Join our team atAMGEN Capability Center Portugal, number 1 company in Best WorkplacesTMhttps://www.greatplacetowork.pt/ranking in Portugal in 2024 (category 201-500 employees) by the Great Place to Work Institute. We have a team of over 500 talented people and more than 40 different nationalities, diverse areas of expertise and professional experience that are shaping the future of healthcare. This is your chance to explore a world of opportunities in different areas such as Cybersecurity, Data & Analytics, Digital, Technology and Innovation, Finance, General & Admin, Human Resources, Regulatory Affairs and many more. In Lisbon's city center, our AMGEN office fosters innovation, excellence, and inspiration. Come thrive with us at AMGEN, supporting our mission To Serve Patients. What we do at AMGEN matters in people’s lives.
CLINICAL SCIENTIST ASSOCIATE DIRECTOR - LATE DEVELOPMENT
WHAT YOU WILL DO
Let’s do this. Let’s change the world. In this role, the Clinical Scientist Associate Director supports late-phase clinical development by contributing to protocol development, study start up, data review and monitoring and analysis activities. Working collaboratively with the study team and clinical leadership, this role focuses on study-level implementation and cross-functional coordination to help ensure high-quality, decision-ready clinical data.
Key Responsibilities:
* Support set up and execution of late phase clinical trials with a focus on data quality
* Assist in authoring clinical protocols, Investigators Brochures and other regulatory documents ensuring consistency and clarity
* Provide input into & implementation of data management plan, CRF design, and data review oversight
* Support review, analysis, and presentation preparation of clinical trial data for internal decision making, external interactions, and regulatory submission
* Assist Development Lead and Medical Sciences Director in medical monitoring and management of collaborators, consultants, and/or Clinical Research Organizations in completion of key projects
* Anticipate and actively manage problems across a broad spectrum of cross-functional teams
* Work cross functionally within teams to ensure clinical strategy is translated into the development of the study concept document, study protocol and related documents
* Support appropriate training, recruitment, and development requirements for matrix team resources
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 3 years of life sciences/healthcare experience OR
* Master’s degree and 5 years of life sciences/healthcare experience OR
* Bachelor’s degree and 7 years of life sciences/healthcare experience
Preferred Requirements
* 3 years of pharmaceutical clinical drug development experience
* Demonstrated experience contributing to clinical trial process improvements within a therapeutic area or study team environment
* Industry or academic experience supporting early or late-phase drug development within a relevant therapeutic area or disease indication
* Strong communication and presentation skills in English, with the ability to clearly convey scientific concepts and clinical data to cross-functional teams and leadership audiences, both written and oral
* Experience supporting the design, monitoring, and implementation of clinical trials in compliance with Good Clinical Practice standards and applicable regulatory requirements
* Working knowledge of study data readout activities, including data cleaning, database lock, data extraction, and generation of clinical data outputs
* Experience contributing to regulatory submission documents and supporting clinical regulatory responses for health authority interactions under guidance
* Experience serving as a contributing author on scientific publications or data presentations for internal forums or scientific conferences
* Experience in clinical data analysis such as Spotfire or other data analysis tools
WHAT YOU CAN EXPECT OF US
* 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.
APPLY NOW
Objects in your future are closer than they appear. Join us.
CAREERS.AMGEN.COM
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.
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