9 дней назад
Executive Director, Global Patient Safety Sciences - Rare Disease (Biotechnology)
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Executive Director, Global Patient Safety Sciences - Rare Disease (Biotechnology): Leading global patient safety strategy for rare disease products across clinical and post-marketing stages with an accent on safety signal evaluation, benefit-risk assessment, and regulatory responses. Focus on providing medical oversight, aligning cross-functional governance, and building a high-performing global patient safety organization.
Location: Tarrytown, New York, United States; on-site four days per week. Up to 25% travel may be required.
Company
is a biotechnology company that discovers, develops, and commercializes medicines for serious diseases, including rare diseases.
What you will do
- Define the product safety strategy and provide the medical safety opinion for the Rare Disease portfolio across clinical and post-marketing stages.
- Serve as the therapeutic area and product safety subject matter expert for GPS and non-GPS interactions.
- Review complex individual case safety reports, safety signals, emerging safety issues, benefit-risk assessments, and product safety documentation.
- Provide medical oversight for Risk Management Plans, health authority responses, and safety monitoring activities.
- Represent Global Patient Safety at governance forums, data monitoring committees, strategic program teams, and external collaborator meetings.
- Build, coach, and scale the GPS Leads team while driving succession planning and leadership development.
Requirements
- Minimum M.D., PA, PhD, or PharmD degree; board certification or an equivalent relevant clinical specialty is preferred.
- 17+ years of experience in pharmacovigilance or relevant clinical experience in the pharmaceutical industry.
- 6+ years of team leadership and people management experience, preferably in a matrixed environment.
- Experience developing product safety profiles, conducting safety assessments and risk evaluations, and supporting decision-making.
- Experience overseeing strategy within a global patient safety organization and managing multiple projects.
- Strong leadership, communication, organizational, and workload-planning skills.
Nice to have
- MBA.
- 1–3 years of international pharmaceutical experience.
- Experience with AI technologies.
Culture & Benefits
- Inclusive workplace with equal employment opportunities and reasonable accommodations where required.
- Comprehensive rewards may include annual bonuses, equity awards, retirement benefits, health and wellness programs, insurance, paid time off, and family support benefits.
- Some roles include access to fitness centers and a 401(k) company match.
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