Medical Sciences Director - Early Development Oncology

Career Category

Clinical Development

Job 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 Sciences 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), Bispecific Antibodies, Small Molecules – 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 Sciences Director.

In this vital role, the Medical Sciences Director 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.

Responsibilities:

• 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

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:

Doctorate degree and 4 years of medical science experience
OR
Master’s degree and 7  years of  medical science experience 
OR
Bachelor’s degree and 9 years of medical science experience
 

Preferred Qualifications:

• 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

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.

In addition to the base salary, 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 c