Clinical Scientist Associate Director, Late Development Oncology

Join Amgen’s mission of serving patients. At Amgen, 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 a 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-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.

About the role

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.

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 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.

Requirements

• 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

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

Benefits

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