Clinical Scientist Associate Director – Early Development Inflammation

amgen; United States; On-site; USD 192,597 - 260,573; Full time

Job summary

Amgen is seeking a Clinical Scientist Associate Director – Early Development Inflammation to lead data quality in early-phase trials and collaborate with cross-functional teams. The role focuses on protocol development, data review, and regulatory documentation to drive decision-ready clinical data.

Qualified candidates will have relevant doctoral or masters-level experience in clinical development, strong communication skills, and a track record in regulatory submissions and data analysis tools

Qualifications

• Doctorate degree with clinical development experience.
• Master’s/PhD preferred with regulatory exposure.
• Bachelor’s with long-term clinical development experience acceptable.

Responsibilities

• Support early phase clinical trials with focus on data quality.
• Assist in protocol writing, Investigators Brochures and regulatory documents.
• Contribute to data management plans and CRF design.
• Support data review and presentation for decision-making and submissions.
• Coordinate with CROs and collaborators to meet project goals.
• Help translate clinical strategy into study documents and protocols.

Skills

Clinical development experience

Communication & presentation

Regulatory submission support

Data analysis (Spotfire)

Education

Doctorate degree

Master’s degree

Bachelor’s degree

Associate’s degree

High school diploma / GED

Tools

Spotfire

Job description

Career Category

Clinical Development

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.

Clinical Scientist Associate Director – Early Development Inflammation

WHAT YOU WILL DO

Let’s do this. Let’s change the world. In this role, the Clinical Scientist Associate Director supports Inflammation early 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 early 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




• 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.

In any materials you submit, you may redact or remove age‑identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

Application deadline

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.

Sponsorship

Sponsorship for this role is not guaranteed.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

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.

Salary Range

192,597.25USD -260,572.75USD