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, Cardiovascular
What you will do
In this role, the Clinical Scientist Associate Director supports the design, execution, and oversight of cardiovascular trials and other late-phase global clinical studies. The role contributes to protocol development, study execution, medical monitoring support, and clinical data review, ensuring delivery of high-quality, decision-ready clinical data for regulatory submissions and scientific dissemination.
-
Support the design, start-up, and execution of global cardiovascular trials, ensuring adherence to protocol, regulatory requirements, and data integrity standards.
-
Contribute to development of clinical protocols, statistical analysis plans, investigator brochures, and regulatory documents, with particular focus on cardiovascular endpoints and safety outcomes.
-
Collaborate with cross-functional teams to support endpoint strategy, event adjudication processes, and cardiovascular safety monitoring.
-
Participate in development and oversight of endpoint adjudication charters, safety monitoring plans, and Data Monitoring Committee (DMC) interactions.
-
Provide clinical input into data management plans, CRF design, and clinical data review, with focus on cardiovascular outcomes endpoints (e.g. MACE, hospitalization events, mortality) and/or cardiac imaging endpoints.
-
Conduct ongoing clinical data review and signal detection, supporting identification and resolution of safety and data quality issues across global trial sites.
-
Support preparation and interpretation of interim analyses, database lock activities, and top-line data readouts.
-
Assist Development Lead and Clinical Scientist Director with medical monitoring activities and oversight of CROs, vendors, and adjudication committees.
-
Collaborate with clinical operations, biostatistics, safety, regulatory, and medical affairs teams to ensure successful delivery of cardiovascular outcomes and/or cardiac imaging studies.
-
Contribute to clinical study reports, regulatory submissions, scientific publications, and presentations for internal and external stakeholders.
-
Identify operational or scientific risks and proactively implement mitigation strategies across cross-functional teams.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The dynamic 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 pharmaceutical clinical drug development experience, including experience supporting late-stage, global clinical trials.
-
Demonstrated experience contributing to clinical trial process improvements within a therapeutic area or study team environment
-
Industry or academic experience in cardiovascular medicine and/or cardiovascular outcomes trials; experience in large event-driven studies preferred.
-
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, endpoint validation, and generation of analysis outputs to support topline and final results.
-
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 review and analysis tools such as Spotfire, listings review platforms, or other data visualization and analysis tools.
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.
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 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.
