Lead, Local Operations Manager – Solid Tumor Oncology

This is a fully remote position, open to applicants in New Jersey.

📋 Description

• Take ownership of operational delivery at the US site level for designated sites.

• Lead and coordinate activities of the local trial team in accordance with SOPs, procedural documents, and relevant regulations.

• Spearhead local project planning to achieve recruitment goals and ensure timely delivery of high-quality data within budget constraints.

• Create local trial-specific procedures and tools.

• Oversee recruitment planning, contingency and risk management, as well as budget forecasting.

• Provide leadership, oversight, and mentoring to Local Operations Managers involved in the trial or program.

• Formulate the US trial operational strategy and incorporate site insights into global feasibility and startup planning.

• Act as the primary operational interface for the US with global trial leadership.

• Track country-level operational KPIs, identifying systemic risks and strategies for mitigation.

• Serve as the point of escalation for intricate site contracting, operational, and recruitment challenges.

• Represent US local operations at investigator or study coordinator meetings and governance forums.

• Act as a subject matter expert for assigned protocols, enhancing therapeutic knowledge.

• Represent Oncology Site Enablement on cross-functional teams when applicable.

• Elevate insights from US sites to inform global decision-making and foster continuous improvement.

• Assume additional responsibilities or special initiatives, including Champion or Subject Matter Expert roles.

• Represent the functional area or lead the country, Delivery Unit, and global process initiatives as necessary.

• Travel is required, approximately 10% of the time.

⛳️ Requirements

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

• At least 4 years of experience in clinical trial operations, trial management, site management, or clinical monitoring.

• Significant experience in managing complex, high-priority, or multi-site trials.

• Strong preference for demonstrated experience in oncology trial operations.

• Comprehensive understanding of the clinical development process and end-to-end trial delivery.

• Proven expertise in feasibility, startup strategy, enrollment execution, quality oversight, and trial closeout.

• Strong knowledge of GCP, regulatory requirements, inspection readiness, and compliance management.

• Experience in supporting audits and regulatory inspections.

• Leadership experience in coaching, mentoring, and guiding Local Operations Managers or site-facing roles.

• Ability to lead through influence, resolve escalations, and ensure alignment across cross-functional and global trial teams.

• Experience with country-level or trial-level operational strategies, site selection, enrollment forecasting, and risk mitigation planning.

• Excellent analytical skills for interpreting country- and site-level KPIs, identifying systemic risks, and implementing corrective measures.

• Exceptional written and verbal communication skills in both the local country language and English.

• Willingness to travel up to 10%, including overnight stays and attendance at investigator and governance meetings.

• Flexibility, resilience, and the ability to thrive in a complex, rapidly changing clinical development environment.

🏝️ Benefits

• Consolidated retirement plan (pension).

• Savings plan (401(k)).

• Long-term incentive program.

• Vacation – 120 hours per calendar year.

• Sick time – 40 hours per calendar year; 48 hours per calendar year for employees residing in Colorado; 56 hours per calendar year for employees residing in Washington.

• 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.

• Inclusive interview process and disability accommodations.