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.
Asset Lead Medical Director
Live
What you will do
Lets do this. Lets change the world. In this vital role you will be responsible for the development and implementation of US Medical strategies, including US launch and lifecycle management.
This role is responsible for:
- The development and execution of US product medical strategy, via the US Medical Plan, including launch support and lifecycle management, in collaboration with the Global Medical Leader, Product Team/Portfolio Governance and alignment with Global strategy
- Identification of scientific evidence gaps, development of US evidence generation strategy in coordination with the Global team
- Participating in engagement of external key stakeholders (often in partnership with other functions)
- Supports Medical input into label and regulatory interactions, in alignment and with deep understanding of global strategy and program clinical trial data
- Supports implementation of Medical governance for respective product, which includes:
- Safety and pharmacovigilance as a key and effective partner with GRAAS
- Clinical trial conduct
- US risk management/minimization in collaboration with GRAAS
- Subject matter appropriateness (medical/scientific) of external interactions (eg. Copy review, multichannel, congresses, 1-1 interactions, etc.)
- Ensuring appropriate medical support of compliance
Win
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a leader with these qualifications.
Basic Qualifications:
Doctorate degree and 4 years of relevant experience
OR
Masters degree and 7 years of relevant experience
OR
Bachelors degree and 9 years of relevant experience
Preferred Qualifications:
- Medical Degree
- 6 years of medical affairs or clinical development experience and education in relevant therapeutic area, 1+ years of which should be from a pharmaceutical or biotechnology company
- 4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
- Accredited fellowship in rheumatology or Allergy and Immunology (Board certified or board eligible)
- Demonstrated ability as a medical expert in rheumatological diseases in a complex matrix environment
- Pharmaceutical product development, product lifecycle and commercialization process knowledge with understanding of other functions; including, but not limited to, Clinical Operations, Commercial, Safety, Regulatory, Value & Access, and Medical Affairs
- Experience in regional/local medical practice and healthcare ecosystems
- Skilled at engagement, scientific exchange with external medical community
- Clinical research experience
- In-depth understanding of the scientific method and clinical applications based on medical, scientific and practical rationale
- Familiarity with concepts of clinical research and clinical trial design, including biostatistics
- Sound scientific and clinical judgment
- Knowledge of Good Clinical Practices (GCP), region regulations and guidelines, and applicable international regulatory requirements
- Familiarity of local pharmaceutical industry and legal/health system environment
- Finance/budgeting and resource management experience
- Proven ability to lead, manage, and motivate others in a complex, multi-functional, multi-national matrix environment
- Skilled at effectively presenting ideas and documenting complex medical/clinical concepts in both written and oral communication
- History of solving problems while exhibiting superior judgment and a balanced, realistic understanding of issues
- Network of medical, clinical contacts in product/therapeutic area
Thrive
What you can expect of us
As we work to develop treatments that take care of others, we also work to care for our teammates professional and personal growth and well-being.
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.
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
Apply now
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
Application deadline
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.
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.