[Hiring] Manager, Clinical Operations, Early Development, Oncology @Johnson & Johnson Innovative Medicine

Role Description

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

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.
• Resource allocation, adherence to timelines and budget, compliance with relevant SOPs, policies, Health Care Compliance, and local regulatory requirements.
• Shaping and managing local and regional organizational ED&CP structure for optimal efficiency.
• Line management of Trial Managers (TMs), Site Managers (SMs), Clinical Trial Assistants (CTAs), and/or other GCO staff as required.
• Overseeing staff performance, development, training, project assignments, workload distribution, and supporting issue resolution.
• Driving innovative solutions and process improvements for ED&CP and GCO/GD overall.

You will be responsible for:

• Providing line management to direct reports including setting goals and objectives, performance evaluation, and talent development.
• Evaluating and forecasting resource needs for assigned portfolio and/or other specific area of responsibility.
• Supporting the flexible resourcing model and collaborating with Flex Resource managers.
• Interviewing, hiring, developing, and training staff.
• Ensuring understanding of relevant processes and procedural documents.
• Supporting direct reports in issue resolution and communication with stakeholders.
• Reviewing and approving expenses in compliance with company policies.
• Demonstrating leadership behaviors in alignment with J&J Leadership Imperatives.
• Fostering an environment that encourages sharing of ideas, information, and best practices.
• Providing coaching and mentorship as needed.
• Defining and executing long-term strategy in alignment with GD, ED&CP, and JJIM R&D strategies.
• Accountability for attracting, planning, execution, and monitoring of ED&CP clinical trials.
• Ensuring relevant operational objectives are met in conformance to ICH-GCP and other procedural documents.
• Accountability for appropriate and timely issue escalation and reporting.
• Shaping and maintaining strong relationships within ED&CP and other key stakeholders.
• Developing country ED&CP capabilities and collaborating for effective study placement.
• Leading regular metrics review and driving necessary follow-up actions.
• Ensuring adequate quality oversight and inspection readiness.
• Oversight of local ED&CP budget and accurate financial reporting.
• Contributing to development, evaluation, and implementation of new processes and systems.
• Fostering a culture of continuous improvement and innovation.
• Modeling Credo based culture within the local ED&CP team.

Qualifications

• Bachelor's degree or equivalent required, preferably in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy).
• Minimum of 8 years of clinical research experience in pharmaceutical industry, CRO, or investigational site.
• Demonstrated AI literacy and an AI enabled mindset.
• Effective communication and leadership skills.
• Experience in mentoring/coaching others.
• Solid decision-making and financial management skills.
• Excellent knowledge of drug development, clinical research operations, and regulatory requirements.
• Flexible mindset and ability to work in a fast-paced environment.
• Proficient in English language and computer literacy.
• Strong interpersonal and negotiating skills.
• Excellent organizational skills and ability to handle multiple priorities.

Requirements

• Budgeting, Clinical Trial Management Systems (CTMS), Clinical Trials, Compliance Management.
• Contract Management, Developing Others, Execution Focus, Fact-Based Decision Making.
• Inclusive Leadership, Laboratory Operations, Leadership, Process Improvements.
• Program Management, Project Integration Management, Research and Development, Research Ethics, Resource Planning, Team Management.

Benefits

• Vacation – 120 hours per calendar year.
• Sick time - 40 hours per calendar year; varies 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.
• 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.