Job Abstract

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- Xaluritamig

Live

What you will do

Amgen Oncology: for every patient, a solution.

We aim to deliver novel therapies to improve the lives of patients living with cancer.    Utilizing our innovative technology platforms – Bispecific T Cell Engagers (BiTE®s), Complex Biologics, Small Molecules, and Antibody Drug Conjugates – we are addressing cancer broadly through novel target discovery and therapeutic approaches.

We are seeking an experienced, ambitious, and collaborative clinical leader to be the Global Development Lead (GDL) of xaluritamig, a novel STEAP1 targeted T-cell engager being developed for prostate cancer.   In this role, you will work cross functionally to lead the trial designs, study oversight and data interpretation of the clinical research studies.  This individual will oversee a team of clinical development professionals and report to the VP of Global Development Oncology.

Responsibilities Include:

• Provide medical and strategic insight by directing the clinical trial design, strategy execution and data analysis in accordance with Good Clinical Practice and regulatory guidelines to support advancement of the program.    

• Serve as a liaison between the company, clinical investigators, and KOLs to communicate scientific and clinical findings to drive collaboration and advance novel scientific strategies.

• Lead, build and mentor the clinical development team to support the overall resourcing needs of the program

• Lead or provide oversight for development of study documents (e.g., Study Outlines, Protocols, RACT, DMP) for global clinical studies

• Serve as the clinical leader and core member of the Product Team to ensure that the clinical and scientific strategies are aligned with the overall Product Team strategy

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

• Partner with the clinical operations team to ensure timely delivery of high quality global clinical data

• 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 regulatory submissions and responses as well as:

  • 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

• Provide strategic medical input into Licensing and Business Development opportunities

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

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

• Understanding of new drug commercialization and business practices

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

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

Win

What we expect of you

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

Basic Qualifications

• MD or DO degree from an accredited medical school AND

• Five (5) years of industry or academic research AND

• Six (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 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

• Five (5) or more years of clinical development experience in industry and/or academic clinical research with in-depth understanding and experience in study conceptualization, protocol writing, trial conduct and reporting

• Prior experience in clinical practice and /or development in GU (genitourinary; preferably Prostate cancer) Oncology

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

• Outstanding oral and written communication with an ability to present complicated clinical and scientific findings and support collaboration both internally and externally.

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

• Medical Knowledge and experience in prostate or genitourinary oncology

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

• Understanding of resourcing and budgeting

• Ability to effectively present ideas and document 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

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 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.

Salary Range