R-01301021 Executive Epidemiology Researcher - Safety Outcomes, Evidera

Thermo Fisher Scientific

226d • Remote

About The Position

At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future. The Executive Epidemiology Researcher acts as the independent principal investigator (PI) of projects responsible for overseeing all aspects of delivery of retrospective studies using secondary data sources (e.g., EMR, claims, registries) to assess safety outcomes related to drug exposure. This may also include hybrid studies involving de novo data collection. Oversees and participates in a large project portfolio, with a focus on pharmacoepidemiology, treatment patterns, and safety outcomes. This may include RWE research voluntary or mandated by regulatory agencies such as pregnancy and fetal outcomes studies, PASS, and PAES studies for the FDA, EMA, or other agencies. Acts as subject matter expert in strategic consultations and provides expertise on scientific methods. Innovates scientifically and produces output of high scientific quality. Assumes responsibilities for sales targets and client development.

Requirements

• Master's or PhD in Epidemiology or Public Health with a minimum of 10 years' pharmaceutical experience, including experience as a consultant with a pharmacoepidemiology or health economics and outcomes research (HEOR) focus.
• Advanced understanding of epidemiology/pharmacoepidemiology within safety outcomes studies, including PASS and PAES studies for the FDA, EMA, or other agencies.
• Understanding of statistics and experience in practical research implementation.
• Proven experience in executing safety studies using large secondary data sources in the US, UK and Europe such as medical claims, electronic health records or registries.
• Proven record of relevant publications in peer reviewed journals and key scientific conferences.

Nice To Haves

• Extensive knowledge of drug development process, evidence requirements and regulatory commitments, in particular in the US (FDA) or Europe (EMA).
• Desire and ability to guide and coach junior-to mid-to levels of scientific staff.

Responsibilities

• Independent PI of a large portfolio of projects, responsible for overseeing all aspects of proposals and project delivery.
• Responsible for project completion and quality delivery. Delegate's coordination tasks to mid-level and junior staff.
• Responsible for sales target, with accompanying expectation around client/business development.
• Contributes to strategic thinking around sales and product development.
• Identifies training needs for junior staff, helps to develop relevant training materials, provides recommendation on appropriate staff to lead trainings, and serves as hands-on mentor.
• Co-authors abstracts/articles for scientific publication in journals or presentation at scientific meetings.

Benefits

• Competitive remuneration
• Annual incentive plan bonus
• Healthcare
• Range of employee benefits

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Computer and Electronic Product Manufacturing
• Education Level: Ph.D. or professional degree