Safety Pharmacology Senior Scientist

BioSpace; Thousand Oaks (CA); On-site; USD 140,000 - 200,000; Full time

Benefits offered by this job

Retirement plan

Stock-based incentives

Healthcare benefits

Flexible work model

Job summary

Amgen is seeking a Safety Pharmacology Senior Scientist to lead cross-functional strategies across discovery, lead optimization, IND-enabling, and clinical development. The role emphasizes translation of nonclinical safety data into actionable guidance for project teams and governance forums.

The candidate will design GLP and non-GLP studies, integrate diverse safety data, and contribute to regulatory documents and strategy discussions to enable progression of innovative therapies for patients.

Qualifications

• PhD in Pharmacology or related field is required or PhD in a closely related discipline.
• MS/BS with substantial experience in safety pharmacology may be considered.
• Strong track record in GLP/non-GLP safety pharmacology studies and data interpretation.

Responsibilities

• Serve as Safety Pharmacology SME on cross-functional project teams.
• Design and oversee GLP/non-GLP safety pharmacology studies for discovery to development.
• Integrate nonclinical safety data to support regulatory submissions and development decisions.
• Contribute to regulatory documents such as IND sections and briefing documents.

Skills

Safety pharmacology

Cross-functional leadership

Regulatory awareness

Data interpretation

Education

PhD in Pharmacology or related field

Master's degree in a related science

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.

Safety Pharmacology Senior Scientist

Lets do this. Lets change the world. In 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.

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.

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.

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 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.