Associate Director, Clinical Project Scientist

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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 Immunology
Our 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 Scientist
Purpose: 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.
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers , internal employees contact AskGS to be directed to your accommodation resource.
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Required Skills:
Preferred Skills: