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Medical Sciences Director - Late Development, Sotorasib (Newbury Park)

Medical Sciences Director - Late Development, Sotorasib (Newbury Park)

AmgenNewbury Park, CA, United States
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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 missionto serve patients living with serious illnessesdrives 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.

Medical Sciences Director - Late Development, Sotorasib

What You Will Do

Let's do this. Let's change the world. In this vital role you will contribute to late phase clinical development of oncology. The Medical Science Director 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 Science Director provides subject matter expertise in clinical and translational trial science as well as the biology and treatment of cancer. The Medical Science Director supports experimental design and clinical data review in late phase clinical trials.

  • Serve as an internal clinical expert in translational and clinical oncology
  • Collaborate with medical monitor to support clinical trial level activities
  • 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 dynamic professional we seek is a leader with these qualifications.

Basic Qualifications :

Doctorate degree and 4 years of life sciences / healthcare experience

OR

Master's degree and 7 years of life sciences / healthcare experience

OR

Bachelor's 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 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
  • 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, 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.

    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 And Make A Lasting Impact With The Amgen Team

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    Medical Director • Newbury Park, CA, United States

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