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**Job Function: **
R&D Operations
**Job Sub Function: **
Clinical Trial Support
Job Category:
Professional
All Job Posting Locations:
Spring House, Pennsylvania, United States of America, Titusville, New Jersey, United States of America
Job Description:
About Innovative Medicine:
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.
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
**We are searching for the best talent for an **Associate Director, Clinical Operations - Study Start-up, US Oncology in Spring House, PA or Titusville, NJ.
Remote work options may be considered on a case-by-case basis and if approved by the Company.
Purpose:
The Associate Director, Clinical Operations - Study Start-up, US Oncology will be accountable for the operational management and successful country execution of all phases of clinical trials within the assigned therapeutic area(s), or specific role(s), including resource allocation, adherence to timelines and budget, compliance with relevant Standard Operating Procedures (SOPs), policies, Health Care Compliance (HCC) and local regulatory requirements. The Associate Director will support the Country Head in shaping and managing local organizational structure to ensure its optimal efficiency.
This individual will be responsible for line management of Local Trial Managers (LTMs), Site Managers (SMs), Clinical Trial Assistants (CTA) and/or other DU staff (including Manager, Clinical Operations), as required. May also mentor less experienced Functional Managers (FM)/Clinical Research Managers (CRM) and assume cross-border oversight, if required. Oversee staff performance, development, training, project assignments, workload distribution and support issue resolution with direct reports. Ensure alignment of local goals with organizational objectives. Drive innovative solutions and process improvements for the assigned therapeutic area(s), country, and DU/Global Development (GD) overall.
You will be responsible for:
- Provide line management to direct reports, including setting goals and objectives, performance evaluation and talent development.
- Evaluate and forecast resource needs for assigned portfolio and/or other specific areas of responsibility, as required and agreed with local DU management accordingly.
- Deployment of the One Delivery Model through collaboration and oversight of vendors.
- Accountable for the acquisition of new talents and development of human resources.
- Guide direct reports in issue resolution and communication with involved stakeholders.
- Lead organizational changes and effectively communicate on priority shifts as required.
- Review and approve expenses in compliance with the company policies.
- Demonstrate leadership behaviors in alignment with Johnson & Johnson Leadership Imperatives.
- Foster an environment that encourages sharing of ideas, information and best practices (internal and external to the organization).
- Provide coaching and mentorship as needed, including conduct of accompanied site visits as appropriate.
- Define, execute or support long-term strategy in alignment with DU, GD and Johnson & Johnson Innovative Medicine (JJIM) R&D strategies to position the local and global DU organization for success.
- Oversight of execution and monitoring of clinical trials through all phases (from feasibility to close-out) and ensuring inspection-readiness within assigned therapeutic area(s) and/or other areas of responsibility, as required.
- Accountable for ensuring relevant operational objectives are met in conformance to International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use - Good Clinical Practice (ICH-GCP), relevant SOPs and other procedural documents.
- Accountable for appropriate and timely issue escalation and reporting (suspicion) of fraud, scientific/ethical misconduct and health care compliance breach.
- Contribute to Corrective and Preventative Action (CAPA) and issue resolution in accordance with required timelines.
- Shape and maintain strong relationships within local DU department and Local Operating Company (particularly with Medical Affairs) and other key internal and external stakeholders.
- Develop country capabilities for an effective study placement within assigned therapeutic area(s) and/or other areas of responsibility, as required.
- Accountable for robust feasibility process and oversight of site selection to deliver on country commitments within assigned therapeutic area(s) and strategic goals.
- Review operational and quality metrics regularly and drive follow-up actions as appropriate.
- Drive innovative solutions and process improvements for the assigned therapeutic area(s), country, and DU/GD overall. Foster a culture of continuous improvement and innovation within the local DU team.
Qualifications / Requirements:
Education:
- Minimum of a Bachelor's degree is required, preferably in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy)
**Required: **
- Minimum of 8 years of clinical research experience within the pharmaceutical industry, Contract Research Organization (CRO) and/or investigational site
- People management experience
- Knowledge of the drug development process, clinical research operations and regulatory requirements, including ICH-GCP, Health Care Compliance (HCC) and applicable regulations
- Financial management skills (e.g., budgeting, forecasting, risk analysis, etc.)
- Must have excellent communication, interpersonal and leadership skills, with the proven ability to foster team productivity and cohesiveness
- Must have strong decision-making, issue resolution and negotiating skills
- Must have flexibility to work in a fast-changing environment and operate under limited supervision
- The ability to evaluate data generated from various reports and sources
- The ability to effectively communicate with various internal and external stakeholders (e.g., investigational sites, ethics committees, health authorities, etc.)
- The ability to collaborate with all levels of management and handle multiple priorities within a matrix environment
- This position will require up to 10% travel, primarily for meetings and conferences
Preferred:
- Experience in the Oncology (Solid Tumor and/or Hematology) Therapeutic Area
- Experience managing direct reports
The anticipated base pay range for this position in the US is $137,000 to $235,750.
The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis.
Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short and long-term disability, business accident insurance, and group legal insurance.
Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
This position is eligible to participate in the Company’s long-term incentive program.
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
- Vacation –120 hours per calendar year
- Sick time - Sick time - 40 hours per calendar year; for employees who reside in the State of Washington – 56 hours per calendar year
- Holiday pay, including Floating Holidays –13 days per calendar year
- Work, Personal and Family Time - up to 40 hours per calendar year
- Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
- Condolence Leave – 30 days for an immediate family member: 5 days for an extended family member
- Caregiver Leave – 10 days
- Volunteer Leave – 4 days
- Military Spouse Time-Off – 80 hours
For additional general information on company benefits, please go to: https://www.careers.jnj.com/employee-benefits
This job posting is anticipated to close on May 28, 2026. The Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications.
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.
#LI-Hybrid
Required Skills:
Preferred Skills:
The anticipated base pay range for this position is :
$137,000.00 - $235,750.00
Additional Description for Pay Transparency:
Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
This position is eligible to participate in the Company’s long-term incentive program.
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
Holiday pay, including Floating Holidays –13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period10 days
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year
For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits