Clinical Scientist Director Late Development, Rare Disease

Career Category

Job Description

CLINICAL SCIENTIST DIRECTOR - LATE DEVELOPMENT RARE DISEASE

LIVE

WHAT YOU WILL DO

Lets do this. Lets change the 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.

Key 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.
• 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 in the identification and management of 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) 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.

WIN

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.

Minimum Requirements:

• 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 Requirements:

• 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 the Rare Disease therapeutic area
• Strong communication & presentation skills in English 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 Rare Disease 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

THRIVE

WHAT YOU CAN EXPECT OF US

As we work to develop treatments that take care of others we also care deeply for our teammates well-being and growth.

• Vast opportunities to learn develop and move up and across our global organization.

• Diverse and inclusive community of belonging where colleagues are empowered to bring ideas to the table take risks and act.

• Generous AMGEN Total Rewards Plan comprising healthcare finance wealth and career benefits.

• Flexible work arrangements.

Objects in your future are closer than they us.

EQUAL OPPORTUNITY STATEMENT

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 a reasonable accommodation to participate in the job application or interview process to perform crucial job functions and to receive other benefits and privileges of employment. Please contact us to request an accommodation.