• Job Description

  Req#: R-183015

  Career Category

  Clinical Development

  Job Description

  HOW MIGHT YOU DEFY IMAGINATION?

  At Amgen, every challenge is an opportunity. And every opportunity brings the potential to change lives. Our shared mission—to serve patients—has driven our status as one of the world’s preeminent biotechnology companies, reaching over 10 million patients worldwide. Leverage your high-level expertise to lead and forge partnerships that advance the biotechnical and biopharmaceutical science that can turn the tide of serious, life-interrupting illnesses.

  Executive Director, Global Development Lead- Tavneos

  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). This will be led through the effective leadership of the Evidence Generation Team (EGT) for the Tavneos 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 stakeholders 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 (Global Regulatory Affairs Strategy) 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 Executive Director we seek is an experienced leader with the following qualifications. 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

  Basic Qualifications:

  • MD or DO degree from an accredited medical school AND

  • Five years of industry or academic research AND

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

  Preferred Qualifications:

  • MD plus accredited residency Immunology/Rheumatology 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 within auto immune diseases (biotech, pharmaceutical or CRO company)

  • Previous management experience

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

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

  • 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

  • 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

  Thrive

  What you can expect of us

  As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.

  The annual base salary range for this opportunity in the U.S. is $325,999 - $381,560.

  In addition to the base salary, Amgen offers a Total Rewards Plan comprising 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 including:

  • 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

  Amgen’s Commitment to Our Staff

  At Amgen, our mission is serving patients. Our staff are dedicated to pushing the boundaries of science to transform medicine and turn the tide on serious illnesses. Central to achieving this mission is our “people-first” philosophy. We recruit the best talent, build an environment that facilitates career growth, and provide staff with the opportunity to make significant contributions for patients and our business.

  We equip all our staff members to live well-rounded, healthy lives. Most recently, Amgen added benefits for transgender employees and continues to pride itself on industry-leading, family-friendly offerings for families of all compositions.

  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 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.

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  Salary Range

  325,299.00 USD - 381,560.00 USD

• About the company

  Amgen is one of the world’s leading biotechnology companies. Amgen is a values-based company, deeply rooted in science and innovation to transform new ideas and discoveries into medicines for patients with serious illnesses.

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