Senior Manager Clinical Operations Early Development

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at .

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:

Job Sub Function:

Job Category:

All Job Posting Locations:

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 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. (Note: J&J office relocates to Maidenhead UK in October 2026).

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 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 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.

Are you interested to join our team Then please read further!

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 behaviors 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:

• Bachelors 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 mediumtolarge 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 decisionmaking 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 ICHGCP 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 fastpaced 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.

#LI-Hybrid

Required Skills:

Preferred Skills: