Senior Director, Patient Safety (MD)

Gilead Sciences•Parsippany, NJ

9d•Remote

About The Position

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.

Requirements

MD Degree or equivalent; board eligible plus 12 years of relevant experience
8+ years of drug safety/pharmaceutical industry or clinical practice experience with extensive PV expertise in one or more therapeutic area
Significant knowledge of EU and FDA PV guidelines, GCP and clinical research methodology
Extensive and demonstrated leadership including problem solving, negotiation, organization and planning skills
Demonstrated effective written and verbal communication skills
Proficiency with MS Word, Excel, and PowerPoint
Proven scientific/clinical and analytical knowledge base with ability to assess data and understand the safety/medical implications
Solid understanding of pharmacoepidemiology and ability to provide sound critique of observational studies

Nice To Haves

MD Degree or equivalent; board certification plus 12 years of relevant experience
Oncology or Immunology experience
CarT experience

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 surveillance programs, aggregate review and risk management planning
Collaborates with drug safety's risk management team in proactive identification and assessment of safety signals and trends, and supports management of any potential safety issues
Executes process change and initiatives based on deep understanding of GVP and other regulatory guidance
Participates in SOP updates, audits, data analysis and other ad hoc activities
Communicates to highest levels of senior management key pharmacovigilance findings
Provides global medical leadership for product focused safety activities
Provides global strategic input to organization to mitigate pharmacovigilance-related risk