5 дней назад
Senior Director, Patient Safety (MD) (Oncology)
255 425 - 330 550$
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Senior Director, Patient Safety (MD) (Oncology) (Pharmacovigilance): Leading global medical safety strategy for oncology and immunology products, including surveillance, aggregate review, risk management planning, and regulatory engagement with an accent on safety signal assessment and product-focused pharmacovigilance. Focus on evaluating clinical and observational data, shaping regulatory decisions, managing safety risks, and leading process improvements under FDA and EU pharmacovigilance guidance.
Location: Parsippany, New Jersey, United States
Salary: $255,425–$330,550 per year for other U.S. locations. Bay Area range: $281,010–$363,660 per year.
Company
is a biopharmaceutical company developing CAR T-cell and T-cell receptor engineered therapies for cancer immunotherapy.
What you will do
- Provide medical strategy and safety input for regulatory decisions, advisory panels, and stakeholder meetings.
- Lead pharmacovigilance strategy for assigned products or therapeutic areas, including surveillance, aggregate review, and risk management planning.
- Identify and assess safety signals and trends with drug safety risk management teams.
- Lead product-focused safety activities and communicate key findings to senior management.
- Drive process changes, SOP updates, audits, data analysis, and initiatives based on GVP and regulatory guidance.
- Provide strategic input to mitigate pharmacovigilance-related risks.
Requirements
- MD degree or equivalent, board eligible, with 12 years of relevant experience.
- At least 8 years of drug safety, pharmaceutical industry, or clinical practice experience with extensive pharmacovigilance expertise.
- Significant knowledge of EU and FDA pharmacovigilance guidelines, GCP, and clinical research methodology.
- Strong leadership, problem-solving, negotiation, organization, planning, and communication skills.
- Scientific, clinical, and analytical expertise, including the ability to assess data and medical safety implications.
- Understanding of pharmacoepidemiology and the ability to critically evaluate observational studies; proficiency with Microsoft Word, Excel, and PowerPoint.
Nice to have
- Board certification.
- Oncology or immunology experience.
- CAR T experience.
Culture & Benefits
- People leadership focused on inclusion, talent development, and team empowerment.
- Medical, dental, vision, and life insurance plans.
- Paid time off and potential eligibility for an annual bonus.
- Potential eligibility for discretionary stock-based long-term incentives.
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