Clinical Development Director, Early Development – Inflammation/Rare Disease

Career Category Clinical Development 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. Clinical Development Director What you will do Let’s do this. Let’s change the world. In this vital role, you will lead the early phase clinical development of compounds from first-in-human studies through proof-of-concept. You will collaborate on teams to support the design and delivery of early phase clinical trials. Through this role, the Clinical Medical Director will support protocol and IND development, study start up, data review, monitoring and analysis activities.

Contribute to the design and implementation of the early clinical development strategy for Inflammation, General Medicine or Rare Disease therapeutic candidates Contribute to the preparation of clinical development plans, clinical study protocols, informed consents, Investigator Brochures, and Ethics Committee and regulatory agency submissions Review and evaluate clinical study safety, efficacy, pharmacodynamic and pharmacokinetic data Contribute to the strategy and use of clinical biomarkers to facilitate drug development Actively collaborate with Amgen Precision Medicine, Research, Clinical Pharmacology, Operations, Late Development, Regulatory, Safety and Commercial colleagues Contribute to the evaluation of external licensing or partnering opportunities within the cardiometabolic/general medicine therapeutic areas Collaborate with external experts to provide biomedical expertise and strategic guidance to Early Development teams What we expect of you We are all different, yet we all use our unique contributions to serve patients. The Early Development professional we seek is a Leader with these qualifications.

MD or DO degree from an accredited medical school AND 2 years of industry or academic/basic sciences/clinical development experience Preferred Qualifications: Board certification or eligible (Internal Medicine, relevant subspecialty) Residency training in Internal Medicine and relevant subspecialty Understanding of pathophysiology of inflammatory, general medicine, and/or rare diseases Experience in basic research and/or clinical trial methodology 3+ years of relevant drug development experience in the pharmaceutical industry and/or academia, preferably in early stage clinical trials Experience collaborating with pharmaceutical sponsors Experience in designing, monitoring and implementing clinical trials and interpreting trial results Demonstrated leadership qualities; capable of conducting studies as part of a team Experience within a matrix environment, contributes to decision-making and reaching alignment in order to meet challenging timelines Publication track record Excellent interpersonal and presentation skills; able to communicate effectively with internal stakeholders, as well as external partners and collaborators What you can