Clinical Project Scientist - Immunology

Clinical Project Scientist

Department: Immunology US Medical Affairs

Job Location: Horsham, PA

In Office Requirement

Monday Tuesday & Wednesday in office in Horsham (Thursday & Friday Remote)

Leading Pharmaceutical Company located in NJ is hiring a Clinical Project Scientist - Immunology w/5 years industry experience. If you want to be a part of this groundbreaking work, please apply!

Job Summary

This individual contributor will be a part of the US Medical Affairs Immunology Clinical Operations & Program Management Team and support one to two therapeutic areas. The Clinical Project Scientist is responsible for successful implementation of the Investigator Initiated Study (IIS) program as well as company sponsored trials, collaborative studies and post marketing commitment studies, including both interventional, non-interventional and registry studies. In this role, the individual will work closely with the Therapeutic Area Lead, the Medical Directors (Study Responsible Physicians) responsible for individual assets, the Medical Science Liaison (MSL) team, and Global Development Medical Affairs Delivery Unit (GD MADU) to review submitted IIS proposals and execute, track, manage and oversee approved IIS protocols. He/she will work with the Medical Directors, MSL team, and GD MADU to ensure that IIS trials are executed in a timely and compliant fashion to deliver data to support evidence generation needs in the US.

This individual will also work closely with the Study Responsible Physicians and Research Scientists for US Medical Affairs sponsored studies, to ensure that these company sponsored studies and collaborative studies are conducted and executed in a timely manner. A key responsibility will be review and coordination of all project-related documentation, leading the Steering Committee process with SRPs, completing user acceptance testing of systems and leading Lessons Learned Meetings. As a leader on the Study Team, this individual will identify issues and potential operational hurdles within a project and propose options for resolution in coordination with the Study Responsibility Physician, Study Responsible Scientist and Global Trial Leader(s). This individual is the main point of contact for GD MADU for studies.

Key Responsibilities

Clinical Project Scientist Lead for assigned company sponsored, collaborative, post marketing and registry Trials including but not limited to:

• Actively contribute to protocol planning and development and case report forms
• Prepare agendas and meeting minutes for study meetings and lessons learned meetings
• Review study plans and provide feedback to GD MADU
• Develop study trackers (i.e., enrollment tracker, Steering Committee tracker)
• Assist with user acceptable testing for clinical trial systems
• Prepare presentations and reports for leadership
• Assist with budget management as requested
• Issue identification and resolution and proactive risk mitigation
• Lead the preparation and scheduling of Steering Committees, Data Safety Monitoring Boards and Investigator Meetings under oversight of the SRPs
• Key liaison (primary point of contact) with our GD MADU partners and other scientific and business-related disciplines (e.g., R&D, Clinical Supplies, QA, etc.)
• In concert with medical/clinical personnel, the Clinical Project Scientist assists with execution of clinical studies; interpretation of results; preparation of oral and written internal/external presentations; development, management, and tracking of trial budgets; and budget and contract development with third party vendors
• Assist with tracking and managing adverse event data collection across trials; and where appropriate, incorporation into obligatory regulatory documents
  
  

Required Qualifications

• Previous work with international and multidisciplinary drug development teams with knowledge of regulatory requirements and industry standards
• Exhibits strong analytical skills for integrating and interpreting complex scientific and project information
• Strong interpersonal skills for bridging scientific and business perspectives with the ability to negotiate timelines and deliverables between various levels within the organization
• Repeated demonstration of the ability to resolve conflict, influence teams, and build relationships in meeting organizational objectives without formal authority
• Solid problem-solving skills developing creative solutions to maintain project timelines; ability to resolve conflicts in an objective fashion
• Strong planning and tracking skills, capable of managing multiple projects, excellent time management with respect to priorities and self-management.
• Financial acumen and study budget forecasting
• Previous contract management/negotiation experience required
• Core competencies to include delivery of results, gaining commitment, interdependent partnering, building trust, decision making, risk mitigation and communications