Clinical Scientist Associate Director, Cardiovascular

At Amgen if you feel like youre part of something bigger its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980 weve helped pioneer the world of biotech in our fight against the worlds 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 youll 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 youll 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

Masters degree and 5 years of clinical development experience

OR

Bachelors degree and 7 years of clinical development experience

OR

Associates 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 well 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.

Salary Range