Lead Local Operations Manager - Solid Tumor Oncology

6084-Janssen Research & Development, LLC Legal Entity; Spring House (PA); Hybrid; USD 109,000 - 175,000; Full time

Job summary

Johnson & Johnson's Innovative Medicine division in the United States seeks a Lead Local Operations Manager to oversee US site-level delivery across the end-to-end clinical trial lifecycle, coordinating Local Operations Managers and aligning country plans with global trial objectives.

You will mentor teams, shape local trial strategy, drive feasibility, startup, enrollment, data quality and compliance, and serve as the primary US interface to global leadership.

Qualifications

• Bachelor’s degree in Life Sciences, Nursing, Pharmacy, or related field; advanced degrees are a plus.
• Minimum 4 years of clinical trial operations or trial management experience.
• Experience in oncology trial operations strongly preferred.
• Deep understanding of end-to-end trial delivery and regulatory compliance.
• Leadership experience coaching Local Operations Managers or site staff.

Responsibilities

• Owns US site level operational delivery for assigned sites.
• Leads local trial team activities in compliance with SOPs, other procedural documents, and applicable regulations.
• Leads local project planning activities to meet recruitment targets and to deliver high quality data on time and within study budget, including development of local procedures and tools, recruitment planning, risk management, and budget forecasting.
• Provides leadership oversight and mentoring support to other local operations managers on the trial or program.
• Shapes US trial operational strategy and integrates site insights into global feasibility and startup planning.
• Represents US local operations at investigator and study coordinator meetings and key governance forums.
• Acts as subject matter expert for assigned protocols and develops therapeutic knowledge to support roles and responsibilities.
• May represent Oncology Site Enablement on cross functional teams.
• Elevates US site insights to inform global decision-making and continuous improvement.
• 10% travel is expected.

Skills

Analytical Reasoning

Clinical Research

Regulations

CTMS

Clinical Trials

Communication

Data Savvy

Laboratory Operations

Organizing

Problem Solving

Quality Assurance

Regulatory Compliance

Research and Development

SOP

Education

Bachelor's degree in Life Sciences

Tools

CTMS

Job description

Job Function:

R&D Operations

Job Sub Function:

Clinical Trial Project Management

Job Category:

Professional

All Job Posting Locations:

Remote (US), Spring House, Pennsylvania, 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

About Oncology

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. Learn more at https://www.jnj.com/innovative-medicine

Purpose:

The Lead Local Operations Manager (LOM) is a senior operational leader accountable for US country level site performance, operational strategy, and delivery across the end-to-end clinical trial lifecycle. The Lead LOM serves as the US operational nexus for assigned trials, coordinating Local Operations Managers, resolving complex escalations, and integrating country level operational insights into global trial planning and execution. Operating as a player coach, the Lead LOM leads and mentors other Local Operations Managers while directly managing strategic or high impact sites and programs. The role ensures strong alignment between site level execution and global trial objectives, driving delivery against key operational KPIs related to feasibility, startup, enrollment, data quality, compliance, and closeout. Compared with Associate and Senior Local Operations Manager roles, the Lead LOM is typically assigned to key USA Oncology sites, more complex trials, programs, or portfolios, may work across multiple disease areas, and is expected to exercise advanced judgment, influence, and leadership to ensure successful country level trial delivery. The Lead LOM may represent the country’s performance for a specific trial, in global trial forums and may, where required, assume broader trial delivery leadership responsibilities in accordance with Global Development procedural documents.

You will be responsible for:

• Owns US site level operational delivery for assigned sites
• Leads and coordinates local trial team activities in compliance with SOPs, other procedural documents, and applicable regulations.
• Leads local project planning activities to meet recruitment targets and to deliver high quality data on time and within study budget, including but not limited to: development of local trials specific procedures and tools, recruitment planning, contingency and risk management, and budget forecasting.
• Provides leadership oversight and mentoring support to other local operations managers assigned to the trial or program
• Shapes US trial operational strategy and integrates site insights into global feasibility and startup planning
• Serves as the primary US operational interface to global trial leadership
• Monitors country level operational KPIs and identifies systemic risks and mitigation strategies.
• Acts as escalation point for complex site contracting, operational, and recruitment issues.
• Represents US local operations at investigator and/or study coordinator site meetings and key governance forums.
• Acts as subject matter expert for assigned protocols and develops strong therapeutic knowledge to support roles and responsibilities.
• May represent Oncology Site Enablement on cross functional teams.
• Elevates US site insights to inform global decision-making and continuous improvement.
• 10% travel is expected.
• Expected to assume additional responsibilities or special initiatives such as “Champion” or “Subject Matter Expert” and to represent the functional area or lead country, Delivery Unit, and global level process initiatives, as required.

Qualifications / Requirements:

• A minimum of a bachelor’s degree in Life Sciences, Nursing, Pharmacy, or related scientific discipline (or equivalent experience) is required; advanced scientific or clinical degrees are an advantage.
• Typically, a minimum of 4 years of experience in clinical trial operations, trial management, site management, or clinical monitoring, including significant experience in complex, high-priority, or multi-site trials.
• Demonstrated experience in oncology trial operations is strongly preferred
• In-depth understanding of the clinical development process and end-to-end trial delivery, with demonstrated expertise in feasibility, startup strategy, enrollment execution, quality oversight, and closeout.
• Strong and applied knowledge of GCP, regulatory requirements, inspection readiness, and compliance management, with experience supporting audits and regulatory inspections.
• Demonstrated leadership experience, including coaching, mentoring, and guiding other Local Operations Managers or site-facing roles in a player‑coach capacity.
• Proven ability to lead through influence, resolve escalations, and drive alignment across cross‑functional and global trial teams.
• Experience shaping or contributing to country‑level or trial‑level operational strategy, including site selection, enrollment forecasting, and risk mitigation planning.
• Strong analytical skills with the ability to interpret country‑ and site‑level KPIs, identify systemic risks, and implement corrective actions.
• Excellent written and verbal communication skills in both the local country language and English, with demonstrated ability to represent the country or region in global forums.
• Willingness to travel up to 10% as required, including overnight stays and participation in investigator meetings and key trial governance meetings.
• Demonstrated flexibility, resilience, and ability to operate effectively in a highly complex, fast‑changing clinical development environment.

Required Skills:

Analytical Reasoning, Clinical Research and Regulations, Clinical Trial Designs, Clinical Trial Management Systems (CTMS), Clinical Trials, Communication, Data Savvy, Laboratory Operations, Organizing, Problem Solving, Productivity Planning, Professional Ethics, Project Integration Management, Quality Assurance (QA), Regulatory Compliance, Research and Development, Research Ethics, Standard Operating Procedure (SOP)

Preferred Skills:

Analytical Reasoning, Clinical Research and Regulations, Clinical Trial Designs, Clinical Trial Management Systems (CTMS), Clinical Trials, Communication, Data Savvy, Laboratory Operations, Organizing, Problem Solving, Productivity Planning, Professional Ethics, Project Integration Management, Quality Assurance (QA), Regulatory Compliance, Research and Development, Research Ethics, Standard Operating Procedure (SOP)

The anticipated base pay range for this position is :

$109,000.00 - $174,800.00

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)). 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

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. If you are under 18 years of age, you (the candidate) may need to obtain the necessary working papers or other documentation required by state law to start the assignment, as well as get a parent’s consent for the background check.