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Program Manager, Clinical Development (Clinical Scientist)

New Jersey All, NJ

Job Type: Clinical Job Number: JN -012020-26189 Region: New Jersey All

Job Description

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

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 6 years of overall Clinical Research experience

At least 4 years of Clinical Scientist experience in the pharmaceutical/device industry

Ability to travel up to at least 10% of time, including international travel

Essential Skills & Abilities:

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

Actively influences others without a direct reporting relationship

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

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

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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