Manager, Clinical Operations, Early Development, Oncology

Johnson Johnson; Spring House (PA); Remote; USD 120,000 - 160,000; Full time

Job summary

Johnson & Johnson is seeking a Manager of Clinical Operations in Early Development, Oncology, to lead the team and ensure strategic execution of ED&CP trials. The role involves managing Trial Managers, Site Managers, and CTAs, while aligning with regulatory and corporate goals.

You will drive staffing, training, and process improvements across the ED&CP organization in the US, with a focus on performance and delivery for oncology programs.

Qualifications

• Experience leading clinical operations teams in early development.
• Ability to forecast resources and manage timelines and budgets.
• Experience coordinating with ethics committees and health authorities.

Responsibilities

• Provide line management to direct reports including goals and evaluation.
• Forecast resource needs for the portfolio and collaborate with directors.
• Support hiring, onboarding, and staff development activities.
• Ensure training compliance and alignment with SOPs and policies.
• Coordinate with ethics committees, authorities, sites, and study teams.

Skills

Line management

Resource forecasting

Stakeholder management

Hiring & onboarding

Budget oversight

Staff development

Job description

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, 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. Learn more at jnj.com

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function

R&D Operations

Job Sub Function

Clinical Trial Project Management

Job Category

People Leader

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

We are searching for the best talent for Manager, Clinical Operations, Early Development, Oncology to be remote in the US.

Purpose

The Manager Clinical Operations for Early Development is accountable for strategic and operational management and successful country execution of early development and/or clinical pharmacology (ED&CP, phase 0-IIa) trials across multiple therapeutic areas, including resource allocation, adherence to timelines and budget, compliance with relevant SOPs, policies, Health Care Compliance, and local regulatory requirements. The FM early development is accountable for shaping and managing local and regional organizational ED&CP structure to ensure its optimal efficiency and demonstrates an effective issue management.

This individual is responsible for line management of Trial Managers (TMs) Early Development, Site Managers (SMs) Early Development, Clinical Trial Assistants (CTAs) and/or other GCO staff as required. Oversees staff performance, development, training, project assignments, workload distribution and supports issue resolution with direct reports. Ensures alignment of local goals with organizational objectives.

Drives innovative solutions and process improvements for ED&CP and GCO/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 area of responsibility, as required and agreed with the Director Early development EMEA/Americas.
• Support the flexible resourcing model and collaborate with Flex Resource managers to hire qualified staff in a timely manner, provide feedback on flex staff performance and support their on-boarding and off-boarding.
• Interview, hire, develop and train staff.
• Ensure understanding of relevant processes and procedural documents supported by documentation of direct reports' training compliance, as required.
• Support direct reports in issue resolution and communication with different stakeholders like Ethics Committees, Health Authorities, Investigational Sites, and study management team.
• Support local implementation of organizational changes and effectively communicate on priority shifts.
• Review and approve expenses in compliance with the company policies.
• Demonstrate leadership behaviors in alignment with J&J 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 and execute long term strategy in alignment with GD, EDCP, and JJIM R&D strategies to position the local and regional EDCP organization for success.
• Accountable for attracting, planning