Experience Inc. Jobs

Job Information

J&J Family of Companies Country Head UK, Global Clinical Operations in England, United Kingdom

Country Head UK, Global Clinical Operations - 2406163893W

Description

Country Head UK, Global Clinical Operations

Johnson & Johnson Innovative Medicine has an ambitious vision to integrate digital into the core of how we work amplifying our core capabilities and making a positive difference to the lives of patients, healthcare professionals, our employees and our communities. We have an exciting opportunity for a Country Head located within commutable distance of High Wycombe, UK, to lead our Global Clinical Operations (GCO) team in the UK within our wider Global Development (GD) business.

The Country Head UK GCO is accountable for strategic and operational management of clinical research and development activities in the UK and the successful country execution of all phases of clinical trials, including resource allocation, adherence to timelines and budget, compliance with relevant Standard Operating Procedures (SOPs), policies, Health Care Compliance (HCC) and local regulatory requirements. The Country Head UK GCO shapes and manages local organisational structure to ensure its optimal efficiency and demonstrates an effective issue management within the country and across countries. This role is responsible for line management of Functional Managers and other GCO staff, as required. Ensures alignment of local goals with organisational objectives. Drives innovative solutions and process improvements for the country/region or GCO/ Global Development (GD) overall.

Principal Responsibilities:

  1. Define and implement long term strategy in alignment with GD and Janssen R&D strategies to position the country for success.

  2. Accountable for attracting, planning, execution and monitoring of clinical trials through all phases (from feasibility to close-out) in conformance to ICH-GCP, relevant SOPs, other procedural documents and local regulations, ensuring inspection-readiness in UK.

  3. Primary point of contact for Health Authority agencies for activities related to clinical operations.

  4. Country legal representative for GCO related activities (authorized to sign contracts and agreements).

  5. Accountable for functional budget and affiliate funding in compliance with relevant financial processes

  6. Shape and maintain strong relationships within GD and Local Operating Company (particularly with Medical Affairs). Might participate in Local Operating Company Management Board and Regional Management Teams

  7. Develop country capabilities for effective study placement

  8. Champion a culture of continuous improvement and innovation. Contribute to development and evaluation of new processes and standards to improve clinical trial management as well as lead their rollout in the country

  9. Ensure quality and performance oversight in the country

  10. Model Credo-based culture within the local GCO team

  11. Contribute to shaping environment for clinical trials in UK (e.g. through involvement in pharma industry associations)

  12. Provide line management to direct reports including setting goals and objectives, performance evaluation and talent development

  13. Evaluate and forecast overall resource needs for the country

  14. Ensure an efficient utilisation of flex model at the country

  15. Interview, hire, develop and train staff

  16. Strongly demonstrate leadership behaviors demonstrative of J&J Leadership Imperatives

  17. Champion an environment that encourages sharing of ideas, information and share findings

  18. Provide coaching or mentorship as needed

Key Working Relationships:

The incumbent will report directly to the Cluster Head or Regional Head, maintaining active collaboration with Functional Managers, Regional/Cluster Heads, and fellow Local R&D Heads within the cluster/region. Seamless interaction is also expected with other GCO staff across the country, including R&D and Local Operating Company teams, encompassing Medical Affairs. Additionally, the role involves establishing effective connections with various departments both within and outside of GCO/GD, such as Delivery Units, Regional Therapeutic Area Experts, Information Sciences, Data management, Quality and Compliance, Health Care Compliance, External Alliances, Contracts and Grants, and other relevant stakeholders. Externally, the Country Head UK will be responsible for managing relationships with flex providers, Health Authorities, local pharmaceutical industry associations, investigational sites, local vendors, and other pertinent entities as necessary.

Qualifications

Education and Experience Requirements:

A Bachelor's degree or equivalent, preferably in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy) is required! An Advanced degree in a scientific field and/or Master’s degree is preferred.

Minimum of 10 years of clinical research experience acquired in pharmaceutical industry, CRO or investigational site.

Excellent communication and leadership skills. Proven ability to foster team productivity and cohesiveness. Ability to manage complexity under pressure. Proven track record of people and project management. Strong in hiring, training, developing and evaluating leaders and people managers. Strong decision-making and financial management skills. Flexibility to work in a constantly evolving environment with the appropriate sense of urgency. Experience in transforming organisations in response to business needs.

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. Demonstrates skills in effective communication with various internal and external partners (e.g. investigational sites, ethics committees, health authorities. etc.). Influential in improving the clinical research environment at a country level. Transformative leader who can shape the organizational culture to improve adoption of future state. Operates with limited supervision.

Proficiency in English. Computer literacy. Strong interpersonal and negotiating skills. Excellent organisational skills and ability to collaborate and handle multiple priorities within a matrix environment. Perform activities in a timely and accurate manner.

What type of mark will YOU make?

By joining Johnson & Johnson you will find boundless opportunities to craft your path & amplify your impact inside & outside our walls. And with our dedication to be the world’s healthiest workforce you can strengthen your body as well and your mind. When you work with us you can touch over a billion lives worldwide every day. And when you apply your talent to our collective purpose there’s no end to the lasting impact we can make together. And that changes everything.

What’s in it for YOU?

It’s vital to us that you feel you can bring your whole self to work; at J&J we provide an environment for you to fulfil your career aspirations as well as promoting your physical and mental wellbeing. You will receive a competitive wage and benefits package as well as benefits that can be tailored to what is valuable to you throughout different stages of your life. Examples of this include: online Digital GP, private healthcare, Retail Vouchers, Discounted & Subsidised Gym memberships and you can get to support community projects as part of our global Corporate Social Responsibility programme.

What we’re about:

We are passionate about our work and play vital roles across a range of professional subject areas, and care deeply about our customers and communities. At Johnson & Johnson our culture enables dynamic and impactful careers. We share a kind of DNA where we’re each

  • Committed to caring

  • Responsible to our communities

  • Ready to apply our knowledge and know-how

  • Unique in our background and experiences

  • The drivers of our own success

  • Passionate about doing what’s right

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified individuals will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Primary Location Europe/Middle East/Africa-United Kingdom-England-High Wycombe

Organization Janssen Cilag Ltd. (7360)

Job Function R&D Management

Req ID: 2406163893W

DirectEmployers