Global Platform Medical Director
Vor 5 Tagen
**HOW MIGHT YOU DEFY IMAGINATION?**:
You’ve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge you’ve worked hard to acquire and the passion you already have. 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, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.
**Global Platform Medical Director - Inflammation**
**Live**:
**What you will do**
Let’s do this. Let’s change the world. Reporting to the Global Medical Affairs Inflammation Platform Lead, the Global Platform Medical Director will be responsible for supporting the Medical strategy programs and priorities in Inflammation across ex-US markets.
**Key Activities**:
- Support platform-specific ex-US market Medical strategies, programs and activities (e.g. launch readiness, pipeline, clinical and LCM, data dissemination, top-tier global OL engagement);
- Shape strategies to develop and disseminate Medical information that support appropriate use of Amgen products globally, including ensuring compliant delivery of information and partnering with GRAAS and affiliates to support regulatory and compliance needs requiring global attention;
- Lead the execution of the inflammation pipeline medical affairs activities for assets not currently supported by a Global Medical Affairs Lead.
**Responsibilities**:
Support prioritized platform-specific ex-US needs with ongoing Medical activities and coordination of resources
- Provide feedback & support clinical programs (e.g. CDP, key evidence generation); support development with pipeline trial execution
- Engage top-tier global OLs on Medical topics and sci. discourse (e.g. Prolia fracture details, BiTEs) to ensure appropriate patient outcomes
- Coordinate, prioritize, and manage communication/requests from Global cross-functions to affiliates and from affiliates to global
- Partner with markets and GRAAS to support regulatory and compliance issues which may require global attention
Support execution of programs and integrate Medical input globally
- Connect platform-level in-market medical issues or questions with Global capability clusters
- Support shaping of healthcare ecosystem to ensure positive patient outcomes and implement Globally-led disease state education
- Support launch readiness, LCM and evidence generation
- Partner with MSL teams on integrating strategic insights to deliver Medical inputs into relevant cross-functional platform strategies
Overall:
- Contribute to Amgen's Safety and Benefit/Risk profile of a molecule and ensure communication of the implications to external stakeholder, Support Investigator Sponsored Studies (ISS), and approve competitive grants, if applicable
- Provide strategic direction for study design and execution for medical affairs studies
- Enable access to medicines through clear understanding and education of treatment value in partnership with cross-functional stakeholders
- Facilitate and continue to build Amgen’s role as a science-based, patient-focused partner
**Win**
**What we expect of you**
We are all different, yet we all use our unique contributions to serve patients.
**Basic Qualifications**:
- MD/DO degree from an accredited medical school or PhD/PharmD AND
- 5 or more years of medical affairs experiences and/or clinical research experience and/or basic science research in Rheumatology or Dermatology or related medical discipline
**Preferred Qualifications**:
- MD plus accredited fellowship in Rheumatology or Dermatology or related medical discipline, board certified or board eligible
- PhD/PharmD will be considered based on individuals’ profile
- 10 + years Medical Affairs experience in the biopharmaceutical industry (biotech, pharmaceutical or CRO)
- Experience with pipeline assets, launches or supporting mature brands
- Regional experience, overseeing affiliates within a TA
- Clinical and disease knowledge base in Inflammatory diseases, including rheumatology, dermatology and gastroenterology
- Experience with stakeholder engagement and interactions (e.g., OLs, advocacy groups, payers)
- 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
- Track record of success working with matrixed cross-functional teams
**Thrive**:
**Some of the vast rewards of working here**
As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal gro
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