Associate Medical Sciences Director, Early Clinical Development- Rheumatology/Immunology
Career Category Clinical DevelopmentJob DescriptionJoin Amgen’s Mission of Serving PatientsAt 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.Associate Medical Science Director, Early Clinical DevelopmentWhat you will doLet’s do this. Let’s change the world. In this vital role you will contribute to 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 Associate Medical Sciences Director will support clinical development activities including protocol development, study start up, data review, monitoring and analysis activities.Contribute to the design and implementation of the early clinical development strategy for Inflammation therapeutic candidatesContribute to the preparation of clinical development plans, clinical study protocols, informed consents, Investigator Brochures, and Ethics Committee and regulatory agency submissionsReview and evaluate clinical study safety, efficacy, pharmacodynamic and pharmacokinetic dataContribute to the strategy and use of clinical biomarkers to facilitate drug developmentActively collaborate with Amgen Precision Medicine, Late Development, Discovery Research, Regulatory, and Commercial colleaguesCollaborate with external experts to provide biomedical expertise and strategic guidance to Inflammation Early Development teamsWhat we expect of youWe 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
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1 years of clinical research and/or basic science research experiencePreferred Qualifications:
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AND
1 years of clinical research and/or basic science research experiencePreferred Qualifications:
- Board certification or eligible
- Residency training in Internal Medicine and relevant subspecialty
- Understanding of immunology and inflammatory diseases
- Experience in basic research and/or clinical trial methodology
- 2+ years of Inflammation 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
- Communicate effectively with internal stakeholders, as well as external partners and collaborators
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