Senior Director - Safety Pharmacology Sciences

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like you're part of something bigger, it's because you are. At Amgen, our shared mission-to serve patients-drives all that we do. It is key to our becoming one of the world's leading biotechnology companies. We are global collaborators who achieve together-researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It's time for a career you can be proud of.

Senior Director - Safety Pharmacology Sciences

Live

What you will do

Let's do this. Let's change the world. The Translational Safety and Bioanalytical Sciences (TS&BA) function at Amgen is exploring candidates for Senior Director to serve as a group leader of our Safety Pharmacology Sciences (SPS) team. This scientific leadership position reports to the Executive Director of Translational Safety Research (TSR), a vital lab-based organization within TS&BA. The Senior Director will drive the strategic vision for the SPS team, develop translational safety strategies to support project teams and diverse drug modalities, assure lab staff and resources (capacity and capability) are aligned to deliver results, and contribute subject matter expertise to address nonclinical and clinical safety issues. In addition, the Senior Director will develop internal relationships with other TS&BA experts, cross-functional stakeholders (Medicinal Chemistry, PKDM, etc.), and contribute as a senior advisor at internal safety venues (e.g., Portfolio Scientific Advisory Committee; Portfolio Impact Meeting), represent TS&BA/TSR on R&D Initiatives, and actively contribute to the evolution of our strategic vision. . The Senior Director should hold deep subject matter expertise in a particular safety pharmacology or toxicology specialty area (e.g., integrated nonclinical-clinical QTc risk assessment, safety pharmacology evaluation of novel modalities, human translation of preclinical cardiovascular signals, exposure-response analysis, etc.). The Senior Director will participate in external industry initiatives to advance and improve drug safety assessment paradigms.

As the Safety Pharmacology Sciences group leader, you will manage a team and be responsible for skill development (e.g., scientific, technical, leadership) of your staff through coaching, identifying experiential learning opportunities, and ensure career development plans continuously evolved. In partnership with your team, you will influence the development of fit-for-purpose translational safety strategies based on a strong scientific foundation, flexibly evolve the strategy in response to team goals and emerging data and encourage effective team behaviors. A strong understanding of the expertise and toolbox available at Amgen will be developed through networking to fully leverage our internal and external resources. It is expected that you will apply your drug development and regulatory experience to the novel targets and/or modalities in Amgen's pipeline.

The Senior Director will have a key leadership role within TSR to ensure optimal communication and cross-functional alignment with multiple stakeholders within TS&BA (e.g., Project Team Representatives; Pathology; Comparative Medicine, etc.), Research (e.g., Medicinal Chemistry, TA Scientists, etc.) and Clinical Development (e.g., Clinical Pharmacology & Modeling, Global Safety, etc.), for example. The important role will provide deep safety pharmacology and drug safety expertise to ensure and enable robust nonclinical safety strategies and regulatory submissions.

The Senior Director is a scientific leadership role that reports to the Executive Director of Translational Safety Research, a vital lab-based organization in TS&BA. This role requires periodic travel to Amgen R&D sites (USA; EU) including site visits to external lab partners.

The successful candidate will have:

• Organizational leadership experience including leadership of lab-based team, results delivery, proven track record of staff development, and leading within a dynamic organization.

• Expert knowledge of principles and theories in pharmacology, safety pharmacology and toxicology with proficient knowledge of related disciplinary areas such as Pharmacokinetics.

• In-depth knowledge of the cross-functional processes behind drug discovery and development, a strong understanding of partner needs, and the ability to develop integrated safety pharmacology-toxicology study plans.

• Experience with nonclinical safety submissions to global Health Authorities.

• Deep expertise in stages of development preceding First-in-Human with a passion for biological understanding and application of biological insights to safety assessment.

• Experience with safety pharmacology approaches for various modalities, e.g., small and large molecules, including fit-for-purpose study designs.

• Working knowledge of GLP regulations and guidelines, including ICH S7B/E14 Q&As.

• Prior work experience at, or collaborating with, contract research organizations.

• Interest and ability to serve as a Subject Matter Expert in a specific area.

• Excellent and professional verbal and written communication skills; demonstrated ability to influence a broad spectrum of partners toward achieving business goals.

Basic Qualifications:

Doctorate degree PhD OR PharmD OR MD [and relevant post-doc where applicable] and 7 years of relevant experience

Or

Master's degree and 10 years of relevant experience

Or

Bachelor's degree and 12 years of relevant experience

Preferred Qualifications:

• 15 years of drug development experience, including early preclinical pipeline projects and platforms. support of clinical-stage assets and regulatory submissions, e.g., IND filings.

• Experience with leading, managing and mentoring a diverse team of nonclinical safety scientists.

• Ability to develop and drive functional strategy and lead cross-functional teams or initiatives.

• Preclinical safety assessment experience across multiple therapeutic areas and multiple therapeutic modalities, e.g., small molecules, proteins, etc.

• Expertise in developing nonclinical safety strategies for new modalities or to address unique safety concerns and resolving safety-related issues.

• Deep subject matter expertise in a particular safety pharmacology or toxicology area, e.g., integrated nonclinical-clinical QTc risk assessment, safety pharmacology evaluation of novel modalities, human translation of preclinical cardiovascular signals, exposure-response (PK/PD) analysis, drug-abuse liability, etc.

• External visibility and scientific eminence demonstrated by a strong external presentation and publication record

Thrive

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for our teammates' professional and personal growth and well-being.

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.

Amgen offers a Total Rewards Plan comprising 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 including:

• 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 and bi-annual company-wide shutdowns

• Flexible work models, including remote work arrangements, where possible

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

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Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

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.