You have opted out of job matches in .
To undo this, go to the 'Skills and Interests' section of your preferences.
Shared by 
2 days ago
Requirements and responsibilities
Join 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 with’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.Clinical Scientist Director – Late Development OncologyWhat you will doClinical Scientist Director will support late-phase clinical development by translating scientific and clinical strategy into actionable execution across clinical trials. The Clinical Scientist serves as a key clinical development team member, providing hands-on oversight of protocol execution, medical data review, and clinical data quality to enable high-quality, decision-ready data. The Clinical Scientist works collaboratively withulatory expectations, and Amgen quality standards.Serve as a clinical and scientific subject-matter expert for the assigned therapeutic area and disease indication, with a strong focus on protocol execution and data integrity.Contribute to medical monitoring activities and support ongoing assessment of subject-level clinical data to identify trends, risks, and emerging issues.Present information internally and externally, anticipating and actively managing problems across a broad spectrum of cross-functional teams.Provide guidance and assistance sultants, 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), delivery, clinical data review, and 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 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:Doctorate degree and 4 years of clinical development experienceORMaster’s degree and 7 years of clinical development experienceORBachelor’s degree and 9 years of clinical development experiencePreferred Qualifications:5 years of pharmaceutical clinical drug development experienceStrong preference for individuals with proven track record of clinical trial process improvementIndustry or academic experience in late-phase drug development for OncologyStrong 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 clinical trials for Oncology and interpreting test results in compliance with Good Clinical Practice standards and regulatory requirementsUnderstanding of conducting study data readout activities, including data cleaning, data base lock, data extract, producing outputs of dataExperience drafting high level submission documents for regulatory submissions including authoring clinical regulatory responses for health regulatory interactionsServing as a contributing author to scientific publications and data presentations at scientific conferencesExperience in clinical data analysis such as Spotfire or other data analysis toolsWhat you can expect of usAs 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.en 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 accountsA discretionary annual bonus program, or for field sales representatives, a sales-based incentive planStock-based long-term incentivesAward-winning time-off plansFlexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.Application deadlineAmgen 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.SponsorshipSponsorship 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,