Medical Director Early Clinical Development, Oncology

Join Amgens Mission of Serving Patients At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do. Since 1980, weve helped pioneer the world of biotech in our fight against the worlds 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, youll 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, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Medical Director Early Clinical Development, Oncology What you will do Lets do this. Lets change the world. In this vital role you will lead early phase clinical development of compounds from first-in-human studies through proof of concept for solid tumors and blood cancers. They define, design, and deliver early phase clinical and translational projects as the initial strategy for drug development. They typically serve as clinical project leaders for one or more of Amgens Product Strategy Teams through their role as an Early Development Leader (EDL). These experts represent Early Clinical Development, Oncology internally and externally, contributing intellectual insight into experimental design and data analysis. They provide subject matter expertise in clinical and translational trial science as well as the biology and treatment of cancer. Responsible for the oversight and medical monitoring of early phase clinical studies (First-in-Human, Phase 1-2), and ensuring that all clinical studies operate to the highest ethical and safety standards and in compliance FDA, EMEA, ICH and GCP guidelines as well as Amgen SOPs regarding safety. Significant contributor to the development of the strategy for assigned compound(s)/programs and working with team members to develop a compelling business case for governance approval. Work cross functionally within teams to ensure clinical strategy is translated into the development of the study concept document, study protocol and related documents. Accountable for the integrity of protocols and/or components of clinical plans and for the delivery of final protocol and its governance approval. Responsible for providing clinical input into & implementation of clinical trial(s), their delivery, clinical data review, interpretation of results What we expect of you We 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 AND 2 years of clinical research and/or basic science research experience Preferred Qualifications: Strong preference for individuals with clinical training in oncology; subspecialty board eligibility/certification in Oncology and/or Hematology PhD or additional advanced degrees desirable Industry or academic experience in early-phase oncology drug development Strong communication & presentation skills to clearly communicate scientific concepts /data to leadership committees both internally or externally (both written and oral) Experience with designing, monitoring, and implementing oncology clinical trials and interpreting test results in compliance with Good Clinical Practice standards and regulatory requirements Understanding of conducting study data readout activities, including data cleaning, data base lock, data extract, producing outputs of data Experience drafting high level submission documents for regulatory submissions including authoring clinical regulatory responses for health regulatory interactions Serving as a contributing author to scientific publications and data presentations at scientific conferences Experience in clinical data analysis such as Spotfire or other data analysis tools 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, well 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 Apply now 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. 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.