Scientific Associate Director Safety Pharmacology

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. 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 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 & Talant 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 cellderived 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
Masters degree and 7 years of relevant scientific experience
OR
Bachelors degree and 9 years of relevant scientific experience

Preferred Qualifications:

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