Scientific Associate Director - Safety Pharmacology

Amgen Inc. (IR); Thousand Oaks (CA); On-site; USD 194,000 - 263,000; Full time

Benefits offered by this job

Retirement and Savings Plan

Stock-based long-term incentives

Flexible work models where possible

Job summary

Amgen Inc. seeks a Scientific Associate Director for Safety Pharmacology to lead lab-based safety efforts within Translational Safety & Risk Sciences. You will oversee the cardiac safety and electrophysiology lab, manage staff, and guide study design and interpretation for regulatory filings.

You will shape safety strategy across modalities, collaborate with CROs, and develop external partnerships while advancing industry best practices in NAMs and stem-cell models.

Qualifications

• Doctorate or Master’s degree with relevant experience or Bachelor’s with years of experience.
• Experience leading safety pharmacology labs and staff.
• Familiarity with GLP and regulatory expectations.

Responsibilities

• Lead cardiac safety and electrophysiology lab operations and staffing.
• Coordinate in vitro and in vivo safety studies and data review.
• Serve as SME on project teams for safety strategy.
• Collaborate to advance mechanistic safety understanding externally.

Skills

Leadership

Safety pharmacology

Data interpretation

Cross-functional communication

Project management

Education

Doctorate degree (PhD)

Master's degree

Bachelor's degree

Tools

hERG assays

hiPSC-derived cardiomyocytes

NAMs models

Job description

Career Category Scientific Job Description Join Amgen's Mission of Serving Patients At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission - to serve patients living with serious illnesses - drives all that we do. Since 1980, we've 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. 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. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Scientific Associate Director - Safety Pharmacology

What you will do Let’s do this. Let’s change the world. The Scientific Associate Director will lead safety pharmacology lab-based activities within the Safety Pharmacology Sciences team and contribute directly to the success of Translational Safety & Risk Sciences (TSRS), the department responsible for nonclinical safety evaluation within Amgen Research. This role reports to the Senior Director of Safety Pharmacology Sciences. This leadership role has multiple components: management of in vitro cardiac safety and electrophysiology laboratory and staff; lead and coordinate safety issue resolution studies (in vitro; in vivo); serve as a Safety Pharmacology Subject Matter Expert (SME) on project teams; and contribute to external scientific initiatives. The role requires integration of data across multiple assay systems and modalities to support candidate selection, risk assessment, clinical translation, regulatory strategy, and advancement of industry best practices.

Key Responsibilities

1. Laboratory Leadership & Talent Management Oversee the cardiac safety and electrophysiology laboratory, a core function responsible for ion channel, hiPSC-derived cardiomyocyte, and isolated heart assays. Manage exploratory and GLP-compliant studies, including outsourcing, protocol development, data review, and report finalization. Supervise scientific staff, promote their development and ensure high-quality timely data generation, study tracking, QC, reporting and stakeholder communication. Maintain compliance with data integrity, safety, and environmental standards. Interface with internal & external partners to establish qualified NAMs models for safety assessment.
2. Safety Pharmacology Subject Matter Expert (SME) on TSRS Teams Provide expertise to support discovery and development programs and partner with TSRS project team representative (PTR) and other team members (PKDM, pathology, etc) to ensure aligned and efficient execution of safety strategies. Ensure appropriate evaluation of target- and off target-based safety risks for diverse drug modalities in accordance with evolving ICH guidelines (S7A, S7B/E14, etc.). Guide study design, data interpretation, and next-step recommendations to support both lead optimization and clinical candidate selection and contribute to regulatory filings or inquiries. Provide oversight of safety pharmacology strategy across modalities, including small molecules, biologics, and emerging therapeutic approaches Coordinate investigative studies (e.g. human primary tissue acquisition, functional studies, etc.) and partner with internal and external (CRO) labs to execute. Collaborate with relevant experts to evaluate and integrate in vitro and in silico approaches.
3. External Scientific Influence Build and maintain external collaborations with academic, industry, and consortium partners to advance mechanistic safety understanding and safety pharmacology best practices. Develop scientific eminence through peer-reviewed publications, presentations, and invited talks. Promote adoption of human-relevant in vitro models (e.g., stem cell-derived cardiomyocytes and other NAMs). Contribute to industry thinking on emerging modality-specific safety considerations (e.g., oligonucleotides and novel therapeutics).

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 relevant post-doc where applicable] and 4 years of relevant scientific experience OR Master's degree and 7 years of relevant scientific experience OR Bachelor's degree and 9 years of relevant scientific experience

Preferred Qualifications

• PhD in Pharmacology, Neuroscience, Physiology, Biomedical Sciences, or related field
• Broad experience in in vitro and or in vivo safety pharmacology across cardiovascular, respiratory and CNS domains
• Working knowledge of cardiac ion channel assays (e.g., hERG, Nav1.5, Cav1.2) and hiPSC-derived cardiomyocyte and isolated heart assays
• Experience managing outsourced studies and CRO relationships
• Experience supporting discovery and development project teams as a safety pharmacology SME or toxicology representative.
• Familiarity with GLP-enabling safety pharmacology packages and integration with toxicology studies
• Demonstrated people leadership and laboratory management experience
• Strong cross-functional communication and problem-solving skills
• 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, we'll 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.

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.

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.

Salary Range 194,274.30USD -262,841.70 USD

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. For more information, visit www.amgen.com and follow us on www.twitter.com/amgen.