Global Safety Medical Dir, Hematology/Oncology

Amgen is seeking a Global Safety Medical Director at its main headquarters in Thousand Oaks, CA or at its location in Cambridge, MA to join the Global Patient Safety (GPS) organization reporting to the Executive Medical Director Global Safety.

The Global Safety Therapeutic Areas serve as the safety experts for all Amgen products globally and are accountable for the safety strategy and major safety deliverables for each Amgen product. Leaders in the therapeutic area safety teams are accountable for the staff management and resource allocations in Global Patient Safety and support GPS in the establishment of a highly effective global safety organization in full compliance to worldwide regulations.

The Global Safety Officer (GSO) serves 2 roles:

• Safety expert of the assigned product(s), establishing the strategy, direction, and priorities of pharmacovigilance activities. The GSO is accountable for the overall safety profile and all product-related decisions and deliverables for assigned products.
• The GSO leads the Safety Analysis Team (SAT), Global Safety Team (GST) and is a core member of the Executive Safety Committee (ESC). The GSO also is a member of the Evidence Generation Team and other relevant cross functional teams. The GSO will be assigned as delegate for the TAH as needed.

Key Activities

Applicable tasks may vary by product(s) assigned. Medically relevant activities requiring input can be delegated to the Global Safety Physician while remaining accountable for the activities (e.g. validate a signal).

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

Clinical trial safety
• Represent GPS on internal governance bodies for study protocols, statistical analysis plans and other clinical study-related documents
• 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 review clinical study reports as needed
• Develop strategy for and lead preparation of responses to safety-related inquiries from regulatory agencies and ethics committees

Signal detection, evaluation, and management
• Develop signal detection strategy
• Evaluate safety signal detection findings validate signals and determine a need and develop a strategy for further analysis
• Decide on need for further actions on safety issues and lead cross-functional discussion
• Documents work as required in the safety information management system
• Prepares and presents recommendations on safety issues to the Global Safety Team and escalates as appropriate to the executive level cross-functional decision-making body
• Approves the safety assessment report
• May search and review adverse event data, literature, and other safety-relevant data for the purpose of signal detection
• Documents work as required in the safety information management system

Risk management and minimization
• 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

Periodic (aggregate) safety reporting
• Ensure timely preparation and quality of periodic reports (e.g., PSUR/PBRER, DSUR)
• Review and approve periodic safety reports

New drug applications and other regulatory filings
• Review and approve 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
• Review and assist in development of Pediatric Investigation Plan (PIP)
• Prepare for and attend health authority meetings involving patient safety issues

Safety Governance Leadership
• Participates in safety governance meetings per Standard Operating Procedures and Manuals (e.g. Facilitates, Chairs, Presents)

Amgen commercialization process
• Represents and contributes on behalf of Global Patient Safety on Evidence Generation Teams

Inspection Readiness
• 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
Partnerships and integration activities
• Participate in safety agreement development and review process
• Prepare safety information to support licensing partners, review safety documents prepared by licensing partners, and communicate with licensing partners on safety matters per the safety agreement
• Perform safety due diligence in preparation for partnerships, etc.
• Participate in integration activities

Other Amgen processes
• Interact with external stakeholders (e.g., advisory boards) on safety-related topics
• Prepare for and participate in regulatory agency advisory committees
• Provide safety input to support legal needs

Knowledge and Skills

• Processes and regulations for pharmacovigilance and risk management
• Advanced understanding of interfaces across various pharmacovigilance and risk management processes
• Drug development and lifecycle management
• Safety data capture in clinical development and post-market settings
• Safety database structure and conventions
• MedDRA and other dictionaries used in pharmacovigilance
• Methods of qualitative and quantitative safety data analysis
• Product and disease state knowledge
• General medicine, epidemiology, physiology, and pharmacology
• Internal organizational and governance structure
• Inter-relationship across various pharmacovigilance processes and documents, including reference safety information and product labeling
Pharmacovigilance skills
• Signal detection and evaluation
• Aggregate data analysis
• Good clinical and scientific judgment
• Application of medical concepts and terminology
• Document writing and source document review
• Data interpretation and synthesis
• Basic skills in application of statistical and epidemiological methods to pharmacovigilance
• Ability to convey complex, scientific data in an understandable way
• Ability to analyze and interpret complex safety data
• Advanced skills in application of statistical and epidemiological methods to pharmacovigilance
Other skills
• Strategic thinking
• Effective team and strategic leadership, influencing, and negotiation in a cross-functional, matrix environment
• Big picture perspective and context analysis
• People and team management
• Conflict management
• Organization, prioritization, and planning of work
• Project management
• Critical scientific assessment and problem solving
• Oral presentation skills
• Written communications and medical/scientific writing

Basic Qualifications

• MD degree or equivalent (eg, DO or MB) required;
• Four years or more of clinical experience and/or Industry experience is required, with a focus on patient safety or prior pharmacovigilance experience preferred;

Preferred Qualifications

• Product safety in the bio/pharmaceutical industry or regulatory agency
• Previous management and/or mentoring experience
• Board Certification or equivalent training
• Expertise in Hematology/Oncology
• Open to candidates located also in Cambridge, MA or South San Francisco area.

Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission - to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do.

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.