Executive Medical Director, Global Development Lead

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

Live

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 clinical expert on the product, communicate the total evidence and biologic insights with internal stakeholders to align & inform their strategies, and with external stakeholders (KOLs / investigators, regulators, and payers) to shape the practice of medicine

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The candidate we seek is an experienced leader with the following qualifications.

Basic Qualifications

• MD or DO degree from an accredited medical school with extensive experience in similar role AND

• Five or more years of clinical development experience in industry and academic clinical research AND

• Managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources

Preferred Qualifications

• Accredited residency in Oncology, board certified or equivalent

• Eight (8) or more years of clinical research experience and/or basic science research combined with clinical teaching and patient care activities

• Clinical research experience in the biopharmaceutical industry (biotech, pharmaceutical or CRO company)

• Previous management experience

• Prior experience in clinical practice and /or development in medical Oncology

• Previous experience in regulatory interactions and filing activities for Oncology products

Knowledge and Competencies

• In-depth understanding of the scientific method and clinical applications based on medical, scientific and practical rationale

• In-depth understanding of and proven success in how to conceptualize, design, and conduct complex, global clinical trials

• Medical Knowledge in Oncology

• Understanding of regulatory agency organization, guidelines, and practices and ability to negotiate with these groups

• Knowledge of Good Clinical Practices (GCP), FDA regulations and guidelines, and applicable international regulatory requirements

• Understanding of new drug commercialization and business practices

• Understanding of resourcing and budgeting

• Proven ability to lead, manage, and motivate others in a complex, multi-functional matrix environment

• Ability to effectively present ideas and document complex medical/clinical concepts in both written and oral communication

• Demonstrated ability to organize and lead expert Clinical Research Advisory Panels

• History of solving problems while exhibiting superior judgment and a balanced, realistic understanding of issues

They will also embody the Amgen leadership attributes which are:

• Inspire: Create a connected, inclusive, and inspiring work environment that empowers talent to thrive

• Accelerate: Enable speed that matches the urgency of patient needs by encouraging progress over perfection

• Integrate: Connect the dots to amplify the collective power of Amgen to drive results for patients, staff, and shareholders

• Adapt: Lead through change by adapting to an ever-changing environment and defining a clear course of action to deliver results

Thrive

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.

The annual base salary range for this opportunity in the U.S. is $342,744 - $399,424.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of 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 that may include:

• 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

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 and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

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, disability status, or any other basis protected by applicable law.

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.

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.