Head of Therapeutic Area Safety

Company: Amgen Inc. (IR)
Location: Thousand Oaks
Posted on: February 9, 2025

Job Description:

Head of Therapeutic Area Safety page is loadedHead of Therapeutic Area SafetyApply remote type Remote locations US - California - Thousand Oaks time type Full time posted on Posted 4 Days Ago job requisition id R-205457Career CategorySafetyJob DescriptionHOW MIGHT YOU DEFY IMAGINATION?At Amgen, every challenge is an opportunity. And every opportunity brings the potential to change lives. Our shared mission-to serve patients-has driven our status as one of the world's 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.Head of Therapeutic Area SafetyLiveWhat you will doLet's do this. Let's change the world. The Head of Therapeutic Area Safety (TAS) is a pivotal global leadership role where you will be responsible for driving innovation, strategic vision, and transformational initiatives for TAS within the Global Patient Safety (GPS) organization. You will have end-to-end accountability for safety across the therapeutic areas of Oncology, Rare Diseases, General Medicine, Obesity, and Inflammation, spanning the product lifecycle from development through post-marketing. You will provide strategic direction, foster integration with cross-functional stakeholders, and prioritize resource allocation to enable alignment with organizational objectives while ensuring compliance.You will serve as a core member of GPS Leadership team and will support the GPS Vice President (VP) in the establishment of a highly effective global safety organization in full compliance with worldwide regulations. This role reports into the Head of Global Patient Safety.Responsibilities:Global Strategic Leadership of Therapeutic Area Safety:

• Develop and execute a forward-thinking, innovative strategy for the TAS function aligned with organizational goals and regulatory requirements.
• Lead a team of global safety experts across designated therapeutic areas, ensuring benefit-risk optimization, effective risk management, and proactive safety communication.
• Drive the integration of cutting-edge safety science, digital health solutions, and data analytics to advance safety practices and decision-making.
• Collaborate with Head of Safety to contribute to corporate Portfolio Governance decision making.Oversight of Therapeutic Area Safety Teams:
  • Oversee Therapeutic Area Heads enabling safety strategic oversight and prioritization.
  • Establish and prioritize goals for therapeutic area safety teams to achieve key milestones with effective resource capacity planning.
  • Lead the Therapeutic Area Safety Strategic Committee to ensure consistent application of best practices and continuous improvement initiatives across all therapeutic areas.
  • Serve as delegate for Head of Safety in governance and committee meetings as needed.Cross-Functional Integration and Leadership:
    • Collaborate with senior leadership in GPS, Clinical Development, Medical Affairs, Regulatory, Digital Health, Operations, Commercial, Value and Access, and other functions to align safety strategy with business objectives.
    • Serve as a key safety representative in high-level discussions, fostering a culture of safety excellence and innovation across the organization.Transformation and Innovation:
      • Drive transformation initiatives within TAS by leveraging new technologies, AI-driven insights, and evolving safety methodologies.
      • Promote a culture of innovation by championing continuous learning, cross-functional collaboration, and proactive risk assessment.
      • Monitor global safety trends and adapt strategies to ensure alignment with industry advancements and regulatory expectations.Talent Management and Development:
        • Recruit, retain, and develop a diverse and talented team of safety professionals.
        • Provide coaching, mentoring, and professional development opportunities to staff, fostering a high-performance and collaborative culture.
        • Act as a role model for leadership, promoting inclusion, accountability, innovation and strategic thinking within the TAS organization.Why Join Us?
          • Be at the forefront of shaping the future of therapeutic area safety, driving transformative initiatives that impact patient lives globally.
          • Collaborate with top-tier professionals across disciplines to achieve a shared vision of innovation and excellence.
          • Opportunity to lead in a dynamic and evolving environment, where your strategic insights and leadership will make a lasting impact.What we expect of youWe are all different, yet we all use our unique contributions to serve patients. The Head of TAS we seek is an experienced leader with the following qualifications.Basic Qualifications:
            • MD or DO degree from an accredited medical school AND
            • Five (5) years of industry or academic research AND
            • Six (6) years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources.Preferred Qualifications:
              • Experiences within pharmacovigilance, regulatory science, and therapeutic area expertise.
              • PhD with 15 years of directly related experience.
              • Clinical experience in either an accredited academic setting or private practice (including hospital based) setting.
              • Previous product safety experience and knowledge of clinical trials and drug development.
              • Knowledge of patient populations and drug classes.
              • Issue and crisis management.
              • Strategic vision and leadership ability, capable to manage global teams and multifunctional teams to the accomplishment of complex interdepartmental & international programs and projects.
              • Understanding of international drug safety regulations, global pharmacovigilance and product safety processes.
              • Knowledge of general medicine, clinical care, and principles of epidemiology.
              • Influencing skills with capability to present strategies, policy & work processes to diverse audiences, geographies, departments, and organization levels.
              • 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 organization's internal capabilities and skillsets, including strategic external recruiting.
              • Identifying diverse, qualified successors for key positions.
              • Ensuring that direct reports who also lead people consistently demonstrate these same behaviors with their staff.Amgen's Commitment to Our StaffAt 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.We equip all our staff members to live well-rounded, healthy lives. Most recently, Amgen added benefits for transgender employees and continues to pride itself on industry-leading, family-friendly offerings for families of all compositions.Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.Salary RangeThe annual base salary range for this opportunity in the U.S. is $352,570 - $430,918.In addition to the base salary, Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:
                • 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 and bi-annual company-wide shutdowns.
                • Flexible work models, including remote work arrangements, where possible.About UsAmgen 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 biologics manufacturing 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.
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Keywords: Amgen Inc. (IR), Thousand Oaks , Head of Therapeutic Area Safety, Other , Thousand Oaks, California