Global Safety Medical Director, Immuno-oncology

Global Safety Medical Director, Immuno-oncology

Global Safety Medical Director, Immuno-oncology role at Amgen. In this vital role you will serve as the safety expert of the assigned product(s) within the Rare Disease portfolio. You will establish the strategy, direction, and priorities of pharmacovigilance activities and are accountable for the overall safety profile and all product-related decisions and deliverables for assigned products. You will lead the Safety Analysis Team (SAT), Global Safety Team (GST) and be a core member of the Executive Safety Committee (ESC). You will also be a member of the Evidence Generation Team and may be delegated for the Therapeutic Area Head (TAH). You will work in a fast-paced environment with a dynamic team of safety physicians and scientists dedicated to bringing important therapies to patients in need.

Key Activities

• Validate safety signals and lead safety signal assessments
• Develop and maintain Core Safety Information (core data sheet, core risks in informed consent forms, etc.)
• Prepare/review core and regional risk management plans including additional risk minimization measures
• Prepare/review safety sections of periodic aggregate reports
• Provide safety input to protocols, statistical analysis plans, and clinical study reports
• Prepare/review safety sections of new drug applications and other regulatory filings
• Serve as safety expert on Evidence Generation Team for assigned products
• Inspection Readiness
• Domestic and International travel up to 10%

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

• MD or DO degree from an accredited medical school
• Completion of an accredited medical or surgical residency
• Clinical experience in either an accredited academic setting or private practice (including hospital-based) setting

Preferred Qualifications

• Product safety in the bio/pharmaceutical industry or regulatory agency
• Expertise in Rare Disease therapeutic area, or clinical training
• Experience with marketed product safety; risk management
• Experience with phase 1-3 clinical trials safety assessments and analyses
• Drug Submission experience
• Leadership experience of the safety profile of products assigned with cross-functional team members

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, 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 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, including remote and hybrid work arrangements, where possible

Apply now and make a lasting impact with the Amgen team.

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.

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.

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.

Seniority level

• Director

Employment type

• Full-time

Job function

• Health Care Provider

Industries

• Internet News