Medical Sciences Director - Early Development Oncology

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 Sciences Director - Early Development

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. They will collaborate on teams to define, design, and deliver early phase clinical and translational projects as the initial strategy for drug development. Through their role, the Medical Sciences Director provides subject matter expertise in data review and analysis.

• Assist with set up and execution of early phase clinical trials with a focus on data quality
• Responsible for providing input into & implementation of data management plan, CRF design, and data review oversight
• Accountable for review, analysis, and presentation of clinical trial data for internal decision making, external interactions, and regulatory submission
• Assists Early Development Lead 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

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.

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

• 5 years of pharmaceutical clinical drug development experience
• Strong preference for individuals with proven track record of oncology clinical trial process improvement
• Industry or academic experience in early-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

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

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

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.