Clinical Scientist Associate Director, Late Development Oncology

Amgen SA; Northern (KY); On-site; USD 180,000 - 240,000; Full time

Benefits offered by this job

Retirement plan

Health, dental, vision benefits

Stock-based incentives

Award-winning time-off plans

Flexible work models

Job summary

Amgen is seeking a Clinical Scientist Associate Director to lead late-phase oncology development efforts, coordinating protocol development, start-up, data review, and regulatory support. The role emphasizes cross-functional teamwork, data integrity, and strategic execution across trials.

You will collaborate with clinical leadership to ensure high-quality data and timely regulatory submissions, contributing to study design, monitoring, and cross-team alignment in a fast-paced environment.

Qualifications

• Doctorate degree and 3 years of clinical development experience
• Master’s degree and 5 years of clinical development experience
• Bachelor’s degree and 7 years of clinical development experience
• Associate’s degree and 12 years of clinical development experience
• High school diploma / GED and 14 years of clinical development experience
• Experience contributing to regulatory submission documents and regulatory responses
• Experience in design, monitoring, and implementation of clinical trials in Good Clinical Practice standards

Responsibilities

• Support set up and execution of late 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 and 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
• Assist in management of collaborators, consultants, and/or CROs for key projects
• Anticipate and actively manage problems across cross-functional teams
• Work cross-functionally to translate clinical strategy into study concepts and protocols
• Support training, recruitment, and development requirements for matrix team resources

Skills

Communication skills

Presentation skills

Cross-functional collaboration

Clinical data analysis

Regulatory document support

Study data readout

Education

Doctorate degree

Master’s degree

Bachelor’s degree

Associate’s degree

High school diploma / GED

Tools

Spotfire

Job description

Join Amgen’s Mission of Serving Patients

At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.

Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

WHAT YOU WILL DO

Let’s do this. Let’s change the world. In this role, the Clinical Scientist Associate Director supports oncology late-phase clinical development by contributing to protocol development, study start-up, data review and monitoring and analysis activities. Working collaboratively with the study team and clinical leadership, this role focuses on study-level implementation and cross-functional coordination to help ensure high-quality, decision-ready clinical data.

• Support set up and execution of late 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 and 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 the management of 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 resources.

WHAT WE EXPECT OF YOU

We are all different, yet we all use our unique contributions to serve patients. The clinical development professional we seek is a leader with these qualifications.

Basic Qualifications:

Doctorate degree and 3 years of clinical development experience

OR

Master’s degree and 5 years of clinical development experience

OR

Bachelor’s degree and 7 years of clinical development experience

OR

Associate’s degree and 12 years of clinical development experience

OR

High school diploma / GED and 14 years of clinical development experience

Preferred Qualifications:

• 3 years of experience in a pharmaceutical industry setting with at least 1 year supporting early or late-phase clinical development within a relevant therapeutic area or disease indication (oncology preferred)
• Demonstrated experience contributing to clinical trial process improvements within a therapeutic area or study team environment
• Strong communication and presentation skills, with the ability to clearly convey scientific concepts and clinical data to cross-functional teams and leadership audiences, both written and oral
• Experience supporting the design, monitoring, and implementation of clinical trials in compliance with Good Clinical Practice standards and applicable regulatory requirements
• Working knowledge of study data readout activities, including data cleaning, database lock, data extraction, and generation of clinical data outputs
• Experience contributing to regulatory submission documents and supporting clinical regulatory responses for health authority interactions under guidance
• Experience serving as a contributing author on scientific publications or data presentations for internal forums or 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 your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.

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.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of 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 that may include:

• A 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

• Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.