Medical Sciences Director- Late Development Oncology, Prostate

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.

Medical Scientist Director Late Development Oncology

Live

What you will do

Lets do this. Lets change the world. In this vital role you will contribute to late phase clinical development of oncology. They will collaborate on teams to define, design, and deliver late phase clinical results, supplemented by translational projects in the ongoing strategy for drug development. Through their role, the Medical Director provides subject matter expertise in clinical and translational trial science as well as the biology and treatment of cancer. They will contribute intellectual insight into experimental design and data analysis.

  • Serve as an internal clinical expert in translational and clinical oncology

  • Support medical monitor in clinical trials and assist in resolving issues that may arise

  • Present information internally and externally, anticipating and actively managing problems across a broad spectrum of cross-functional teams

  • Provide guidance and assistance in the identification and management of oncology collaborators, consultants, and/or Clinical Research Organizations (CROs) in completion of key projects

  • Work cross functionally to ensure clinical strategy is translated into the development of the study concept document, study protocol and related documents.

  • Ensure integrity of protocols and/or components of clinical plans and for the delivery of final protocol and its governance approval.

  • Provide clinical input into & implementation of clinical trial(s), their delivery, clinical data review, interpretation of results. Review and analyze clinical trial data to ensure accuracy, completeness and adherence to protocol and regulatory requirements

  • Conduct thorough data quality assessments in the context of a data monitoring plan to maintain high standards of data accuracy and integrity throughout the trial lifecycle

    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 4 years of medical science experience
    OR
    Masters degree and 7 years of medical science experience
    OR
    Bachelors degree and 9 years of medical science experience

    Preferred Qualifications:

  • 5 years of pharmaceutical clinical drug development experience

Strong preference for individuals with consistent track record of oncology clinical trial process improvement

Industry or academic experience in late-phase oncology drug development

Strong communication & presentation skills to clearly communicate scientific concepts /data to leadership committees both internally or externally (both written and oral)

Experience with designing, monitoring, and implementing oncology clinical trials and interpreting test results in compliance with Good Clinical Practice standards and regulatory requirements

Understanding of conducting study data readout activities, including data cleaning, data base lock, data extract, producing outputs of data

Experience drafting high level submission documents for regulatory submissions including authoring clinical regulatory responses for health regulatory interactions

Serving as a contributing author to scientific publications and data presentations at scientific conferences

Experience in clinical data analysis such as Spotfire or other data analysis tools

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 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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