Clinical Sciences Associate Director Early Development, Oncology

Clinical Scientist Associate Director Early Development

Support oncology early clinical development by contributing to protocol development, study start‑up, data review, 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 setup and execution of early phase clinical trials with a focus on data quality.
• Assist in authoring clinical protocols, Investigator 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 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.

• Doctorate degree and 3 years of clinical development experience
• Masters degree and 5 years of clinical development experience
• Bachelors degree and 7 years of clinical development experience
• Associates degree and 12 years of clinical development experience
• High school diploma / GED and 14 years of clinical development experience

• 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

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.

• 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.

Final date to receive applications:
Amgen does not have an Final date to receive applications 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.

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.