Safety Pharmacology Senior Scientist

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.

Lets do this. Lets change the this vital role you will join the Safety Pharmacology Sciences team. The successful candidate will serve as a subject matter expert in nonclinical safety pharmacology partnering closely with project teams to develop and execute integrated safety pharmacology strategies that support discovery candidate selection IND-enabling packages and regulatory submissions. This role will require strong scientific judgment regulatory awareness cross-functional collaboration and the ability to translate complex nonclinical safety pharmacology data into clear actionable recommendations for project teams and governance forums. The Senior Scientist will work closely with Safety Pharmacology Sciences colleagues to shape and deliver high-quality safety pharmacology strategies across Amgens portfolio to support high-quality development decisions to enable progression of innovative therapeutics for patients. The role includes opportunities to contribute to Amgens external scientific influence through collaborations presentations publications or participation in industry working groups with the following responsibilities:

Safety Pharmacology Strategy and Project Team Support

• Serve as a Safety Pharmacology subject matter expert on cross-functional project teams developing fit-for-purpose strategies and providing strategic guidance across discovery lead optimization candidate selection IND-enabling and clinical development stages aligned with program biology modality target risk regulatory expectations and development needs.
• Design and oversee GLP and non-GLP safety pharmacology studies conducted internally or at external contract research organizations ensuring scientific rigor operational feasibility compliance and timely delivery.
• Evaluate and integrate nonclinical safety pharmacology data including cardiovascular respiratory CNS ECG hemodynamic telemetry and related endpoints to assess biological relevance translational significance and regulatory impact.
• Integrate safety pharmacology data with toxicology pharmacology translational biology DMPK clinical and regulatory information to support weight-of-evidence decision-making.
• Contribute to internal governance presentations project team discussions regulatory strategy meetings development milestone decisions and resolution of study-related scientific or technical issues.

• Contribute to safety pharmacology sections of regulatory documents including IND-enabling summaries Investigators Brochures briefing documents responses to regulatory questions and internal development reports.

Scientific Leadership and Innovation

• Contribute to development and implementation of innovative safety pharmacology approaches including fit-for-purpose study designs risk-based assessment frameworks and translational safety strategies.
• Stay current with evolving regulatory expectations industry best practices scientific literature and emerging methodologies in safety pharmacology.
• Participate in internal initiatives to improve safety pharmacology processes templates data standards reporting practices and decision frameworks.
• Promote high scientific standards quality and compliance across internal and external study activities.
• Contribute to a culture of scientific curiosity collaboration accountability and continuous improvement.

External Engagement

• Represent Amgen externally through scientific presentations publications professional societies consortia or cross-industry working groups as appropriate.
• Build external scientific relationships that enhance Amgens visibility and influence in safety pharmacology.
• Monitor and contribute to emerging best practices in cardiovascular respiratory CNS and integrated nonclinical safety assessment.

Basic Qualifications:

• Doctorate degree and 1 year of scientific experience
  OR
• Masters degree and 3 years of scientific experience
  OR
• Bachelors degree and 5 years of scientific experience

Preferred Qualifications

• PhD in Pharmacology Neuroscience Physiology Biomedical Sciences or related field

• Experience supporting discovery and development project teams as a safety pharmacology SME or toxicology representative.
• Broad experience in nonclinical safety pharmacology across cardiovascular respiratory and CNS domains

• Experience serving as a study director project representative or subject matter expert for GLP and/or non-GLP safety pharmacology studies
• Experience authoring or contributing to regulatory documents such as Investigators Brochures IND sections briefing documents or responses to regulatory questions.
• Strong cross-functional communication and problem-solving skills.
• Demonstrated ability to collaborate across disciplines influence without direct authority and manage multiple priorities in a matrixed environment.
• Track record of scientific publications and participation in external scientific forums or consortia.

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