Senior Director, Medical Review (MR)

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Job description

Senior Director, Medical Review (MR)
United States - New Jersey - ParsippanyUnited 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

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

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 clinical safety, pharmacovigilance operations, and medical review. Oncology experience preferred.
• Line management (direct reports) experience is strongly preferred.
• Proven track record of effective people leadership, as evidenced through past effectiveness with employee engagement, development and retention either with direct reports or through matrix leadership responsibilities.
• Strong track record of cultivating and maintaining strategic relationships and collaborations both internally and externally.

Rest of World Education & Experience

• MD / DO or equivalent with completion of an accredited medical or surgical residency program. Board certification is strongly preferred. Significant experience working in drug safety / PV or a related field in the biopharma industry, clinical research, health administration, health policy, epidemiology, or academic or subspeciality medicine. Biopharma industry experience is preferred.

Knowledge & Other Requirements

• Knowledge of the drug development process, Good Clinical Practices (GCP) and Good Pharmacovigilance (GVP), including worldwide PV regulations and their application to individual case safety reports.
• Excellent scientific/clinical and analytical knowledge base, with ability to assess individual case safety reports and understand the safety/medical implications.
• Leadership skills including problem solving, negotiation skills, organization, and planning.
• Proven ability to manage global teams.
• Proven abilities to make significant contributions to Patient Strategy (PS) strategic planning and lead significant process improvements in PS.
• Exceptional 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. Able to distill complex matters into a clear business case and roadmap for execution.
• Strong negotiation and conflict resolution skills.
• Strong coaching capabilities to mentor/develop staff.

The salary range for this position is: $249,645.00 - $323,070.00. 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:

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 . click apply for full job details

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