Global Safety Medical Director, Rare Disease

Global Safety Medical Director, Rare Disease

remote type

Remote

locations

United States - Remote

time type

Full time

posted on

Posted Yesterday

job requisition id

R-240778

Career Category Safety

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.

Global Safety Officer, Medical Director, Rare Disease

What you will do

Let’s do this. Let’s change the world.

In this vital role, you will serve as the strategic safety leader for assigned Rare Disease assets within Amgen's global development organization. You will be accountable for the overall benefit-risk profile, safety strategy, signal management, and safety governance of clinical programs, with a primary focus on early clinical development (Phase 1b and Phase 2 studies).

This role is ideal for a physician who has served as a Global Safety Officer (GSO), Clinical Safety Lead, Safety Lead Physician, or equivalent accountable safety leader for development-stage assets and has directly influenced key clinical development decisions through safety leadership.

The successful candidate will bring expertise in Rare Disease drug development and ideally experience within inflammatory, neuroinflammatory, autoimmune, complement-mediated, vasculitis, endocrine, metabolic, genetic, or other orphan disease indications.

You will establish the strategy, direction, and priorities of pharmacovigilance activities and will be accountable for the overall safety profile and safety-related decisions for assigned products.

You will lead the Safety Analysis Team (SAT), Global Safety Team (GST), and serve as a core member of the Executive Safety Committee (ESC). You will partner closely with Clinical Development, Translational Medicine, Regulatory, Biostatistics, and Medical Affairs to influence development strategy and support innovative therapies for patients with rare diseases and high unmet medical need.

Responsibilities

• Serve as the accountable physician safety leader for assigned Rare Disease development programs.

• Lead global safety strategy for clinical development programs with a primary focus on Phase 1b and Phase 2 studies.

• Partner with Clinical Development and Translational Medicine teams to inform dose-escalation, cohort expansion, proof-of-concept, and development decisions.

• Provide medical safety leadership and contribute to benefit-risk evaluations throughout clinical development.

• Review and interpret emerging safety data and communicate safety implications to development teams and governance committees.

• Lead Safety Analysis Team (SAT), Global Safety Team (GST), and participate in Executive Safety Committee (ESC) discussions.

• Review and contribute to Safety Review Committees (SRCs), Data Monitoring Committees (DMCs), and other safety governance forums.

• Validate safety signals and lead signal detection, assessment, and risk evaluation activities.

• Develop and maintain Core Safety Information including Core Data Sheets and informed consent safety language.

• Prepare and review Risk Management Plans (RMPs), risk minimization strategies, and aggregate safety reports.

• Lead safety review and provide strategic input into protocol development, CRF design, Statistical Analysis Plans, Clinical Study Reports, and safety monitoring plans.

• Prepare and review safety sections of regulatory submissions including INDs, CTAs, BLAs, NDAs, and other global submissions.

• Serve as the safety representative on Evidence Generation Teams and other cross-functional development teams.

• Support regulatory inspections and inspection readiness activities.

• 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 Global Safety Officer we seek is a leader with these qualifications.

Basic Qualifications:

• MD or DO degree from an accredited medical school
• AND
• Completion of an accredited medical or surgical residency
• OR
• Relevant clinical experience in an academic, hospital-based, or private practice setting.

Preferred Qualifications:

• 8+ years of pharmaceutical industry experience in Drug Safety, Clinical Safety, Pharmacovigilance, or Clinical Development.

• Demonstrated experience serving as a Global Safety Officer (GSO), Clinical Safety Lead, Safety Lead Physician, or equivalent accountable safety role.

• Significant experience supporting Phase 1b and Phase 2 clinical development programs.

• Experience in Early Clinical Development, including First-in-Human, dose escalation, cohort expansion, proof-of-concept, and translational medicine programs.

• Direct experience influencing clinical development through protocol development, CRF design, safety monitoring plans, dose-escalation decisions, and benefit-risk assessments.

• Expertise in signal detection, signal assessment, benefit-risk evaluation, risk management, and safety governance.

• Experience supporting regulatory submissions and interactions with health authorities, including INDs, CTAs, BLAs, NDAs, MAAs, and responses to regulatory questions.

• Experience presenting safety assessments and recommendations to governance committees, development teams, and regulatory authorities.

• Experience supporting Rare Disease clinical development programs strongly preferred.

• Expertise in inflammatory, neuroinflammatory, autoimmune, complement-mediated, vasculitis, endocrine, metabolic, genetic, or other orphan disease indications strongly preferred.

• Experience supporting biologics, monoclonal antibodies, gene therapies, or other innovative modalities in clinical development preferred.

• Demonstrated leadership in cross-functional matrix organizations with the ability to influence development strategy and drive decision-making.

• Experience with both clinical development and post-marketing safety activities preferred.

• 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, including remote and hybrid work arrangements, where possible

• Sponsorship

• 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