Global Safety Physician, Senior Medical Scientist- Rare Disease

Amgen • Washington, DC

278d • Hybrid

About The Position

At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Requirements

• Doctorate degree and 2 years of relative experience OR Master's degree and 4 years of relative experience OR Bachelor's degree and 6 years of relative experience OR Associate's degree and 10 years of relative experience OR High school diploma / GED and 12 years of relative experience.

Nice To Haves

• MD, DO, or equivalent degree from an accredited medical school plus 2 years of directly related experience.
• MD from a foreign medical school.
• Clinical/medical research experience.
• Product safety in the bio/pharmaceutical industry.
• Previous management and or mentoring experience.
• Experience in leading teams and or projects.

Responsibilities

• Serve as the medical expert of the team to support the Global Safety Officer (GSO) in the conduct of quality safety assessment and risk management processes and activities for an assigned set of products through the product's life cycle.
• Conduct safety monitoring and execute all product related safety decisions and deliverables for assigned products as designated by leadership.
• Advise the planning, preparation, writing and review of portions of aggregate reports.
• Review and provide input and support on study protocols, statistical analysis plans and other clinical study-related documents.
• Review AEs/SAEs from clinical trials as needed.
• Review standard design of tables, figures, and listings for safety data from clinical studies.
• Participate in development of safety-related data collection forms for clinical studies.
• Participate in study team meetings.
• Perform data analysis to evaluate safety signals and write up analysis results.
• Author Safety Assessment Reports and other safety documents and regulatory responses in collaboration with the GSO.
• Search and review adverse event data, literature, and other safety-relevant data for the purpose of signal detection.
• Prepare presentation of the Global Safety Team's recommendations on safety issues to the cross-functional decision-making body.
• Provide contents for risk management plans.
• Develop or update strategy and content for regional risk management plans.
• Assist GSOs to coordinate risk minimization activities including tracking of activities as needed.
• Evaluate risk minimization activity.
• Prepare response to regulatory inquiries related to risk management plans under the guidance of GSO.
• Assist GSO in developing a strategy for safety-related regulatory activities.
• Provide safety contents for filings.

Benefits

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions.
• Group medical, dental and vision coverage.
• Life and disability insurance.
• Flexible spending accounts.
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan.
• Stock-based long-term incentives.
• Award-winning time-off plans.
• Flexible work models, including remote and hybrid work arrangements.

What This Job Offers

• Career Level: Senior
• Industry: Chemical Manufacturing
• Education Level: Ph.D. or professional degree