Medical Director, Rare Disease Pipeline
1 month ago
HOW MIGHT YOU DEFY IMAGINATION?
If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of.
Medical Director, Rare Disease Pipeline
Live
What you will do
Let’s do this. Let’s change the world. In this vital role you will be accountable for the development and execution of global medical affairs strategy for Uplizna
Contribute to the development and execution of the global medical affairs strategy for multiple rare disease pipeline assets
Serve as the Medical Affairs Representative on various global strategic teams.
Support the development of the integrated evidence generation plan for developing rare disease pipeline assets.
Capture clinical/scientific insights across all key markets and translate them into concrete strategies.
Facilitate scientific engagements across a broad range of partners (e.g. KOLs, Professional Organizations, Payers, Regulators)
Align and implement strategy for medical communications and related activities.
Develop medical strategic plans and ensure consistent execution of outputs through Medical Affairs Teams.
Provide strategic direction for study design and execution for medical affairs and other global studies.
Enable access to medicines through clear understanding and education of treatment value.
Facilitate and continue to build Amgen’s role as a science-based, patient-focused partner.
Provide input to Value Dossiers.
Determine resource and budget allocation necessary to deliver on medical strategies.
Cultivate and improve collaboration and coordination across medical functions.
Lead/support relationships with the external healthcare community.
Serve as a medical representative in leadership, governance, and cross-functional teams.
Provide insights to Amgen's Safety and Benefit/Risk profile of the molecule.
Support evidence generation that shapes the therapeutic area and informs the practice of medicine.
Synthesize and integrate insights to deliver medical inputs into cross-regional/functional strategies.
Review, approve, and ensure dissemination of medical communications and related activities.
Lead or support advisory boards and other meetings.
Ensure conduct of medical activities in full compliance with all laws, regulations, and SOPs.
Use global infrastructure for tracking, measuring, and evaluating performance and ensuring continuous performance improvement.
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 medical affairs or clinical development experience in rare disease, internal medicine, inflammation, and/or neurologic indications
OR
Master’s degree and 8 years of medical affairs or clinical development experience in rare disease, internal medicine, inflammation, and/or neurologic indications
OR
Bachelor’s degree and 10 years of medical affairs or clinical development experience in rare disease, internal medicine, inflammation, and/or neurologic indications
In addition to meeting at least one of the above requirements, you must have at least 4 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above
Preferred Qualifications:
3 years of clinical research and/or medical affairs experience in a leadership role
Clinical experience and disease knowledge base in internal medicine, pediatric, rare disease, inflammation, and/or neurologic indications.
MD plus accredited fellowship in medical/surgical sub-specialty and/or neurologic indications
Minimum of 5 years of Medical Affairs experience in industry (biotech, pharmaceutical or CRO)
Experience in building Integrated Evidence Generation Plans
Ability to establish interactions and engagements with partners (e.g., Opinion Leaders, advocacy groups, patients, payers, vendors)
Familiarity with global regulatory organizations, guidelines, and practices
Knowledge of Good Clinical Practices (GCP) and global regulations and guidelines
Knowledge of pharmaceutical product development, product lifecycle, and commercialization processes, including but not limited to, clinical operations, commercial, regulatory, and medical affairs
History of solving problems while exhibiting sound scientific/medical judgment and a balanced, realistic understanding of issues
Good understanding of healthcare systems around the world (e.g. US, EU, Asia)
Track record of success working with matrixed cross-functional teams
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.
careers.amgen.com
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.
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