Senior Director, Medical Review (MR)

For Current Gilead Employees and Contractors:

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At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
 

Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.
 

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 Gilead and help create possible, together.

Job Description
 

You will establish visions and objectives for the Medical Review (MR) group taking into consideration of the departmental short- and long-term goals, lead the MR group to deliver timely and high-quality medical review, ensure the MR process and procedure in alignment with regulatory requirements, and provide strategic medical input to Strategic Operations as well as Patient Safety.

EXAMPLE RESPONSIBILITIES:

• Leads the MR group and sets clear and advanced goals for the group.

• Develops and refines MR strategies, processes, standards, practices, efficiencies, and capabilities to meet regulatory requirements and beyond. This includes the process and strategy for causality and labelling assessment of Individual Case Safety Reports (ICSRs), analysis of similar events, and IND Safety Reporting determination.

• Recruits, develops, and maintains key talent medical reviewers.

• Coaches direct reports on their performance, development and career interests.

• Provides medical input to Strategic Operations and Patient Safety that influences the direction and effectiveness of the organization overall.

• Responds to medical review-related questions from regulatory agency or other functions within the Company in a timely manner.

• Plays a leadership role in Patient Safety cross-functional teams.

• Communicates to highest levels of senior management key pharmacovigilance findings.

• Oversees or performs medical review of individual case safety reports (ICSRs) and line listings for investigational and marketed products as needed.

• Oversees or performs peer retrospective medical review quality control (MRQC) for individual case safety reports and line listings. 

• Provides medical consultation to Patient Safety (PS) Strategic Operations groups including Literature Management, Coding Strategy, and Autolabeling Management on an ad hoc basis.

• Organizes regular Medical Review team meetings and promotes learning.

• Develops and maintains MR related procedural documents.

• Ensures meticulous adherence to deadlines. Anticipates events which might impact deadlines and mitigates accordingly.

• Represents MR in audits/inspections.

• Ensures appropriate and timely collaboration between MR and other groups for medical review activities.

• Provides accurate and thorough input and recommendations into resource plans required to complete own deliverables.

• Ensures the team and the assigned work comply with established practices, policies, and processes and any regulatory or other requirements.

REQUIREMENTS:

We are all different, yet we all use our unique contributions to serve patients. Please see the following for the qualifications and skills we seek for this role.

U.S. Education & Experience

• MD/DO degree or equivalent.

• Completion of an accredited medical or surgical residency program is required. Board certification is preferred.

• A minimum of 6 years’ experience in pharmacovigilance with substantial knowledge of drug safety including medical review of ICSRs.

• Extensive knowledge of US and global ICSR medical review regulations and IND Safety Reporting.

• Industry experience of cl