• Contribute strategic leadership and medical expertise to the clinical development of our cutting-edge antibody portfolio in rheumatic indications. • Contribute to the study design, execution and interpretation of results, with a focus on proof-of-concept and later phases of development. • Work closely with cross-functional teams including Biostatistics, Regulatory Affairs, and Clinical Operations to support integrated and strategic trial execution. • Provide scientific/medical content and other input as appropriate for INDs, Investigator Brochures, Clinical Study reports, regulatory submissions and responses, and other program documents. Ensure compliance with regulatory standards and guidelines, including health authority requirements for MD sign-off on patient-related matters. • Ensure the safety of study participants by actively participating in safety monitoring and data review processes. • Represent the Clinical Development function in interactions with regulatory agencies, investigators, KOLs, and other external stakeholders, as appropriate.

Role Description The Sr. Medical Affairs Governance & Education Coordinator provides oversight for the medical staff governing documents and related committees to ensure regulatory and statutory compliance. Qualifications - Experience in medical affairs or related field. - Strong understanding of regulatory and statutory compliance. - Excellent communication and organizational skills. Requirements - Oversight of medical staff governing documents. - Management of related committees. - Ensuring compliance with regulations. Benefits - Comprehensive health care solutions. - Opportunities for professional growth. - Supportive and inclusive workplace environment. Company Description Mount Sinai Health System is one of the largest academic medical systems in the New York metro area, with more than 48,000 employees working across eight hospitals, more than 400 outpatient practices, and more than 300 labs. The Health System includes: - More than 9,000 primary and specialty care physicians. - 13 joint-venture outpatient surgery centers throughout New York City, Westchester, Long Island, and Florida. - More than 30 affiliated community health centers. Mount Sinai is consistently ranked by U.S. News & World Report's Best Hospitals, receiving high "Honor Roll" status.

Global Safety Medical Director - Global Safety Officer, Oncology remote type Remote locations United States - Remote time type Full time job requisition id R-248265 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. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. 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 Medical Director What you will do Let’s do this. Let’s change the world. In this vital role the Global Safety Medical Director serves two vital roles for the therapeutic area: Safety expert of the assigned product(s), establishing the strategy, direction, and priorities of pharmacovigilance activities. The role is accountable for the overall safety profile and all product-related decisions and deliverables for assigned products. Leads the Safety Analysis Team (SAT), Global Safety Team (GST) and is a core member of the Executive Safety Committee (ESC). These are cross group collaboration teams. The Global Safety Medical Director also is a member of the Evidence Generation Team. They will be assigned as delegate for the TAH as needed and has management of Global Safety Physicians. Responsibilities: - Product safety profile, benefit-risk evaluation, and risk communication - Clinical trial safety - Brochure and Informed Consent Form - New drug applications and other regulatory filings - Risk management and minimization - Commercialization Process - Inspection Readiness - Partnerships and integration activities - Participate in safety agreement development and review process - Prepare safety information to support licensing partners, review safety documents prepared by licensing partners, and communicate with licensing partners on safety matters per the safety agreement 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 - 2+ years of industry Global Safety experience - Oncology experience in early development. - Product safety in the bio/pharmaceutical industry or regulatory agency - Previous management and/or mentoring experience - Experience with oncology products/early development 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 where possible. Refer to the Work Location Type in the job posting to see if this applies. Make a lasting impact with the Amgen team. 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. Salary Range 256,606.50USD -347,173.50 USD

• Lead the clinicians supporting maternal and pediatric populations and provide clinical and operational leadership for the maternal and pediatric complex care programs. • Oversee the development, implementation, and maintenance of clinical standards, evidence-based care pathways, and educational materials across maternal and pediatric health programs. • Manage clinicians against clear performance expectations, including productivity, documentation, clinical quality, and safety standards. • Partner with other clinical leaders and cross-functional stakeholders to ensure coordination across service lines for members with multi-specialty needs. • Serve as the clinical authority for maternal and pediatric care/case management programs and provide oversight of clinical standards, escalations, and care pathways across both domains.