- Representing Clinical Development as a core team member on the Clinical Trial Team
- Providing a clinical review of study-specific documentation and training materials
- Performing clinical data reviews
- Assessing reported protocol deviations
- Ensuring resolution of identified issues during clinical data and protocol deviation reviews cross-functionally and with Investigational sites in collaboration with the Clinical Trial Team
- Relevant science degree (e.g., MD, PharmD, PhD); Scientific knowledge and experience in the relevant Therapeutic Area preferred
- Minimum 3 years of relevant experience or equivalent combination of experience and education.
- Ability to travel up to at least 30% of time, including international travel
- Teamwork:
- Understands cross-functional roles & responsibilities to effectively & efficiently accomplish team goals
- Takes initiative to contribute clinically relevant scientific ideas and knowledge to team globally
- Participates in team activities
- Actively listens
- Understands and leverages cross-functional roles and responsibilities
- Ability to adapt to change in project and team strategy
- Influential Communication
- Uses facts and data to validate own position
- Influences through reason
- Actively seeks to understand other perspectives
- Articulates business impact
- Matches communication to audience
- Ability to build consensus
- Communicates effectively with internal/external stakeholders
- Encourages ideas from others
- Ability to explain complex issues
- Strategic Thinking
- Ability to make connections between organization, team, product, ideas, etc.
- Ability to understand implications of strategic decisions
- Seeks more knowledge of industry, competitors
- Welcomes change
- Encourages innovation and efficiency
- Execution and Accountability
- Identifies and resolves complex problems in a solution oriented manner
- Delegates to team and keeps them focused, as applicable
- Identifies and implements best practices
- Identifies and drives priorities
- Takes charge of removing obstacles to project as appropriate with the team
- Ability to work on and communicate solutions, even in the case of unpopular business needs
- Meets corporate timelines
- Ability to make tough decisions quickly
- Global Mind Set
- Demonstrates basic understanding of global pharmaceutical/ device product development environment
- Builds relationships with global colleagues
- Demonstrates understanding and respect for cultural differences and needs
- Inclusive in interaction with others
- Embraces diversity of thoughts, ideas, and approaches
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Manager, Clinical Development/Clinical Scientist I - Irvine, United States - AbbVie, Inc
Description
Company DescriptionAt Allergan Aesthetics, an AbbVie company, we develop, manufacture, and market a portfolio of leading aesthetics brands and products. Our aesthetics portfolio includes facial injectables, body contouring, plastics, skin care, and more.
Our goal is to consistently provide our customers with innovation, education, exceptional service, and a commitment to excellence, all with a personal touch.
For more information, visit Follow Allergan Aesthetics on LinkedIn.Job Description
Description - External
The CS is responsible and accountable for the scientific/clinical implementation of the
Clinical Development Plan at the Clinical Trial Team level. The CS supports the CPL and
CSL in the development of the Clinical Development Plan and associated clinical trial
content (e.g., protocols, IBs/IDFUs, CRFs, CSRs, regulatory submissions and publications)
by contributing to scientific/clinical information aligned with the strategy. The CS is the
key Clinical Development contact for the Clinical Trial Team and is responsible for:
at internal or external meetings (e.g., with Regulatory Authorities, meetings with external experts).
Qualifications
Qualifications :
Minimum Requirements
Essential Skills & Abilities:
Applicable only to applicants
Manager, Clinical Development/Clinical Scientist I professionals in Irvine
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John Kemp
Director Technology
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Gale Acabal
Project Manager
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Jayant Kamanna
Recent Finance Graduate