Global Safety Senior Director, PV Scientist- Obesity

Amgen • Boston, MA

2d

About The Position

Join Amgen’s Mission of Serving Patients 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. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. 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. Global Safety Medical Senior Director, PV Scientist What you will do Let’s do this. Let’s change the world. In this vital role you will provide strategic oversight and direction for all major regulatory safety submissions and responses or strategic deliverables including but not exclusive to Safety sections of NDA submissions, clinical overview, RMPs, PSURs, PBRERs, DSURs, DILs. Leads the safety strategy and Benefit/Risk Management Process for assigned portfolio and provides ongoing monitoring of safety profiles for Amgen products worldwide as well as oversight of these responsibilities for direct reports. Chairs or participates in safety governance meetings per Standard Operating Procedures and Manuals. At the GST meeting, can be delegated by TA Head to endorse decisions for Risk Level 3 risk mitigation and communication actions and is a core team member of the ESC. Serves as a sponsor/oversight and/or SME for functional and/or cross functional projects for process improvement as needed. Product safety profile, benefit-risk evaluation, and risk communication Accountable for the Development and maintenance of core reference safety information (e.g., Development Core Safety Information [DCSI], Core safety information portions of Core Data Sheet [CDS]) Identify relevant data and conduct benefit-risk evaluation Participate in product label process Represent GPS on internal governance bodies for study protocols, statistical analysis plans and other clinical study-related documents and charters including aggregate review of safety data reports Develop a strategy as needed for updating safety-related portions of Investigator’s Brochure and Informed Consent Form Participate in activities related to Data Monitoring Committees (DMCs) and internal data review teams (DRTs) Analyze safety data from clinical studies and contribute to core safety messages and conclusions in clinical study reports and review all sections of CSR as safety delegate Develop strategy for and lead preparation of responses to safety-related inquiries from regulatory agencies and ethics committees Develop signal detection strategy Evaluate safety signal detection findings and validate signals iteratively as needed and document in appropriate management systems. Prepares and presents recommendations on safety issues with medical and indication context including safety data and literature with relevant indication and competitor information, to the Global Safety Team and escalates as appropriate to the executive level cross-functional decision-making body Approves the safety assessment report Ensure timely preparation, content, and quality of new or updated risk management plan (RMP) document Develop a strategy for safety risk minimization measures globally (including US REMS if applicable) Develop materials for additional risk minimization measures as applicable to role Ensure timely preparation and quality of periodic reports (e.g., PSUR/PBRER, DSUR) Review and approve periodic safety reports Author messaging, Reviews and approves filing documents relevant to drug safety Develop a strategy for and lead preparation of response to regulatory agency inquiries on safety topics related to regulatory filings Prepare for and participate in regulatory agency advisory committees Review and assist in development of Pediatric Investigation Plan (PIP) Prepare for and attend health authority meetings involving patient safety issues Participates in safety governance meetings per Standard Operating Procedures and Manuals (e.g. Facilitates, Chairs, Presents) Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness Be representative and point of contact for Health Authority Inspection and Internal Process Audits within the remit of role and responsibility Oversees day to day activities of the Global Safety Officers and Global Safety Physicians as applicable Ensure staff are compliant with Amgen corporate and departmental training and SOP review Provide training, coaching, mentoring, and development of staff Accountable for disseminating and representing corporate and departmental information to staff and ensuring understanding and adherence to changes

Requirements

• Doctorate degree and 5 years of global safety experience OR Master’s degree and 9 years of global safety experience OR Bachelor’s degree and 11 years of global safety experience
• In addition to meeting at least one of the above requirements, you must have at least 5 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources.
• Your managerial experience may run concurrently with the required technical experience referenced above.

Nice To Haves

• MD or DO degree from an accredited medical school with 6 years of directly related experience or PhD with 15 years of directly related experience
• Clinical experience in either an accredited academic setting or private practice (including hospital based) setting
• Experience in Obesity and/or Cardiometabolic conditions
• 4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
• Previous product safety experience

Responsibilities

• Provide strategic oversight and direction for all major regulatory safety submissions and responses or strategic deliverables including but not exclusive to Safety sections of NDA submissions, clinical overview, RMPs, PSURs, PBRERs, DSURs, DILs.
• Leads the safety strategy and Benefit/Risk Management Process for assigned portfolio and provides ongoing monitoring of safety profiles for Amgen products worldwide as well as oversight of these responsibilities for direct reports.
• Chairs or participates in safety governance meetings per Standard Operating Procedures and Manuals.
• At the GST meeting, can be delegated by TA Head to endorse decisions for Risk Level 3 risk mitigation and communication actions and is a core team member of the ESC.
• Serves as a sponsor/oversight and/or SME for functional and/or cross functional projects for process improvement as needed.
• Accountable for the Development and maintenance of core reference safety information (e.g., Development Core Safety Information [DCSI], Core safety information portions of Core Data Sheet [CDS])
• Identify relevant data and conduct benefit-risk evaluation
• Participate in product label process
• Represent GPS on internal governance bodies for study protocols, statistical analysis plans and other clinical study-related documents and charters including aggregate review of safety data reports
• Develop a strategy as needed for updating safety-related portions of Investigator’s Brochure and Informed Consent Form
• Participate in activities related to Data Monitoring Committees (DMCs) and internal data review teams (DRTs)
• Analyze safety data from clinical studies and contribute to core safety messages and conclusions in clinical study reports and review all sections of CSR as safety delegate
• Develop strategy for and lead preparation of responses to safety-related inquiries from regulatory agencies and ethics committees
• Develop signal detection strategy
• Evaluate safety signal detection findings and validate signals iteratively as needed and document in appropriate management systems.
• Prepares and presents recommendations on safety issues with medical and indication context including safety data and literature with relevant indication and competitor information, to the Global Safety Team and escalates as appropriate to the executive level cross-functional decision-making body
• Approves the safety assessment report
• Ensure timely preparation, content, and quality of new or updated risk management plan (RMP) document
• Develop a strategy for safety risk minimization measures globally (including US REMS if applicable)
• Develop materials for additional risk minimization measures as applicable to role
• Ensure timely preparation and quality of periodic reports (e.g., PSUR/PBRER, DSUR)
• Review and approve periodic safety reports
• Author messaging, Reviews and approves filing documents relevant to drug safety
• Develop a strategy for and lead preparation of response to regulatory agency inquiries on safety topics related to regulatory filings
• Prepare for and participate in regulatory agency advisory committees
• Review and assist in development of Pediatric Investigation Plan (PIP)
• Prepare for and attend health authority meetings involving patient safety issues
• Participates in safety governance meetings per Standard Operating Procedures and Manuals (e.g. Facilitates, Chairs, Presents)
• Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness
• Be representative and point of contact for Health Authority Inspection and Internal Process Audits within the remit of role and responsibility
• Oversees day to day activities of the Global Safety Officers and Global Safety Physicians as applicable
• Ensure staff are compliant with Amgen corporate and departmental training and SOP review
• Provide training, coaching, mentoring, and development of staff
• Accountable for disseminating and representing corporate and departmental information to staff and ensuring understanding and adherence to changes

Benefits

• As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being.
• From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.
• 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, and 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 where possible.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees