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Safety Pharmacology Senior Scientist

BioSpace

Join Amgen’s mission of serving patients. At Amgen, if you feel like you are part of something bigger, it is because you are. Our shared mission to serve patients living with serious illnesses drives all that we do. Since 1980, we have 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‑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. Safety Pharmacology Senior Scientist What you will do 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 requires 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 Amgen’s portfolio to support high‑quality development decisions and enable progression of innovative therapeutics for patients. The role includes opportunities to contribute to Amgen’s external scientific influence through collaborations, presentations, publications, or participation in industry working groups. 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. 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, Investigator’s 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. Build external scientific relationships that enhance Amgen’s 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 Masters degree and 3 years of scientific experience Bachelor’s 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 Investigator’s 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 We work to develop treatments that take care of others, and we also care for your professional and personal growth and well‑being. From our competitive benefits to our collaborative culture, we fully 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 Health and Welfare Plans for staff and eligible dependents, Financial Plans, work/life balance, and career development opportunities. The benefits 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 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. #J-18808-Ljbffr BioSpace

Vacancy posted 1 day ago
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