Associate Medical Scientific Director

2 months ago

Washington DC, United States Amgen Full time

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of.

Associate Medical Scientific Director - Early DevelopmentLive

What you will do

Lets do this. Lets 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 resourcesWin

    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

    Masters degree and 5 years of clinical research experience

    OR

    Bachelors degree and 7 years of clinical research experience

    OR

    Associates 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 developmentExtensive 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 studyExperience in clinical data analysis such as Spotfire or other data analysis toolsExperience in writing oncology phase 1 clinical protocolsExperience in contributing to key regulatory documents including IND, IB, DSURExperience in study start up and close outThrive

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 planStock-based long-term incentivesAward-winning time-off plans and bi-annual company-wide shutdownsFlexible work models, including remote work arrangements, where possibleApply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.careers.amgen.comApplication deadline

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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