Manager, Clinical Operations, Early Development, Oncology

Johnson & Johnson Innovative Medicine • Spring House, PA

1d • $117,000 - $201,250 • Remote

About The Position

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.

Requirements

• 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 acquired in pharmaceutical industry, CRO or investigational site.
• Demonstrated AI literacy and an AI enabled mindset, including the ability to apply AI tools responsibly in daily work to improve productivity, decision making and quality of outcomes.
• Effective communication and leadership skills. Ability to foster team productivity and cohesiveness.
• Experience in mentoring/coaching others (line management experience desirable). Skilled in leading, hiring, training, developing and evaluating people.
• Solid decision-making and financial management skills.
• Effective issue resolution and ability to generate and implement contingency plans for both productivity and quality issues when required.
• Excellent knowledge of drug development, clinical research operations and regulatory requirements including ICH-GCP, HCC and applicable regulations.
• Ability to synthesize and evaluate data generated from various reports and sources.
• Demonstrated skills in effective communication with various internal and external stakeholders (e.g. investigational sites, ethics committees, health authorities, etc.).
• Flexible mindset and ability to work at a fast paced in a fast-changing environment in different therapeutic areas.
• Operates under limited supervision.
• Proficient in English language.
• Computer literacy.
• Strong interpersonal and negotiating skills.
• Excellent organizational skills and the ability to collaborate and handle multiple priorities within a matrix environment.
• Perform activities in a timely and accurate manner.

Nice To Haves

• ED&CP previous clinical trial experience is preferred.

Responsibilities

• 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, ED&CP, and JJIM R&D strategies to position the local and regional ED&CP organization for success.
• Accountable for attracting, planning, execution, and monitoring of ED&CP clinical trials (from feasibility to close-out) and ensuring inspection-readiness for assigned portfolio and/or other area of responsibility as required.
• Ensure relevant operational objectives are met in conformance to ICH-GCP, relevant SOPs and other procedural documents.
• Accountable for appropriate and timely issue escalation and reporting of (suspicion) of fraud, scientific/ethical misconduct, and health care compliance breach. Contribute to CAPA and issue resolution in accordance with required timelines.
• Shape and maintain strong relationships within ED&CP, local GCO department, local Country head and Local Operating Company and other key internal and external stakeholders.
• Develop country ED&CP capabilities and collaborate with Project Delivery Leaders (PDLs) and Site Strategic Leaders (SSLs) for an effective study placement within the multiple therapeutic area(s) and/or other area of responsibility, as required.
• Accountable for robust feasibility process and oversight of sites selection to deliver on ED&CP country commitments and strategic goals.
• Lead regular metrics review and drive necessary follow-up actions.
• Ensure adequate quality oversight and inspection readiness within the different therapeutic area(s) and/or other area of responsibility, as required.
• Oversight of local ED&CP budget and accurate financial reporting in compliance with financial processes
• Collaborates with local Country Head and Late Development FM to implement specific local processes/regulatory requirements applicable for both LD and ED&CP teams.
• Contribute to development, evaluation and implementation of new processes and systems to improve ED&CP studies management.
• Foster a culture of continuous improvement and innovation within the local ED&CP team.
• Model Credo based culture within the local ED&CP team.

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

What This Job Offers

• Job Type: Full-time
• Career Level: Manager