Executive Medical Director, Global Development Lead

Career Category

Clinical Development

Job Description

JOIN AMGEN’S MISSION OF SERVING PATIENTS

At 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.

Executive Medical Director, Global Development Lead

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What you will do

Let’s do this. Let’s change the world. In this vital role as the Global Development Lead (GDL), you will have the opportunity to contribute to the development of global product strategy, lead global development strategy from Phase 2 and beyond and lead the design and implementation of the Total Evidence Generation Plan (EGP), through the effective leadership of the Evidence Generation Team (EGT) for the AMG 193 program.

Responsibilities

• Provide deep medical insights in disease biology, product attributes, and clinical trial design into the development of Product Team strategic options and Global Product Strategy

• As a core member of the Product Team, contribute to the Global Product Strategy and represent the unified, cross-functional EGT voice in program strategic options

• Lead the EGT in the development and implementation of the total evidence generation package for the asset (e.g., registrational, non-registrational, real world evidence)

• Define product profile through design, execution, and interpretation of clinical evidence

• Collaborate cross functionally and cross regionally to ensure that the EGS and EGP balances multiple stakeholder needs with product attributes and delivers globally relevant data throughout the product lifecycle

• Lead development of study documents (e.g., Study Outlines, Protocols, RACT, DMP) for global clinical studies, including Phase 1B and Phase 3 registrational studies

• Partner with regulatory to lead registrational activities, including regulatory interactions, development of documents for regulatory submission and discussion, and filing activities

• Partner with Global Development Operations and local organizations (DOMs/Country Medical Directors) to ensure timely delivery of high quality global clinical data

• Support the Global Medical team in capturing and translating local / regional data gaps into actionable EGPs, in alignment with global product strategy and global EGP

• Partner with GRAAS/ GV&A to define and maintain product benefit/risk profile and facilitate global registration and reimbursement

• Provide medical / scientific leadership and input into:

  • Key regulatory/safety deliverables (e.g., core labeling and global regulatory submission documents, periodic safety update reports)

  • Regulatory responses; Represent all clinical and development aspects during regulatory authority meetings (e.g., advisory committee meetings, label negotiations)

  • Health authority queries and benefit/risk assessments throughout the product lifecycle

  • Global Value Dossier, HTAs and payer negotiations

• Partner with Global Medical organization and contribute to:

  • Global evidence communication through development of Global Publication Plans

  • Global Core Content (e.g., disease state, clinical trial letters) creation

  • Share total evidence and biologic insights with internal stakeholders to inform their strategies/deliverables; external stakeholders to seek expert advice to inform development strategies

• Manage relationships with alliance partners to ensure alignment and execute on development strategy and evidence generation plans

• Provide strategic medical input into Licensing and Business Development strategies

• Manage a high performing Evidence Generation Team and develop staff

• Mentor, coach, and oversee the performance of direct reports, provide input into performance of EGT members

• As the cl