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Associate Medical Scientific Director
2 months ago
Associate Medical Scientific Director - Early Development
in
Washington D.C. ,
District Of Columbia
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.
Associate Medical Scientific Director - Early Development
Live
What you will do
Let’s do this. Let’s change the world. In this vital role you will contribute to early phase clinical development of oncology compounds from first-in-human studies through proof of concept. Collaborate on teams to support defining, design, and delivery of early phase clinical and translational projects. Through the role, the Associate Medical Scientific Director supports protocol development, study start up, data review and monitoring and analysis activities.
Responsibilities:
Support set up and execution of early phase clinical trials with a focus on data quality
Assist in authoring clinical protocols, Investigators Brochures and other regulatory documents ensuring consistency and clarity
Provide input into & implementation of data management plan, CRF design, and data review oversight
Support review, analysis, and presentation preparation of clinical trial data for internal decision making, external interactions, and regulatory submission
Assists Early Development Lead and Medical Sciences Director in medical monitoring and management of oncology phase 1 collaborators, consultants, and/or Clinical Research Organizations in completion of key projects
Anticipate and actively manage problems across a broad spectrum of cross-functional teams
Work cross functionally within teams to ensure clinical strategy is translated into the development of the study concept document, study protocol and related documents
Support appropriate training, recruitment, and development requirements for matrix team resources
Win
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a leader with these qualifications.
Basic Qualifications:
Doctorate degree and 3 years of clinical research experience
OR
Master’s degree and 5 years of clinical research experience
OR
Bachelor’s degree and 7 years of clinical research experience
OR
Associate’s degree and 12 years of clinical research experience
OR
High school diploma / GED and 14 years of clinical research experience
Preferred Qualifications:
3 years of pharmaceutical clinical drug development experience.
Industry or academic experience in early-phase oncology drug development
Extensive experience monitoring, cleaning, reviewing clinical trial data and developing medical data review plans.
Experience serving on cross functional team and demonstrated ability to collaborate with clin ops though the conduct of a study
Experience in clinical data analysis such as Spotfire or other data analysis tools
Experience in writing oncology phase 1 clinical protocols
Experience in contributing to key regulatory documents including IND, IB, DSUR
Experience in study start up and close out
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 expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.
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 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.
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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