Senior Director, Medical Review
Welcome to Gilead Sciences, where our mission is to advance the care and treatment of patients suffering from life-threatening diseases. We are seeking a highly skilled and experienced Senior Director of Medical Review to join our dynamic team. In this role, you will have the opportunity to make a significant impact by overseeing and directing the medical review process for our innovative products. This is a unique opportunity for a driven and visionary leader to contribute to the success of our organization and positively impact the lives of patients worldwide. If you have a passion for advancing medical breakthroughs and possess the qualifications and experience outlined below, we encourage you to apply.
- Oversee and direct the medical review process for all Gilead Sciences products.
- Ensure that all medical review activities are conducted in accordance with company policies and procedures, as well as regulatory requirements.
- Provide strategic direction and guidance to the medical review team.
- Develop and implement processes to improve the efficiency and effectiveness of the medical review process.
- Collaborate with cross-functional teams, including medical affairs, clinical development, regulatory affairs, and commercial teams, to ensure alignment and consistency in medical review activities.
- Stay up-to-date with the latest developments in disease areas and medical treatments to inform and guide medical review decisions.
- Manage a team of medical review professionals, providing leadership, mentorship, and support.
- Ensure timely and accurate completion of medical review activities, including review of clinical trial data, safety reports, and regulatory submissions.
- Work closely with external partners, such as contract research organizations, to oversee and manage outsourced medical review activities.
- Represent Gilead Sciences in external meetings and forums related to medical review and participate in the development of industry standards and best practices.
- Identify and mitigate potential risks related to medical review activities.
- Develop and maintain relationships with key stakeholders, including key opinion leaders, healthcare providers, and patient advocacy groups.
- Contribute to the development and implementation of medical review training programs for internal and external stakeholders.
- Participate in the review and interpretation of medical data for regulatory submissions and publications.
- Ensure compliance with all relevant laws, regulations, and guidelines related to medical review activities.
- Support the development and implementation of medical review policies and procedures.
- Provide strategic input and recommendations for the development of new products and indications.
- Monitor and analyze medical review metrics to identify areas for improvement and inform decision-making.
- Stay informed about the competitive landscape and provide insights and recommendations to support business objectives.
- Uphold the values and mission of Gilead Sciences
Advanced Medical Degree: A Senior Director, Medical Review At Gilead Sciences Should Possess An Advanced Medical Degree, Such As An Md Or Phd, With A Specialization In A Relevant Field Such As Pharmacology Or Clinical Research.
Extensive Experience In Medical Review: The Ideal Candidate For This Position Should Have A Minimum Of 10 Years Of Experience In Medical Review, Preferably In A Leadership Role Within A Pharmaceutical Or Biotech Company.
In-Depth Knowledge Of Regulatory Guidelines: Gilead Sciences Is A Highly Regulated Industry, Therefore, The Senior Director, Medical Review Should Have A Thorough Understanding Of Global Regulatory Guidelines And Requirements, Including Ich-Gcp And Fda Regulations.
Strong Leadership And Management Skills: As A Senior Leader Within The Organization, The Candidate Should Have A Proven Track Record Of Effectively Managing And Leading A Team, With The Ability To Mentor And Develop Staff To Achieve Their Full Potential.
Excellent Communication And Collaboration Skills: The Senior Director, Medical Review Will Be Responsible For Interacting With Cross-Functional Teams, External Partners, And Regulatory Agencies. As Such, The Candidate Must Possess Excellent Communication And Collaboration Skills To Effectively Convey Complex Medical Information And Build Strong Relationships.
Quality Assurance
Strategic Planning
Project Management
Data Analysis
Team Management
Budget management
Leadership
Risk assessment
Regulatory compliance
Cross-Functional Collaboration
Medical Writing
Clinical Knowledge
Communication
Conflict Resolution
Leadership
Time management
creativity
flexibility
Teamwork
Adaptability
Problem-Solving
Empathy
According to JobzMall, the average salary range for a Senior Director, Medical Review in Parsippany-Troy Hills, NJ, USA is between $189,000-$202,000 per year. However, this may vary depending on the specific company, industry, and level of experience of the individual.
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Gilead Sciences, Inc., is an American biotechnology company that researches, develops and commercializes drugs. The company focuses primarily on antiviral drugs used in the treatment of HIV, hepatitis B, hepatitis C, and influenza, including Harvoni and Sovaldi.
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