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Epidemiology Scientist Director

New York, NY, USA | Eclaro

  • Industry:
    HR / Recruitment Services
  • Position Type:
    Full-Time
  • Functions:
    General Management
    Biotech/R&D/Science
  • Experience:
    5-7 years
Job Description:
90 people have viewed this job

Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for an Epidemiology Scientist Director for our client in New York, NY.  

Eclaro’s client is among the world’s largest pharmaceutical companies, trusted by billions to provide superior, cutting-edge, and inexpensive medicine that improves health and well-being. If you’re up to the challenge, then take a chance at this rewarding opportunity!

Position Overview:

The Epidemiology Scientist will partner with internal and external stakeholders on the design and conduct of epidemiologic research for regulatory submissions to the FDA, EMA and other agencies globally.

Propose and carry out various components of GME deliverables for development and product/asset teams, including:

Epidemiology RWD/RWE Research Strategy and Regulatory Effectiveness RWE Plans

Epidemiology background literature sections and supplemental RWD analyses for the Risk Management Plan (RMP) and Paediatric Investigation Plans (PIPs)

Epidemiology sections for other regulatory documents (e.g., ad-hoc regulatory requests, briefing documents)

Background epidemiology studies, natural progression of disease studies and user characterization studies

Indicated population cohorts for external controls arms and regulatory requests

Post-approval effectiveness studies and their feasibility assessments

Other epidemiology studies (e.g., special subpopulations, new indications)

Provide critical assessment of epidemiological data and literature

Design and implement multiple database, de novo, or hybrid design studies intended to quantify risks potentially associated with client products

Present and publish results of epidemiological studies at scientific conferences and peer-reviewed journals

Support multiple product teams on epidemiology related issues

Work collaboratively with key stakeholders internally (such as Clinical, Medical, Regulatory) and externally (such as academics, regulators, vendors)

Responsibilities:

Demonstrated ability to conduct high-quality comprehensive literature reviews in the pharmaceutical industry, academia, and/or regulatory agencies

Experience writing epidemiological sections of scientific documents such as research summaries, publications, risk management plans, etc.

Practical experience with implementation of observational or experimental studies

Independently serve as Epidemiology lead of projects with some regulatory/methodologic complexity such as background epidemiology studies; for less complex projects, lead independently with minimal mentorship

Qualifications:

PhD or, MD or PharmD with Master’s degree, and 5+ years of experience in Data Science, Bioinformatics, Clinical Science, Epidemiology, Quantitative Public Health discipline, or related discipline

Strong preference for 3 or more years’ experience in the pharmaceutical industry; extensive track record interacting with R&D and commercial organizations in pharmaceutical industry

Consulting experience in epidemiologic research a plus

Extensive track record and experience in observational and RWD studies and applying epidemiologic methods to clinical research

Demonstrated depth of understanding of observational research methods, regulatory standards, comparative effectiveness research, health care and data science trends, and ability to leverage epidemiologic and data science expertise to meet evolving business needs

Evidence of technical expertise of applying RWD/RWE evidence and insights at the therapy/product level;

Understanding client challenges and soliciting support for new opportunities to build project portfolio

Interpersonal skills to seamlessly interact on both business and scientific issues along with negotiation and facilitation skills to align group decisions

Experienced in managing meetings / projects

Creative skills in designing alternative approaches, new solutions, or innovations

Support standardizing and optimizing processes for ease of implementation

Extensive expertise in RWD/RWE to advice, on disease areas, data, technology, and risk management strategies to development projects and marketed products

Ability to explain strengths and limitations of RWD/RWE datasets such as electronic health records, claims, clinical data registries, patient generated health data, and other health data sources in context of designing RWD/RWE data study designs


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