Medical Sciences Director - Small Cell Lung Cancer, Late Development

HOW MIGHT YOU DEFY IMAGINATION? If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of. Medical Sciences Director - Late Development Oncology Live What you will do Lets do this. Lets change the world. Amgen is advancing the largest Oncology pipeline in our history spanning several innovative technology platforms Bispecific T Cell Engagers (BiTEs), Bispecific Antibodies, Small Molecules across many targets and more than a dozen tumor types. We need collaborative and innovative world-class talent to ensure these molecules become medicines and reach their full potential while helping patients. To support that effort, the Oncology Late Development Group is looking for a Medical Sciences Director. In this vital role, the Medical Sciences Director will contribute to late phase clinical development of oncology. They will collaborate on teams to define, design, and deliver late phase clinical results, supplemented by translational projects in the ongoing strategy for drug development. Through their role, the Medical Director provides subject matter expertise in clinical and translational trial science as well as the biology and treatment of cancer. They will contribute intellectual insight into experimental design and data analysis. Serve as an internal clinical expert in translational and clinical oncology Support medical monitor in clinical trials and assist in resolving issues that may arise Present information internally and externally, anticipating and actively managing problems across a broad spectrum of cross-functional teams Provide guidance and assistance in the identification and management of oncology collaborators, consultants, and/or Clinical Research Organizations (CROs) in completion of key projects Work cross functionally to ensure clinical strategy is translated into the development of the study concept document, study protocol and related documents. Ensure integrity of protocols and/or components of clinical plans and for the delivery of final protocol and its governance approval. Provide clinical input into & implementation of clinical trial(s), their delivery, clinical data review, interpretation of results. Review and analyze clinical trial data to ensure accuracy, completeness and adherence to protocol and regulatory requirements Conduct thorough data quality assessments in the context of a data monitoring plan to maintain high standards of data accuracy and integrity throughout the trial lifecycle What we expect of you We are all different, yet we all use our unique contributions to serve patients. The medical professional we seek is a leader with these qualifications. Basic Qualifications: Doctorate degree and 4 years of life sciences/healthcare experience Or Masters degree and 7 years of life sciences/healthcare experience Or Bachelors degree and 9 years of life sciences/healthcare experience Preferred Qualifications: 5 years of pharmaceutical clinical drug development experience Strong preference for individuals with proven track record of thoracic oncology clinical trial process improvement Industry or academic experience in late-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 Thrive What you can expect of us As we work to develop treatments that take care of others, we also work to care for our teammates professional and personal growth and well-being. In addition to the base salary, Amgen offers a Total Rewards Plan comprising 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 including: 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 and bi-annual company-wide shutdowns Flexible work models, including remote 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 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. Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. 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.