Clinical Scientist Director, Late Development Rare Disease

Amgen • Thousand Oaks, CA

6d

About The Position

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 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. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. 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. Clinical Scientist Director What you will do Let’s do this. Let’s change the world. In this vital role, the Clinical 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 within cross-functional teams to ensure clinical trials are executed in alignment with protocol intent, regulatory expectations, and Amgen quality standards.

Requirements

• Doctorate degree and 4 years of clinical development experience OR Master’s degree and 7 years of clinical development experience OR Bachelor’s degree and 9 years of clinical development experience

Nice To Haves

• 5 years of pharmaceutical clinical drug development experience
• Strong preference for individuals with proven track record of clinical trial process improvement
• Industry or academic experience in late-phase drug development for Inflammation Development Therapeutic Area.
• 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 clinical trials for the Inflammation Development Therapeutic Area 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

Responsibilities

• 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.
• Work cross functionally to ensure clinical strategy is translated into the development of the study concept document, study protocol, and related documents
• Provide guidance and assistance in the identification and management of collaborators, consultants, and/or Clinical Research Organizations (CROs) in completion of key projects.
• 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.
• Ensure integrity of protocols and/or components of clinical plans and for the delivery of final protocol and its governance approval.
• Contribute to medical monitoring activities and support ongoing assessment of subject-level clinical data to identify trends, risks, and emerging issues.
• 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.
• Present information internally and externally, anticipating and actively managing problems across a broad spectrum of cross-functional teams.

Benefits

• 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 where possible.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: Ph.D. or professional degree