Scientific Associate Director - Safety Pharmacology

BioSpace; Thousand Oaks (CA); Híbrido; USD 180 000 - 240 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Retirement plan

Medical, dental & vision

Life & disability insurance

Flexible spending accounts

Annual bonus program

Long-term incentives

Generous paid time off

Resumo da oferta

Amgen is seeking a Scientific Associate Director of Safety Pharmacology to lead lab-based safety activities within the TSRS. This role manages the safety pharmacology lab, oversees in vitro and in vivo studies, and serves as SME on project teams, guiding risk assessment and regulatory strategies.

The role requires integrating data across assays to support candidate selection, clinical translation, and industry best practices, with opportunities to publish and collaborate externally.

Qualificações

• Doctorate degree with relevant post‑doc experience or equivalent.
• 4+ years of scientific experience for Doctorate path.
• 7+ years for Masters path, 9+ years for Bachelors path.
• Broad experience in safety pharmacology across domains.

Responsabilidades

• Oversee safety pharmacology lab functions and staff.
• Lead in vitro and in vivo safety studies and risk assessment.
• Coordinate with project teams and external CROs.
• Ensure GLP data integrity and regulatory readiness.
• Publish and present scientific work to advance practice.

Conhecimentos

Leadership

Cross-functional collab

Data interpretation

Regulatory strategy

Publications

Formação académica

Doctorate degree

Masters degree

Bachelors degree

Ferramentas

CRO management

GLP knowledge

In vitro/in vivo safety pharmacology

Descrição da oferta de emprego

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

Lets do this. Lets 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

• 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.
• 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.
• 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
• Masters degree and 7 years of relevant scientific experience
• Bachelors 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 will 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.

Benefits

• 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.

careers.amgen.com

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. This will not be penalized.

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 across 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.