Strategic Planning & Operations Director
HOW MIGHT YOU DEFY IMAGINATION?
If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of. Join us.
Strategic Planning & Operations Director - Clinical Evaluation LeadLive
What you will do
Lets do this. Lets change the world. In this vital role of Strategic Planning and Operations Director - Clinical Evaluation Lead, you will build, optimize and manage the process for medical device clinical evaluations, including developing evaluation strategies, clinical evaluation plans, and periodic clinical evaluation reports across programs. The Clinical Evaluation Lead will report to the Executive Director, R&D Strategy and Operations.
The Clinical Evaluation lead will liaise with subject matter experts across functions, and with Notified bodies, National Competent Authorities and Expert Panels. The Lead will manage stakeholders by clearly communicating status, issues, implications and recommendations, and be accountable for producing premarket and post market strategy documents, plans and reports.
- Work with Cross Functional Experts and Leaders to stand up a Clinical Evaluation process supporting capabilities including Risk Management, Performance Management, Continuous Improvement, among other things.
- Coordinate the development of clinical development strategies, risk assessments, and authoring and maintenance of Clinical Evaluation Plans and reports
- Monitor and manage any remediation with all internal and external stakeholders
- Ensure Clinical Evaluation process success, by managing risks, removing roadblocks, driving innovative thinking, maintaining fair process, escalating issues and delivering high quality results.
- Serve as an integrator across multiple stakeholders and functions.
- Partner with Quality and Compliance organizations for inspection preparedness to ensure successful audit outcome
- Build and maintain strong relationships with stakeholders; proactively communicating, seeking advice, and facilitating critical business decisions.
- Adapt to a rapidly changing, fast-moving and often ambiguous environment.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The professional we seek is an agile crossfunctional leader with these qualifications.
- Doctorate degree and 4 years of Scientific and/or Operations and/or Regulatory experience OR
- Masters degree and 7 years of Scientific and/or Operations and/or Regulatory experience OR
- Bachelors degree and 9 years of Scientific and/or Operations and/or Regulatory experience
- 10+ years experience in applied regulatory matters, including implementing and operatizing regulations and direct communication with regulatory agencies
- Knowledge of EU device regulatory matters
- Clinical Investigation experience
- Risk Management and/or post market surveillance and/or device vigilance experience
- Design Control experience
- Excellent oral and written communication skills, including ability to storyline and prepare executive-level discussion documents
- Excellent conceptual problem-solving skills with demonstrated ability to bring structure to vaguely defined problems, pragmatically scope problem solving approach, and manage execution
- Strong quantitative and qualitative analytic skills
- Strong leadership skills with a demonstrated ability to influence different styles
- Strong written/oral communication skills and executive presence across functions and across different levels of leadership
- Drug Development knowledge with basic to strong understanding of activities within Research, Preclinical and Clinical Development, Medical and Regulatory
- Independent, motivated team member with experience in a matrix environment
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.
- Vast opportunities to learn and move up and across our global organization
- 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
In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.
careers.amgen.comEqual Opportunity Statement
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 a 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 an accommodation.
Join UsIf 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.