Executive Medical Director, Global Safety TA Head- Oncology

Thousand Oaks, CA, US
Nov 10, 2020
Required Education
Masters Degree/MBA
Position Type
Full time
The Global Safety Therapeutic Area Heads serve as the safety specialists for all Amgen products globally and are accountable for the safety strategy and major safety deliverables for each Amgen product.

The Executive Medical Director Global Safety, Therapeutic Area Head of Oncology reports into the VP of Global Patient Safety & Pediatrics and serves 3 roles:
  • Safety specialist in Oncology and is accountable for the safety strategy and safety deliverables
  • Leader of the Oncology Safety Teams and is accountable for the staff management and resource planning/allocation
  • A core member of GPS SLT committee to support The GPS VP in the establishment of a highly effective global safety organization in full compliance with worldwide regulations

Key Responsibilities:
  • Serve as Safety specialist in Oncology
  • Accountable for providing strategic oversight and direction for all regulatory safety responses or strategic deliverables including but not exclusive to Safety sections of NDA submissions, RMPs, PSURs, PBRERs, DSURs, DILs
  • Leads the safety strategy and Benefit/Risk Management Process for assigned portfolio and ensures TA Staff provides ongoing monitoring of safety profiles for Amgen products worldwide
  • Chairs and participates in safety governance meetings per Standard Operating Procedures and Manuals
  • Oversee Oncology Safety input to contractual agreements with Business Partners and CROs
  • Works cross-functionally with Development and Regulatory TA Heads to reach issue resolution
  • Provide safety oversight, strategy and guidance to therapeutic areas and other groups within Clinical Development, Medical Affairs, Regulatory and the commercial organizations
  • Management of the Oncology safety teams providing direction and allowing appropriate prioritization of resources to achieve goals
  • Recruit and retain hardworking safety professionals and provide coaching, mentoring, and development of staff
  • Ensure staff are aligned with Amgen corporate and departmental training
  • Contribute to Global Patient Safety goals in development
  • Participate in budget and headcount planning
  • Lead or sponsor cross-functional projects, initiatives or training
  • Be accountable for Inspection Readiness
  • Be representative and point of contact for Health Authority Inspection and Internal Process Audits within the remit of role and responsibility

Basic Qualifications:
  • MD or DO degree from an accredited medical school with 6 years of directly related experience AND
  • Clinical experience in either an accredited academic setting or private practice (including hospital based) setting 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:
  • 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
  • Previous product safety experience and knowledge of clinical trials and drug development
  • Knowledge of Oncology patient populations and drug classes
  • History of effective leadership with a matrix organization
  • Issue and crisis management
  • Forward-thinking strategic leadership abilities and capability to handle global teams and multi-functional teams to the accomplishment of sophisticated 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

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 first 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 acuity 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 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

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 contributions for patients and our business.

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.