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About the Role

The Associate Director, Clinical Project Scientist is responsible for the implementation of Investigator Initiated Study(ies) (IIS), collaborative group study(ies), and company sponsored studies (CSS), including both interventional and registry studies. This role requires collaboration with US Medical Affairs Oncology staff and Global Development partners to review proposals and execute, track, manage, and oversee approved protocols. The focus is on ensuring timely and compliant execution to deliver data supporting evidence generation needs in the US.

Responsibilities

Oversees and supports all aspects of internal review and approval of IIS, collaborative clinical studies and company sponsored studies.
May oversee and support other medical affairs activities, such as data safety monitoring board, investigator meetings and steering committees.
Collaborates with Investigators/staff, Medical Directors/SRP/SRS, GD and other business related colleagues to build relationships for timely execution of studies.
Actively contributes to protocol/Informed consent planning and development.
Collaborates with TA lead, Medical Directors and counterpart in Global Medical Affairs to understand asset strategy and data generation priorities.
May include interpretation of results and preparation and/or review of internal/external presentations.
Manages monthly/periodic meetings to monitor/ track ongoing status of assigned studies.
May assist in IIS/collaborative proposal intake, review, and tracking.
Collaborates with medical/GD personnel to assist with execution of clinical studies.
Assists with interpretation of results; preparation of oral and written internal/external presentations.
Assists with development, management, and tracking of trial budgets.
Assists with budget and contract development with Investigators and third-party vendors.
Proactively interfaces with internal and external stakeholders to resolve contract/budget negotiation issues.
Develops and implements risk mitigation strategies.
Manages study timelines.
Assists with tracking and managing adverse event data collection across trials.
Assists with incorporation of adverse event data into obligatory regulatory documents.
Interfaces with GCO Safety personnel and Global Medical Safety.
Executes and/or oversees franchise clinical initiatives (program quality, tracking against financial targets, timelines, clinical processes, etc).
May lead cross-functional teams for evaluating new product ideas, implementing franchise business strategies, and/or developing and monitoring strategies for clinical process effectiveness.
Ensures compliance with internal J&J SOPs including local and global health authority regulations and guidelines.

Requirements

A minimum of a Bachelor's Degree is required.
A minimum of 7 years of experience within the pharmaceutical industry is required.
Significant experience in supporting, overseeing or managing IIS/collaborative trials and/or company sponsored studies is required.
Proven presentation and analytical skills are required.
Ability to work efficiently and lead cross functional teams is required.
Able to think creatively, critically, and proactively, with strong problem-solving skills.
Collaborative and flexible in personal interactions at all levels of the company.

Skills

Agile Decision Making
Agility Jumps
Analytics Insights
Business Alignment
Continuous Improvement
Cross-Functional Collaboration
Leadership
Organizational Project Management
Organizing
Program Management
Project Management Methodology (PMM)
Project Management Office (PMO)
Project Management Tools
Project Reporting
Statement of Work (SOW)
Technical Credibility

Location

Horsham, Pennsylvania, United States of America
New Jersey (Any City)
New York (Any City)

Work Type

Onsite

Experience Level

Associate Director

Education Level

Bachelor's Degree
Advanced degree preferred

Salary/Compensations

$122,000.00 - $212,750.00

Benefits

Annual performance bonus
Medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
Consolidated retirement plan (pension) and savings plan (401(k)).
Long-term incentive program.
Vacation – up to 120 hours per calendar year
Sick time - up to 40 hours per calendar year (up to 56 hours for Washington State residents)
Holiday pay, including Floating Holidays – up to 13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year

About the Company

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevention, treated, and cured, where treatments are smarter and less invasive, and solutions 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.
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 Oncology team is focused on the elimination of cancer by discovering new pathways and modalities to finding treatments and cures.
We lead where medicine is going and need innovators with an unwavering commitment to results.
Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Equal Opportunity

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 and 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, please email the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.