Description
**HOW MIGHT YOU DEFY IMAGINATION?**
If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of.
**Medical Director, Early Development**
**Live**
**What you will do**
Let’s do this. Let’s change the world. Amgen is advancing the largest early Oncology pipeline in our history spanning several innovative technology platforms – Bispecific T Cell Engagers (BiTE®s), Cellular Therapies, Bispecific Antibodies, Small Molecules, and Oncolytic Viruses – across many targets and more than a dozen tumor types. We need collaborative and innovative world-class talent to ensure these molecules become medicines and reach their full potential while helping patients.
To support that effort, the Oncology Early Development Group is looking for a Medical Director. The Medical Director will lead early phase clinical development of oncology compounds from first-in-human studies through proof of concept. They define, design, and execute early phase clinical and translational projects as the initial strategy for drug development. They typically serve as clinical project leaders for one or more of Amgen’s Product Strategy Teams through their role as an Early Development Leader (EDL).
These experts represent Medical Sciences/Early Development internally and externally, contributing intellectual insight into experimental design and data analysis. They provide subject matter expertise in clinical and translational trial science as well as the biology and treatment of cancer.
Responsibilities:
Serve as an internal clinical expert in translational and clinical oncology.
Serve as medical monitor for clinical trials and assist in resolving major issues that may affect the studies.
Present information internally and externally, anticipating and proactively managing problems across a broad spectrum of cross-functional teams.
Coordinate clinical approaches to operational issues and assign monitoring and safety reporting resources.
Provide guidance and assistance in the identification and management of oncology phase 1 collaborators, consultants, and/or Clinical Research Organizations (CROs) in the completion of key projects.
Ensure appropriate training, recruitment, and development requirements for matrix team resources.
Will be the primary Medical Sciences contact for basic scientists studying hematologic and solid tumor malignancies as well as for clinical research scientists overseeing later clinical development.
Evaluate external opportunities for partnering or licensing new oncology assets
**Win**
**What we expect of you**
We are all different, yet we all use our unique contributions to serve patients. The medical professional we seek is a leader with these qualifications.
**Basic Qualifications:**
MD or DO degree from an accredited medical school
AND
2 years of clinical research experience and/or basic science research
**Preferred Qualifications**
+ Subspecialty board eligibility/certification in Oncology/Hematology.
+ Strong basic science or clinical research background in academia or industry
+ Prior experience authoring, monitoring, analyzing, and presenting oncology clinical trials
+ Effective presentation and communication abilities (both written and oral)
+ Ability to anticipate problems and find creative solutions
+ In-depth understanding of the scientific method and clinical applications based on medical, scientific, and practical rationale including working knowledge of biomarker methods and clinical imaging endpoints
+ A record of high-quality peer-reviewed publications
+ Experience functioning as a medical expert in a complex matrixed environment
+ Previous experience in early phase development and/or biomarker work
+ Previous experience in late-stage oncology clinical trials and regulatory filings
+ Demonstrated expertise in conducting translational and/or clinical oncology research
+ Expertise in Spotfire or other data analysis tools
+ Knowledge of GCP, EMA, and FDA policies
+ Expertise in authoring clinical sections of CTA or INDs
**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.
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
**Apply now**
**for a career that defies imagination**
Objects in your future are closer than they appear. Join us.
**careers.amgen.com**
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.
