Gilead

Senior Director, Patient Safety (MD)

United States New Jersey ParsippanyFull timeDirector$255,425 - $330,550 / yearPosted 12 days ago
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We’re here for one reason and one reason only – to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We’ve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're not finished yet.Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next.We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Kite and help create more tomorrows.Job DescriptionWe’re here for one reason and one reason only – to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We’ve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're not finished yet.Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next.We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Kite and help create more tomorrows.Key Responsibilities:Provides medical strategy and input into key regulatory decisions pertaining to safety of multiple products , including representing safety at advisory panels and meetings with regulators or other internal and external stakeholders.Establishes the direction for pharmacovigilance activities for assigned products and provides global medical leadership and input into all aspects of safety for assigned molecule or therapeutic area including surveillanceprograms, aggregate review and risk management planningCollaborates with drug safety's risk management team in proactive identification and assessment of safety signals and trends, and supports management of any potential safety issuesExecutes process change and initiatives based on deep understanding of GVP and other regulatory guidanceParticipates in SOP updates, audits, data analysis and other ad hoc activitiesCommunicates to highest levels of senior management key pharmacovigilance findingsProvides global medical leadership for product focused safety activitiesProvides global strategic input to organization to mitigate pharmacovigilance-related riskMinimum Qualifications:MD Degree or equivalent; board eligible plus 12 years of relevant experience8+ years of drug safety/pharmaceutical industry or clinical practice experience with...