Associate Director, Clinical Project Scientist

6120-Janssen Scientific Affairs, LLC Legal Entity; Horsham (PA); Vor Ort; USD 180.000 - 230.000; Vollzeit

Zusammenfassung

Johnson & Johnson Immunology is seeking an Associate Director, Clinical Project Scientist to lead IIS and company-sponsored trials within the US Medical Affairs Immunology Clinical Operations & Program Management Team. You will drive protocol development, budgeting, and cross-functional collaboration with clinical, R&D, and QA partners to ensure timely trial execution.

The role requires at least eight years in the industry and four years in clinical trial project management, with a preference

Qualifikationen

• Eight+ years of industry experience with four+ years in clinical trial project management and IIS oversight.
• Experience working in a matrix environment with risk assessment, mitigation, and contingency planning.
• Post-graduate degree in Life Sciences or Business Management preferred.
• Knowledge of immunology and global drug development processes.
• Strong time management and multi-project leadership abilities.

Aufgaben

• Contribute to protocol planning, CRFs, and study budgeting and tracking.
• Lead IIS proposal intake, review, and tracking with GD PADU partners.
• Coordinate Steering Committees, DSMBs, and Investigator Meetings.
• Develop strategic IIS guidance documents and cross-functional collaboration.
• Manage budgets, SOP adherence, and regulatory documentation across trials.
• Communicate findings through internal and external presentations.

Kenntnisse

Project management

Risk assessment

Leadership

Communication

Clinical trials

Ausbildung

Life Sciences degree

Post-graduate degree preferred

Jobbeschreibung

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.Learn more at jnj.com. As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

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.

Purpose

We are searching for the best talent for Associate Director, Clinical Project Scientist. 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.

Responsibilities

• 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

• 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

• 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.

Equal Opportunity Employer

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.

Required Skills

Preferred Skills: At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.Learn more at https://www.jnj.com/.