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Senior Manager, Clinical Development (Clinical Scientist)

New Jersey All, NJ

Posted: 03/07/2019 Job Type: Clinical Job Number: JN -032019-23879
  • The Senior Manager, Clinical Development may have global or regional responsibilities and is expected to fulfil the Clinical Scientist (CS) role within the Gastroenterology Therapeutic Area
  • 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 Clinical Program Lead (CPL) and Clinical Science Lead (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:
    • 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
  • The CS may present the clinical development aspects of a project and clinical trial results at internal meetings
Minimum Requirements:
  • Relevant science degree (e.g., MD, PharmD, PhD); Scientific knowledge and experience in the relevant Therapeutic Area preferred
  • At least 4 to 6 years of Clinical Science experience in the pharmaceutical/device industry
  • Ability to travel up to at least 10% of time, including international travel
Essential Skills & Abilities:
  • 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
  • Understands and leverages cross-functional roles and responsibilities
  • Ability to adapt to change in project and team strategy
  • 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
  • Actively influences others without a direct reporting relationship
  • 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
  • Identifies and resolves complex problems
  • 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
  • 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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