Medical Director, Global Medical Affairs - Inflammation/Allergy (Open to Remote)

Company: Amgen Inc.
Location: Thousand Oaks
Posted on: June 6, 2021

Job Description:

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. Join us.

Medical Director, Global Medical Affairs - Inflammation/Allergy (Open to Remote)

Live

What you will do

Let's do this. Let's change the world. In this vital role you will support the Global Medical Lead and US Asset Lead in the development and execution of patient-focused medical strategies that maximize the value proposition of Amgen's therapies. These strategies will include annual strategic planning and goal setting, launch support and lifecycle management, and in collaboration with Global & US Medical Product Leads, appropriate cross-functional teams and governance. This role will have a special emphasis initially on US asthma launch, development of new LCM indications beyond asthma and support to US cross-functional team in execution of Amgen lead activities.

Key responsibilities will include:

• Contribute to cross functional stakeholder teams in shaping the healthcare ecosystem by enabling access to medicines through evidence generation, communication and education of medical and economic value
• Synthesize and integrate insights to deliver medical inputs into relevant cross regional/functional strategies, including relevant brand strategy
• Foster and enhance collaboration and coordination across Medical within Amgen and cross-company alliance collaboration
• Contribute to strategy development for scientific engagement across a broad range of stakeholders to strengthen external understanding of the unmet need and value of the product
• Lead/support relationships with external healthcare community, including interactions with opinion leaders, payers and societies for scientific exchange, where appropriate
• Develop/support and lead/support execution of the strategy for medical evidence generation that shapes our products and informs the practice of medicine ensuring key needs are met in alignment with global product medical and relevant brand strategy
• Foster Amgen's reputation as a science-based, innovative and patient-focused reliable partner
• Develop and/or contribute to execution of advocacy plans and strategies in partnership with internal stakeholders and lead relationships as appropriate
• Partner with/support Global Regulatory Affairs and Safety in risk management/minimization activities and ensure communication of the implications to internal/external stakeholders
• Member and Medical representative of relevant cross functional teams
• May develop and manage medical product budget
• Ensure conduct of medical activities in full compliance of all laws, regulations and SOPs
• Ensure product/disease state/pipeline specific medical training where appropriate, may deliver training to others
• Ensure appropriate clinical trial conduct as a key medical interface in close partnership with Global Development Operations (e.g. Site Management)
• Provide strategic input into labels/regulatory/reimbursement/policy/ promotional used to support internal/external interactions
• Determine scientific/medical subject matter appropriateness of labels/regulatory/reimbursement/policy/promotional and medical deliverables (e.g., slide decks, publications, educational activities) used to support internal/external interactions via appropriate review process
• Contribute to strategy development for, review, approve and ensure dissemination of, medical communications and related activities (e.g., product narrative, scientific platform, core content, publications, medical education and congresses)
• Provide support and leadership of advisory boards and other relevant meetings (e.g., investigator meetings, and/or expert panels)
• Lead/support the development of data interpretation, analysis and communication for medical executed studies
• Provide decision on IME, Donations, medical grants and sponsorships
• Utilize global infrastructure for tracking, measuring and evaluating performance and ensure continuous performance improvement
• Understand the expectations of key external stakeholders to support appropriate access to Amgen therapies
• In partnership with cross-functional team, ensure informed budget/resource trade-offs
• Facilitates Investigator Sponsored Studies through Amgen governance and manage study lifecycle (including communicating with investigators, as appropriate and ensuring accurate reporting of key milestone data)
• Contribute to lifecycle management plan

While this position is based in Thousand Oaks, California, the hiring manager is open to a remote work arrangement.

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The medical professional we seek is a leader with these qualifications.

Basic Requirements:

• MD or DO degree from an accredited medical school OR PharmD OR PhD
• AND a) 2 years of clinical, research or basic science research in pulmonary or allergy and immunology OR b) 2 years of medical affairs or clinical development experience in pharmaceutical industry

Preferred Skills:

• Doctor of Medicine (MD)
• Specialty in Pulmonary or Allergy and Immunology
• Demonstrated ability as a medical expert 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
• Scientific publication experience (developing manuscripts and/or congress abstracts)
• 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
• 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, 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

Apply now for a career that defies imagination

In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us. careers.amgen.com

Equal 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 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.

Keywords: Amgen Inc., Thousand Oaks , Medical Director, Global Medical Affairs - Inflammation/Allergy (Open to Remote), Other , Thousand Oaks, California