Clinical Development, Senior Medical Director- Rheumatology
Job title: Clinical Development, Senior Medical Director- Rheumatology in USA at Amgen
Company: Amgen
Job description: Career Category Clinical DevelopmentJob DescriptionJoin Amgen’s Mission of Serving PatientsAt Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.Clinical Research Senior Medical DirectorWhat you will doLet’s do this. Let’s change the world. In this vital role you will serve as clinical expert to provide clinical/scientific knowledge into the development, delivery and communication of the global scientific/medical evidence plan for the CD19 assets in Inflammation program indication(s). Additional responsibilities include:
Expected salary:
Location: USA
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Company: Amgen
Job description: Career Category Clinical DevelopmentJob DescriptionJoin Amgen’s Mission of Serving PatientsAt Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.Clinical Research Senior Medical DirectorWhat you will doLet’s do this. Let’s change the world. In this vital role you will serve as clinical expert to provide clinical/scientific knowledge into the development, delivery and communication of the global scientific/medical evidence plan for the CD19 assets in Inflammation program indication(s). Additional responsibilities include:
- Provide medical leadership for clinical trial(s) and develop and implement strategies to drive patient enrollment in partnership with clinical operations and medical affairs organizations.
- Provide oversight of Patient Impact Expansion (PIE) clinical development with input on global strategy
- Support cross-functional and global collaborations to integrate broad medical, regulatory, safety, scientific, and commercial access and value input into the development program(s)
- Participate and provide clinical input into safety and regulatory interactions.
- Interpret and communicate clinical trial data.
- Author/review CSRs, publications and regulatory submissions
- Develop key opinion leaders and make scientific presentation at advisory boards, key
- scientific meetings and external committee meetings as delegated by GDL
- Identify new clinical research opportunities.
- Support in-licensing and out-licensing activities and partner relationships Support Patient Impact Expansion (PIE) for new indications as directed by Global Development Lead
- Provide clinical content input to materials to be used in Scientific Affairs as well as the Commercial Organization
- Approximate 10% travel may be required.
- MD plus accredited residency and fellowship training in rheumatology, board certified or equivalent. Five (5) or more years of clinical development experience and/or basic science research combined with clinical teaching and patient care activities.
- Clinical development experience in the biopharmaceutical industry (biotech, pharmaceutical or CRO company)
- Experience in development lifecycle management to include development strategy creation for large programs from early development, through late development and commercialization.
- Involved in filing activities as part of the moving the program through the development lifecycle.
- Key relationship development and collaboration with the expansive commercial and medical teams internal and external partners and key opinion leaders.
- Previous management experience of clinical development professionals
- A 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
- Flexible work models, including remote and hybrid work arrangements, where possible
Expected salary:
Location: USA
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