Senior Manager Clinical Operations - Early Development

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.

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.

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.

We are searching for the best talent for a Senior Manager Clinical Operations for Early Development & Clinical Pharmacology (ED&CP) accountable for strategic and operational management, and successful country execution of Early Development and/or Clinical Pharmacology (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. This is a Hybrid position (3 days per week onsite, 2 days WFH) located within commutable distance of High Wycombe, United Kingdom.

Purpose:

The Senior Manager Clinical Operations, Early Development is accountable for shaping and managing local and regional organizational ED&CP structure to ensure its optimal efficiency and demonstrates 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 including junior Functional Managers. 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. Ensures mentoring/managing of more junior Managers and can assume cross border oversight.

You will be responsible for:

• Providing line management to direct reports, including setting goals and objectives, conducting performance evaluations, and supporting talent development.
• Evaluating and forecasting resource needs for the assigned portfolio and coordinating plans with the Director, Early Development (EMEA/Americas).
• Supporting the flexible resourcing model by collaborating with Flex Resource managers to recruit, onboard, offboard, and assess flex staff performance.
• Interviewing, hiring, training, and developing team members.
• Ensuring understanding of relevant processes and procedural documents, and maintaining documented training compliance for direct reports.
• Supporting direct reports in issue resolution and stakeholder communications with Ethics Committees, Health Authorities, investigational sites, and study teams.
• Supporting local implementation of organizational changes and communicating priority shifts clearly.
• Reviewing and approving expenses in compliance with company policies.
• Demonstrating leadership behaviours aligned with J&J Leadership Imperatives.
• Fostering an environment that encourages sharing of ideas, information, and best practices internally and externally.
• Providing coaching and mentorship, including conducting accompanied site visits as appropriate.
• Defining and delivering long-term strategy aligned with Global Development, ED&CP, and Innovative Medicine strategies to position local and regional ED&CP for success.
• Attracting, planning, executing, and monitoring ED&CP clinical trials (feasibility to close-out) and maintaining inspection readiness for the portfolio.
• Ensuring operational objectives are met in conformance with ICH-GCP, relevant SOPs, and other procedural documents.
• Escalating and reporting suspected fraud, scientific or ethical misconduct, and healthcare compliance breaches, and contributing to CAPA and timely issue resolution.
• Shaping and maintaining strong relationships within ED&CP, the local GCO department, the Country Head/Local Operating Company, and other partners.
• Developing country ED&CP capabilities and collaborating with Project Delivery Leaders and Site Strategic Leaders to optimize study placement across therapeutic areas.
• Leading a robust feasibility process and overseeing site selection to deliver on country commitments and strategic goals.
• Leading regular metrics reviews and driving required follow-up actions.
• Ensuring adequate quality oversight and inspection readiness across therapeutic areas.
• Overseeing the local ED&CP budget and ensuring accurate financial reporting in compliance with financial processes.
• Collaborating with the Country Head and Functional Managers to implement local processes and regulatory requirements applicable to LD and ED&CP teams.
• Leading development, evaluation, and implementation of new processes and systems to improve ED&CP study management.
• Fostering continuous improvement and innovation within the local ED&CP team.
• Modeling a Credo-based culture within the team.
• Mentoring / managing more junior Functional Managers.
• Assuming cross-border oversight as required.

Qualifications / Requirements:

• Bachelor's degree or equivalent; life science (Biology, Chemistry, Biochemistry), Nursing, or Pharmacy preferred.
• Minimum 10 years' clinical research experience in the pharmaceutical industry, a CRO, or an investigational site.
• Early Development trial experience preferred.
• At least 2 years' line management experience leading medium-to-large teams.
• Strong communication and leadership skills with the ability to build team productivity and cohesion.
• Experienced in recruiting, hiring, training, developing, and evaluating staff; solid decision-making and financial management skills.
• Skilled in issue resolution and in developing/implementing contingency plans to protect productivity and quality.
• Thorough knowledge of drug development, clinical research operations, and regulatory requirements, including ICH-GCP and healthcare compliance.
• Ability to synthesize and interpret data from multiple sources and to communicate effectively with stakeholders (investigational sites, ethics committees, health authorities).
• Flexible and adaptable to fast-paced, changing environments across therapeutic areas; able to operate with limited supervision.
• Proficient in English with strong digital literacy, interpersonal, negotiation, organizational, and multitasking skills in a matrix environment; delivers timely, accurate work.
• Able to work hybrid model: 3 days per week onsite and 2 days per week working from home.

Benefits:

We offer a competitive salary and extensive benefits package. The health and well-being of our employees is a priority, we have a flexible working environment as we value work-life balance. We offer career development opportunities for those who want to grow and be part of our organisation. Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will be considered for employment without regard to any other characteristic protected by law. We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Required Skills: Clinical Research Management, Early Drug Development, Line Management Experience

Preferred Skills: Budgeting, Clinical Trial Designs, Clinical Trials, Compliance Management, Consulting, Contract Management, Execution Focus, Fact-Based Decision Making, Give Feedback, Industry Analysis, Laboratory Operations, Organizing, Process Improvements, Project Integration Management, Research and Development, Research Ethics, Technical Credibility