Global Safety Medical Director, Early Development Rare Disease
Amgen
United States - RemotePosted about 1 month agoDiscoveredMatch locked
RemoteFull time
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.
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 across early and late-stage clinical development and, where applicable, post-marketing activities. You will be accountable for the ongoing benefit-risk assessment, safety strategy, signal detection and evaluation, regulatory safety deliverables, and cross-functional leadership required to support global development programs and bring innovative therapies to patients.
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 also lead the Safety Analysis Team (SAT), Global Safety Team (GST) and is a core member of the Executive Safety Committee (ESC).
Serve as a member of the Evidence Generation Team and other relevant cross-functional teams and will be assigned as delegated for the Therapeutic Area Head (TAH).
Work in a fast-paced environment with a dynamic team of safety physicians and scientists dedicated to bringing important therapies to patients in need.
Responsibilities
- Lead safety strategy for early clinical development programs, including First-in-Human, dose-escalation, proof-of-concept, and Phase 1-2 studies
- Provide medical safety input into clinical development plans and key development decisions, including dose selection, safety monitoring approaches, and benefit-risk assessments
- Review and contribute to Safety Review Committees (SRCs), Data Monitoring Committees (DMCs), and other safety governance forums.
- Interpret emerging safety data and communicate safety implications to development teams and senior governance committees.
- 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
- Lead safety review and provide strategic input into protocol development, CRF design, Statistical Analysis Plans, safety monitoring plans, and Clinical Study Reports to ensure appropriate safety data collection and evaluation.
- 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 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
Clinical experience in either an accredited academic setting or private practice (including hospital based) setting
Preferred Qualifications
- 5+ years of drug safety/pharmacovigilance experience within the biopharmaceutical industry or regulatory environment.
- Demonstrated experience serving as a safety lead for clinical development programs across Phase 1-3 studies.
- Experience in Early Clinical Development, including First-in-Human, dose escalation, proof-of-concept, and translational medicine programs.
- Expertise in safety signal detection, signal assessment, benefit-risk evaluation, and risk management.
- Experience authoring or providing strategic leadership for protocol development, CRF design, safety monitoring plans, and clinical study conduct.
- Experience supporting regulatory submissions, including INDs, CTAs, BLAs, MAAs, NDAs, and responses to health authority requests.
- Experience presenting safety assessments to internal governance committees and health authorities.
- Expertise in Rare Disease therapeutic area and/or relevant clinical training.
- Experience leading cross-functional teams and influencing development strategy in a matrix environment.
- Experience with marketed product safety and post-marketing risk management activities.
- Ideal candidates will bring a combination of pharmaceutical drug safety leadership and early clinical development experience, with a demonstrated ability to shape clinical program strategy through protocol development, safety monitoring, benefit-risk assessment, and regulatory interactions.
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
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
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. 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 for the position.
Sponsorship
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.
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Salary Range
256,606.50USD -347,173.50 USD
Not included in the source posting: benefits.
Who can apply
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