Clinical Project Scientist

Clinical Project Scientist

Hybrid - Onsite in Horsham, PA Monday - Wednesday (Thursday & Friday Remote)

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.

Interfaces with multiple scientific partners related to planning and strategy for therapeutic area trials and publication strategy. Interfaces with insourced and outsourced trial execution resources within the GD MADU organization. Considered by peers as a clinical trials expert, technically proficient, intelligent, and results oriented. Able to think creatively, critically, and proactively, with strong problem-solving skills. Collaborative and flexible personal interactions at all levels of the company. This individual will interface regularly with both internal and external stakeholders and vendors.

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

Clinical Project Scientist Lead for TA IIS program including but not limited to:

• Collaborate with TA lead, Medical Directors and counterparts in GD MADU to develop strategic IIS guidance documents and support IIS projects across the portfolio
• Serve as the primary liaison between J&J Innovative Medicine and Clinical Investigators
• Manages monthly/periodic meetings to monitor and update organizational logistics of IIS proposal intake, review, and tracking
• Actively review and provide feedback per SOPs for protocols and Informed Consents

Required Qualifications:

• Minimum 5 years' experience
• Bachelor's degree required
• 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.
• Proficiency in Microsoft Office and Teams
• 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

Preferred Qualifications:

• Detailed knowledge of the basic science of Immunology drug development.
• Expert knowledge of the global drug development process.
• Ability to manage multiple projects, including excellent time management with respect to priorities and self-management.

Systems Utilized:

• ARAVO
• EMP (EMarketplace)
• Totality
• Ask GS
• Veeva Vault
• Totality
• RAVE
• IWRS