Director, Epidemiology – Neuroscience

Job not on LinkedIn

Yesterday

🔔 Pennsylvania – Remote

Although this job is listed in Pennsylvania, this company may be open to hiring remote in other states.

💵 $164k - $282.9k / year

⏰ Full Time

🔴 Lead

👔 Director

🦅 H1B Visa Sponsor

Apply Now

Receive Emails with Similar Jobs

OneTrust

WebsiteLinkedInAll Job Openings

Compliance • Cybersecurity • Data & AI Governance

OneTrust is a comprehensive platform that empowers organizations to responsibly collect, govern, and utilize data with complete visibility and control. It provides solutions for consent and preference management, third-party risk management, privacy automation, and tech risk compliance, ensuring adherence to regulatory standards while fostering innovation. By helping businesses manage their data lifecycle effectively, OneTrust helps safeguard data from various risks including privacy concerns and IT vulnerabilities, thus maximizing the value of data and AI in line with organizational policies.

1001 - 5000 employees

📋 Compliance

🔒 Cybersecurity

💰 $6.4M Venture Round on 2022-07

📋 Description

• Lead epidemiology support for lumateperone (CAPLYTA) and our portfolio of depression-related compounds in development. • Lead the implementation of the REWARD initiative, an ambitious collaborative effort using observational database analyses to enable exploration and identification of differentiated benefits of medical products to support R&D's clinical development strategy. • Identify research study needs, draft proposals and protocols, and contribute to real-world evidence (RWE) strategy and study conduct across the neuroscience therapeutic area portfolio. • Lead RWE generation to support regulatory activities and inform decisions made by Global Medical Safety (GMS). • Work closely in collaboration with colleagues in the Epidemiology group when defining research questions, developing epidemiological protocols, conducting analyses, and interpreting and communicating evidence to internal and external stakeholders. • Participate in various multi-disciplinary matrix teams to address issues raised by product teams/regulatory agencies where real-world data (RWD)/RWE can inform decisions. • Provide epidemiological and/or statistical consulting and support to compound/product teams, and disseminate technical information through reports, presentations, and publications in peer-reviewed literature as agreed by the team. • Work within and outside of existing electronic databases to: assess feasibility of fit-for-purpose RWD; research natural history of diseases to understand background event rates in the indicated population expected with standard of care; perform statistical risk assessments; use historical clinical trial data and other data sources to contextualize potential safety issues for new medications; support benefit-risk assessments throughout the product lifecycle; design and conduct post-authorization safety activities, including rapid analytics for signal strengthening and formal required/committed evaluation studies, as part of Pharmacovigilance and Risk Management Plans. • Support efforts for the Office of the Chief Medical Officer (OCMO) and cross-sector collaborations, as prioritized. • Promote the use of standardized tools to support real world evidence generation across functions utilizing RWE as part of the Integrated Evidence Generation Plan. • Keep up to date with changes in the external environment, including working through professional society and public-private consortia to advocate as a subject matter expert, regarding RWE guidance/framework for regulatory decision making.

🎯 Requirements

• A minimum of a Master’s degree in Epidemiology or related discipline is required. • A Ph.D. or M.D. in Epidemiology or related discipline is preferred. • A minimum of 6 years of Epidemiology research experience with a Master’s degree or a minimum of 5 years of Epidemiology research experience with a Ph.D. or M.D. is required. • Understanding of the epidemiologic landscape of specific diseases, conditions, or therapies is required. • Experience writing observational study protocols, proposals, and proposal requests, particularly the methods sections, is required. • Experience working with Health Authorities is preferred. • Understanding and ability to apply and interpret quantitative methods is required. • A minimum of 1 year of experience in statistical programming (e.g. R) is required. • A minimum of 1 year of database programming (e.g. SQL) in large healthcare databases is required. • Experience with developing R Shiny apps is required. • Product development experience in the pharmaceutical industry is preferred. • Knowledge of the Neuroscience therapeutic area is preferred. • A track record of authoring scientific communications (peer-reviewed publications, poster or oral presentations at conferences, technical reports) is required. • Must have excellent verbal and written communication skills. • The ability to collaborate with all levels in a global, cross-functional team environment is required.

🏖️ Benefits

• medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance • consolidated retirement plan (pension) and savings plan (401(k)) • Vacation - up to 120 hours per calendar year • Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year • Holiday pay, including Floating Holidays - up to 13 days per calendar year • Work, Personal and Family Time - up to 40 hours per calendar year