Job Function: Medical Affairs Group
Job Sub Function: Medical Affairs
Job Category:Scientific/Technology
All Job Posting Locations:Horsham, Pennsylvania, United States of America
Job Description:About ImmunologyOur expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Our Immunology team leads in the development of transformational medicines for immunological disorders and illnesses. You can influence where medicine is going by restoring health to millions of people living with immune diseases.
Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.
Learn more at https://www.jnj.com/innovative-medicine
An internal pre-identified candidate for consideration has been identified. However, all applications will be considered.
We are searching for the best talent for
Associate Director, Clinical Project ScientistPurpose: 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 Associate Director, 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.
You will be responsible for:- 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 PADU
- 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 PADU 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:- Collaborates with TA lead, Medical Directors and counterparts in GD PADU 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
Clinical Project Scientist Lead for Process Improvements/TA Priorities including but not limited to:- Improve execution of IIS program and company-sponsored research through clinical initiatives to improve efficiency (program quality, tracking against financial targets, metrics/ timelines). Initiatives will include support of advisory boards, investigator meetings, data safety monitoring boards (DSMB), clinical division meetings, business plan & strategic plan process, management of internal and external registries
- Lead cross-functional teams for evaluating new product ideas, implementing franchise business strategies, and/or developing and monitoring strategies for clinical process effectiveness
- Oversee franchise clinical initiatives (program quality, tracking against financial targets, timelines, clinical processes, etc.) in collaboration with TA leadership
Qualifications / Requirements:- At least eight years of industry experience, including a minimum of four years of clinical trial project management and operations experience in Phase II-IV clinical trials, with oversight of and accountability for IIS research.
- Proven ability to work effectively in a matrix environment, with experience in risk assessment, mitigation, and contingency planning.
- Post-graduate degree in Life Sciences or Business Management preferred.
- Preferred Area of Study: Life Sciences and/or Business Management.
- Preferred Knowledge, Skills, and Abilities (including computer skills, certifications, licenses, and languages):
- Detailed knowledge of the basic science of Immunology and drug development.
- Expert knowledge of the global drug development process.
- Strong ability to manage multiple projects, with excellent time management, prioritization, and self-management skills.
- Previous people leadership experience within Clinical Operations and/or Clinical Trial Management.
#LI-Hybrid
Required Skills: Preferred Skills: 
