3 дня назад
Head of Benefit-Risk and Pharmacoepidemiology
293 250 - 423 583$
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Head of Benefit-Risk and Pharmacoepidemiology (Pharmacovigilance): Leading epidemiology and benefit-risk strategies, safety studies, and risk assessments for medicines across development and post-marketing with an accent on real-world data, regulatory requirements, and scientific leadership. Focus on building a world-class multidisciplinary team, advancing safety analytics and methods, and shaping external policy through partnerships with regulators, academia, and industry.
Location: Morristown, New Jersey, United States; hybrid work. The role is for U.S. and Puerto Rico residents only and may require up to 25% travel.
Salary: $293,250–$423,583 per year.
Company
is a biopharmaceutical company developing medicines through patient-focused drug development, immunoscience, AI, data, and digital platforms.
What you will do
- Lead epidemiology and benefit-risk strategies for products across discovery, development, and post-marketing stages.
- Oversee epidemiology safety studies, including PASS, to meet regulatory requirements.
- Lead epidemiology risk assessments and structured benefit-risk evaluations for senior safety governance bodies.
- Manage the Benefit-Risk and Pharmacoepidemiology team, including capability building, career development, and budget oversight.
- Develop processes for rapid access to real-world data sources supporting safety evaluation.
- Lead external partnerships, scientific communications, and collaborations with regulators, academia, and industry.
Requirements
- Doctoral degree in biomedical sciences or public health, or an M.D. with an advanced degree in a related field, preferred.
- At least 15 years of relevant professional experience with a Ph.D., or 12 years with an M.D.; at least 8 years in the pharmaceutical industry preferred.
- Experience in epidemiology, benefit-risk evaluation, risk management, signal detection and management, and patient safety sciences.
- Leadership experience with external partnerships, scientific publications, multidisciplinary teams, and complex processes.
- Strong statistics, biostatistics, critical analytics, real-world data, and regulatory knowledge, including ICH, CIOMS, FDA, EU, PASS, RMP, data privacy, registries, and ENCePP guidelines.
- U.S. and Puerto Rico residency is required; up to 25% travel may be required.
Culture & Benefits
- Supportive, future-focused environment with opportunities for promotion and international or lateral career moves.
- Employee rewards and benefit programs, including healthcare, prevention, and wellness programs.
- At least 14 weeks of gender-neutral parental leave.
- Patient insights are used early in drug development to design studies reflecting real-world needs.
- Access to cutting-edge AI, data, and digital platforms for drug discovery.
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