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Director, Epidemiology and Research Strategy
2 months ago
We are seeking a highly skilled and experienced Director to lead our Epidemiology and Research Strategy team at 1925 GlaxoSmithKline LLC. As a key member of our organization, you will be responsible for driving the development and execution of our epidemiology strategy across the entire spectrum of drug development, from early drug discovery to registration and lifecycle management.
Key Responsibilities- Develop and Maintain Epidemiology Strategy: As a technical expert in epidemiology and the therapeutic area, you will develop and maintain an epidemiology strategy aligned to the drug development strategy.
- Improve Disease Understanding: You will improve disease understanding relevant to drug development, including 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 Real World Evidence Strategies: You will support and be accountable to advise scientifically on Real World Evidence strategies.
- Contribute to Medication Safety Evaluation: You will contribute to medication safety evaluation, providing background event rates, synthesizing existing evidence, including through meta-analyses, identifying high-risk populations.
- Propose and Lead Post-Marketing Activities: You will propose and lead post-marketing activities, including risk evaluation mitigation strategies, epidemiology studies for signal detection and inference, post-authorization studies of treatment benefit and risk.
- Critically Appraise Existing Epidemiology Evidence: You will critically appraise existing epidemiology evidence and create new evidence through delivery of specific research plans/protocols and analysis of healthcare databases available within GSK.
- Develop Strong Partnerships: You will 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: You will plan resource allocation to accomplish multiple research projects and attain project and study timelines.
- Identify Innovative Methods: You will identify innovative, timely, and cost-effective methods to conduct epidemiologic studies.
- Negotiate Internal Funding: You will negotiate internal funding of projects.
- Develop and Negotiate Research Plans: You will 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: You will communicate study findings to relevant internal and external audiences effectively.
- Input into Regulatory Submission Documents: You will input into regulatory submission documents and represent the function to regulatory agencies as required.
- Present Company Position: You will present the company position on epidemiology issues and epidemiology findings to regulatory agencies and other external authorities.
- Extend Track Record of Publications: You will extend a track record of external publications in peer-reviewed journals in support of asset teams.
- Strengthen Epidemiology Group Position: You will strengthen the position of the Epidemiology group as a recognized leader in the application of epidemiology to drug development.
We are looking for professionals with the following required skills to achieve our goals:
- A combination of academic training and practical experience in epidemiology is required. This may consist of:
- Doctoral degree (PhD., ScD or DrPH) in epidemiology or a relevant discipline (i.e. health services research, health outcomes research, public health, statistics or pharmaceutical sciences).
- Clinical degree (e.g., in medicine, pharmacy, nursing) and a masters degree in Epidemiology with 5+ years experience leading pharmaco-epidemiologic research in a drug development environment.
- Experience leading pharmaco-epidemiologic research programs in a drug development environment.
If you have the following characteristics, it would be a plus:
- Excellent oral and written communication skills and demonstrated ability to communicate scientific evidence to peers and at scientific meetings.
- Expertise in epidemiology of respiratory conditions.
- 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 organizational 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.
