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Medical Sciences Director, Late Development Blincyto

Employer
Amgen
Location
Washington D.C., District of Columbia
Start date
May 31, 2024

View more

Discipline
Science/R&D, Oncology
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Best Places to Work

Job Details

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 - Late Development

Live

What you will do

Lets do this. Lets change the world. Amgen is advancing the largest Oncology pipeline in our history spanning several innovative technology platforms Bispecific T Cell Engagers (BiTEs), 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 Late Development Group is looking for a Medical Sciences Director.

In this vital role, the Medical Sciences Director 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

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 life sciences/healthcare experience

Or

Masters degree and 7 years of life sciences/healthcare experience

Or

Bachelors degree and 9 years of life sciences/healthcare 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 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.

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 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.

Company

We are all different, yet we have this in common: our mission to serve patients. This sense of shared purpose is key to our becoming one of the world’s leading biotechnology companies. It guides us as we continue to launch new medicines and reach millions of patients worldwide.

We live the mission.

We win together.

We thrive on continual challenge.

Our team of 22,000+ scientists and professionals worldwide bring distinct perspectives and experiences to all we do. We leverage our global talent to achieve together—to research, manufacture and deliver ever-better products and greater depth to our mission.

At Amgen, there is a strong correlation between our high level of diversity and performance. Because addressing issues with a wider range of perspectives and approaches leads to more creative problem-solving. Together, we’re transforming the promise of science and biotechnology into therapies that have the power to restore health.

Connect with us to explore how you can Win, Live, and Thrive at Amgen.

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Company info
Website
Phone
805-447-1000
Location
Corporate Headquarters
One Amgen Center Drive
Thousand Oaks
California
91320-1799
US

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