Lead Local Operations Manager - Solid Tumor Oncology (1 of 2 Openings)

Johnson & Johnson Innovative MedicineSpring House, PA
Remote

About The Position

This role is for a Lead Local Operations Manager within the Solid Tumor Oncology division at Johnson & Johnson's Innovative Medicine unit. The position is based remotely in the United States. The Lead LOM is a senior operational leader responsible for US country-level site performance, operational strategy, and end-to-end clinical trial delivery. This role acts as the US operational hub for assigned trials, coordinating Local Operations Managers, resolving complex issues, and integrating country-level operational insights into global trial planning. The Lead LOM functions as a player-coach, leading and mentoring other Local Operations Managers while also directly managing strategic or high-impact sites and programs. The core objective is to ensure strong alignment between site execution and global trial goals, driving performance against key operational metrics such as feasibility, startup, enrollment, data quality, compliance, and closeout. This position is typically assigned to key US Oncology sites, more complex trials, programs, or portfolios, and may span multiple disease areas, requiring advanced judgment, influence, and leadership for successful country-level trial delivery. The Lead LOM may represent the country's performance in global trial forums and could take on broader trial delivery leadership responsibilities as needed.

Requirements

  • A minimum of a bachelor’s degree in Life Sciences, Nursing, Pharmacy, or related scientific discipline (or equivalent experience) is required.
  • 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.

Nice To Haves

  • Advanced scientific or clinical degrees are an advantage.

Responsibilities

  • 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 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.
  • 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.

Benefits

  • medical
  • dental
  • vision
  • life insurance
  • short and long-term disability
  • business accident insurance
  • group legal insurance
  • consolidated retirement plan (pension)
  • savings plan (401(k))
  • Vacation –120 hours per calendar year
  • Sick time - 40 hours per calendar year (may vary by state)
  • 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 period
  • Volunteer Leave – 32 hours per calendar year
  • Military Spouse Time-Off – 80 hours per calendar year
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