Director, Medical Review (MR)

Director, Medical Review (MR)
United States - California - Foster City

Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead’s therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.

Making an impact on a global scale
Inclusion is one of the company’s five core values. That’s because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.

When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.

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 manage and oversee the medical review of individual case safety reports (ICSRs) and line listings, for marketed and investigational products, providing medical safety assessment and pharmacovigilance comment. You will also manage audits and peer retrospective medical review quality control (MRQC) activities.

EXAMPLE RESPONSIBILITIES:

• Establishes recognition as an expert on medical safety assessment of individual cases and line listings.
  
• Performs peer retrospective quality control (QC) of adverse event reports from a medical review perspective.
  
• Participates in both internal and external educational initiatives.
  
• Initiates, leads, or contributes to a functional or cross-functional project.
  
• Participates in process improvement initiatives by identifying areas for improvement and presents solutions.
  
• Collaborates with global safety leads (GSLs) and global safety strategy leads (GSSLs) on select cases with suspected unexpected serious adverse reactions (SUSARs) from clinical trials.
  
• May serve on higher level intradepartmental and interdepartmental cross-functional projects.
  
• May lead or contribute to develop and maintain procedural document and provide training.
  
• Supports internal and external audit and inspection.
  
• Provides medical consultation to Patient Safety (PS) Strategic Operations group including Literature Management, Coding Strategy, and Autolabeling Management on an ad hoc basis.
  
• Provides mentorship and trains junior staff, new hires, and contractors to independently review adverse event reports for investigational and marketed products.
  
• Responds to medical review-related questions from other functions in a timely manner.
  
• Makes contributions to process improvement within PS, particularly with adverse event processing and operational aspects of medical review.
  
• May recruit, hire, mentor, and manage direct reports, with responsibility for team members' performance evaluations.
  
• Participates in the biweekly Medical Review team meetings.
  
• Provides medical input to Strategic Operations on case queries.
  
• Plays a leadership role by providing medical review support for other functional groups.
  
• Makes significant contributions to the ongoing development and refinement of medical review processes, standards, practices, efficiencies, and capabilities.
  
• Directs and oversees development of new procedures and relevant medical review strategies.
  
• Ensures meticulous adherence to deadlines. Anticipates events which might impact deadlines and mitigates accordingly.
  
• Oversees development of medical review activities and inform management decision-making.
  
• May participate as Medical Review representative in audits/inspections.
  
• When needed, prioritizes work and delegates to other MR colleagues.
  
• Leads internal MR projects and represents MR on cross-functional projects.
  
• Ensures appropriate and timely collaboration between MR and other groups for medical review activities.
  
• May have one or more direct reports.
  
• Provides accurate and thorough input and recommendations into resource plans required to complete own deliverables.
  
• Ensures own work complies 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

• Requires an MD/DO degree or equivalent.
  
• Requires completion of an accredited medical or surgical residency program. Board certification is preferred.
  
• Should have either (1) minimum of 4 years' experience in medical review or (2) an applicable role in the pharmaceutical industry with a general understanding of relevant regulatory requirements or an exceptional track record of excellence in clinical practice.
  

Rest of World Education & Experience

• MD/DO or equivalent. Significant drug safety or related experience in the biopharma industry, at a regulatory agency, clinical research or related medical / healthcare environment.
  

Knowledge & Other Requirements

• Excellent scientific/clinical and analytical knowledge base, with ability to assess individual case safety reports and understand the safety/medical implications.
  
• Ability to communicate to high level stakeholders under tight deadlines and to manage multiple major projects simultaneously.
  
• Ability to assume increasing scope and complexity, as evidenced by past successes with team and project leadership, strategic cross-functional partnering, and key contributions to strategy, operational and infrastructure development.
  
• Independence in effectively managing teams.
  
• Strong leadership presence with demonstrated ability to lead without authority and influence programs, projects and/or initiatives.
  
• Ability to handle increasing and/or changing responsibilities (e.g., team growth, integration efforts across other functions or the organization)
  
• Strong interpersonal skills and understanding of team dynamics.
  
• Strong communication and organizational skills. Demonstrable abilities to effectively communicate project direction and status to varying organizational levels, including leadership teams, executives, and steering committees.
  
• Strong negotiation and conflict resolution skills.
  
• Strong coaching capabilities to mentor/develop staff.
  

The salary range for this position is: $237,660.00 - $307,560.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.

For additional benefits information, visit:

https://www.gilead.com/careers/compensation-benefits-and-wellbeing

* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

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As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.com for assistance.

For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.

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Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.

Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.






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