Clinical Scientist Associate Director – Cardiovascular Trials

Career Category

Job Description

Join Amgens Mission of Serving Patients

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

Lets do this. Lets change the this vital role the Clinical Scientist Associate Director will support the execution of cardiovascular trials by translating scientific and clinical strategy into high-quality study delivery across global complex late-stage clinical trials. The Clinical Scientist serves as a key clinical development team member providing hands-on oversight of protocol execution medical data review endpoint quality and cross-functional issue resolution to enable timely decision-ready data. This role works collaboratively across clinical medical operational data management safety and regulatory teams to ensure studies are conducted in alignment with protocol intent study timelines regulatory expectations and Amgen quality standards.

• Serve as a clinical and scientific subject-matter expert for cardiovascular trials with deep understanding of cardiovascular disease endpoint strategy protocol execution and data integrity.

• Contribute to medical monitoring activities and support ongoing review of subject-level and aggregate clinical data to identify safety signals endpoint trends protocol deviations and emerging operational or scientific risks.

• Present information internally and externally anticipating and actively managing issues across a broad spectrum of cross-functional stakeholders governance bodies and external partners.

• Provide guidance and oversight in the identification and management of collaborators consultants adjudication vendors and/or Clinical Research Organizations (CROs) to support successful trial delivery.

• Work cross-functionally to translate clinical strategy into study concept documents protocols endpoint definitions charters data review plans and other key trial documents required for CV trial execution.

• Ensure the scientific and operational integrity of protocols and clinical plans including delivery of final protocol content and governance approvals for large global event-driven studies.

• Provide clinical input into study startup trial conduct enrollment oversight endpoint ascertainment adjudication readiness data review and interpretation of results.

• Review and analyze clinical trial data to ensure accuracy completeness consistency and adherence to protocol endpoint definitions and regulatory requirements with strong focus on MACE and other cardiovascular outcome measures where applicable.

• Lead thorough data quality assessments in the context of a data monitoring and review plan to maintain high standards of endpoint reliability safety oversight and inspection readiness throughout the trial lifecycle.

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 ofclinical science experience
OR
Masters degree and 5 years of clinical science experience
OR
Bachelors degree and 7 years ofclinical science experience
OR
Associates degree and 12 years of clinical science experience
OR
High school diploma / GED and 14 years of clinical science experience

Preferred Qualifications:

• 3 years of pharmaceutical clinical drug development experience including meaningful experience supporting late-stage global clinical trials.

• Strong preference for individuals with a proven track record of clinical trial execution inspection readiness and process improvement in complex development programs.

• Industry or academic experience in cardiovascular medicine and/or cardiovascular outcomes trials; experience in large event-driven studies strongly preferred.

• Strong communication and presentation skills to clearly communicate scientific concepts risk assessments and clinical data to leadership committees and external stakeholders in both written and oral formats.

• Experience designing monitoring and implementing global clinical trials including interpretation of test results and subject-level data in compliance with Good Clinical Practice standards and regulatory requirements.

• Understanding 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 submissions and health authority responses including preparation of high-level clinical content and issue-resolution materials.

• Experience contributing to scientific publications congress abstracts and data presentations at scientific conferences.

• Experience in clinical data review and analysis tools such as Spotfire listings review platforms or other data visualization and 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 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.

Apply now and make a lasting impact with the Amgen team.

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