skills.
- Record of high-quality, peer-reviewed epidemiology and/or outcomes research publications and/or demonstrated leadership in external scientific societies/industry-wide collaboration
- Experience in leading epidemiology research in US and EU
In return, our client is offering an industry leading package which you'd expect from a top tier pharmaceutical company. To apply or for further information please contact Gareth Hughes-Jones, Head of Data, at [email protected], or call +44 (0)2392 311 034. Compass Life Sciences is a trading name of Compass Associates Ltd, and are acting as a Recruitment Consultancy for this permanent vacancy.