Executive Director, Head of Safety Signal and Risk Management (Open to remote)

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Posted 2 days ago United States Salary undisclosed
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Job Description

At Amgen, every challenge is an opportunity. And every opportunity brings the potential to change lives. Our shared missionto serve patientshas driven our status as one of the worlds preeminent biotechnology companies, reaching over 10 million patients worldwide. Leverage your high-level expertise to lead and forge partnerships that advance the biotechnical and biopharmaceutical science that can turn the tide of serious, life-interrupting illnesses.

Executive Director, Head of Safety Signal and Risk Management

What you will do
This position sets department direction and strategy for signal detection, benefit: risk and risk management activities. The Executive Director is responsible for driving policies, research, definition and implementation of innovation and best practices for safety data mining, signal detection planning, management, tracking; risk management practices, benefit/risk assessment and safety communications while ensuring quality processes with proven metrics to support Amgen Global Patient Safetys mission of ensuring the safe and appropriate use of Amgen products. This position is also accountable for the staff management and resource planning/allocation. As a core member of GPS SLT committee supports the Head of GPS in the establishment of a highly effective global safety organization in full compliance to worldwide regulations. This position will offer relocation to Thousand Oaks, CA or may possibly offer a remote working situation.

Responsibilities Include:

Safety Signal and Risk Management Process Management and Oversight:
  • Provides leadership in the development of processes and best practices for signal detection strategies, benefit: risk- evaluation and minimization activities and ensures effective management, technological expertise and scientific input to these polices and processes
  • Works in close coordination with the Head of Global Patient Safety and Safety TA Heads on critically interdependent assessment and reporting activities
  • Responsible for evolution of Pharmacovigilance concepts and safety regulations and their effects on the business within the practices of Signal Management, and Safety Benefit and Risk Management
  • Develops an environment of continuous improvement within the team and contribute to continuous improvement initiatives across Safety
  • Provide oversight for establishing goals and best practices for these processes
  • Apply and mentor expert technical knowledge and best practices to all safety staff
  • Oversee and manage adequate input to contractual agreements with Business Partners and CROs regarding these practices where appropriate
Management of the safety teams:
  • Provides guidance on safety strategy to the teams and translates strategic imperatives into operational priorities and cascades through the group
  • Recruit and retain talented safety professionals. Provide coaching, mentoring, and development of staff
  • Ensure staff are compliant with Amgen corporate and departmental training
  • Disseminate relevant information to teams as appropriate
  • Contribute to Global Patient Safety goals development
  • Accountable for delivery against goals assigned to group
  • Participate in budget and headcount planning
  • Leads or sponsors significant cross-functional projects, initiatives, or training
Core Member in the Global Patient Safety Senior Management Team:
  • Represent GPS as decision maker as delegated by the Head of GPS in meetings with Amgen Sr. Management, Amgen review committees or governance boards, regulatory agencies and external partners. Provide timely safety input to Cross functional Leadership, senior management review committees, networks and governance boards
  • Ensures smooth and collaborative interactions with all other Safety groups
  • Provides relevant input on technical and processes in the department and contributes to continuous improvement initiatives across GPS
Inspection Readiness:
  • Undertake activities delegated by the EU QPPV as detailed in the PV System Master File and maintains a state of inspection readiness
  • Be representative and point of contact for Health Authority Inspections and Internal Process Audits within the remit of role and responsibility
Budget and resource management:
  • Prioritize and manage team budget and resources, including forecast, oversight and accountability for spend
  • Responsible for headcount management to confirm adequate support for PV activities
  • Manage and oversee outsourcing initiatives, activities and vendor
  • Performs other duties related to the position as necessary as defined in Standard Operating Procedures or as requested by his/her supervisor
What we expect of you
Basic Qualifications:
  • Doctorate Degree & 6 years of Safety Signal and Risk Management experience OR
  • Masters Degree & 10 years of Safety Signal and Risk Management experience OR
  • Bachelors Degree & 12 years of Safety Signal and Risk Management experience AND
  • 6 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
Preferred Qualifications:
  • Extensive knowledge of drug development, commercialization, and governance processes
  • Experience in Therapeutic Area Safety with accountability for safety activities for product(s)
  • Visionary strategic leadership abilities; ability to set the vision in alignment with the GPS vision, goals and objects
  • Demonstrated experience in critical thinking, leadership, communication, problem solving
  • Advanced understanding of international drug safety regulations
  • Knowledge of general medicine, clinical care, and principles of epidemiology, global PV and product safety processes
  • Understanding of supporting technologies, including safety databases and signal management and risk management technology
  • Demonstrated capability to manage global teams and multifunctional teams to the accomplishment of complex interdepartmental & international programs and projects
  • Advanced meeting facilitation skills to achieve consensus among diverse stakeholder groups
  • Aptitude for strategic thinking with the ability to identify root cause issues, apply subject matter knowledge to enable business improvement & minimize compliance risk
  • Knowledge of Pharmacovigilance processes and EU, FDA and international regulatory requirements as well as knowledge of Safety database structure and conventions, MedDRA and other dictionaries used in pharmacovigilance and methods of qualitative and quantitative safety data analysis
  • Collaborates with key stakeholders (e.g., VPs, customers, business leaders) and applies influence and negotiation skills to drive business results with ability to serve as a liaison to external contacts
What you can expect of us
As we work to develop treatments that take care of others, so we work to care for our teammates professional and personal growth and well-being.
  • Clear and disciplined strategic vision for the future that leverages superior-quality products, operational excellence and top-shelf-talent
  • Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
  • Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits
Amgens Commitment to Our Staff
At Amgen, our mission is serving patients. Our staff are dedicated to pushing the boundaries of science to transform medicine and turn the tide on serious illnesses. Central to achieving this mission is our people-first philosophy. We recruit the best talent, build an environment that facilitates career growth, and provide staff with the opportunity to make significant contributions for patients and our business.
Consistent with our core leadership value of Develops the Best Team, we are seeking leaders that prioritize the development of talent. As a manager, your priority and primary role is to accelerate the performance and development of your team. We expect managers to exemplify strong leadership and champion self-awareness and career development Ways that you will display your leadership acumen in this role include:
  • Mentoring, coaching, and developing staff to build highly-skilled, diverse, and inclusive teams
  • Fostering a positive and respectful work environment that encourages staff retention and motivates individuals to work toward common goals and priorities
  • Ensuring that staff understand how their efforts and contributions make a meaningful impact to the business
  • Growing core skills and capabilities among staff, particularly in learning agility, problem solving, strategic and creative thinking, flexibility, resilience, effective communication, prioritization, delivery of results, and continuous improvement
  • Making accurate evaluations of your team's skills and competencies and providing timely and respectful feedback, including direct delivery of difficult messages
  • Developing an understanding of your team's career objectives and serve as a thought-partner in their career development plans
  • Assisting staff with preparing for roles of growing responsibility and identifying new opportunities that expand their skills and align with their overall career objectives
  • Resolving critical gaps in the organizations internal capabilities and skillsets, including strategic external recruiting
  • Identifying diverse..... click apply for full job details