Sr Director Cluster Head Growth Countries Global Clinical Operations

Description:

Johnson & Johnson is currently seeking a Senior Director, Cluster Head Growth Countries, Global Clinical Operations based in Beerse, Belgium; Istanbul, Turkey; Tel Aviv, Israel; Athens, Greece.

Hybrid working model (up to 2 days remote work per week).

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. Learn more at https://www.jnj.com/.

For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges.

We know that the success of our business – and our ability to deliver meaningful solutions – depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.

At Johnson & Johnson, we all belong.

Position Summary:

The Cluster Head is accountable for strategic and operational management of clinical research and development activities in the Growth countries cluster (Greece, Israel, Turkey, South Africa and Sub-Saharan Africa). This leads to successful 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 Cluster head shapes and manages local organizational structures to ensure optimal efficiency and demonstrates an effective issue management across countries. This role is responsible for line management of Functional Managers and other Global Clinical Operations (GCO) staff, as required. Ensures alignment of local goals with organizational objectives. Drives innovative solutions and process improvements for the cluster/region or GCO/ Global Development (GD) overall.

Principal Responsibilities:

• Define and implement long term strategy in alignment with Global Development and J&J Innovative Medicines R&D strategies to position the cluster of countries for success.
• Accountable for attracting, planning, execution and monitoring of clinical trials through all phases (from feasibility to close-out) and ensuring inspection-readiness.
• Ensure all operational objectives are met in conformance to ICH-GCP, relevant SOPs and other procedural documents.
• Ensure adequate quality oversight. Accountable for an appropriate and timely issue escalation and reporting (suspicion) of fraud, scientific/ethical misconduct and HHC breach.
• Accountable for functional budget in according to relevant financial processes.
• Shape and maintain strong relationships within GD and Local Operating Company (LOC) (particularly with Medical Affairs).
• Contribute to development and evaluation of new processes and standards to improve clinical trial management as well as lead their rollout.
• Cultivate a culture of continuous improvement and innovation.
• Model Credo based culture within the local GCO team.
• Contribute to shaping environment for clinical trials in the area.
• Provide line management to direct reports including setting goals and objectives, performance evaluation and talent development.
• Evaluate and forecast overall resource needs for the countries.
• Ensure an efficient utilization of flex model at the countries.
• Interview, hire, develop and train staff.
• Lead organizational changes and effectively communicate on priority shifts.
• Strongly demonstrate leadership behaviors as per J&J Leadership Imperatives.
• Foster an environment that encourages sharing of ideas, information and best practices.
• Provide coaching or mentorship as needed.
  
  

This is not an exhaustive, comprehensive listing of job functions. May perform other duties as assigned.

Principal Relationships:

This position reports to VP EMEA GCO. The position supervises a large regional team of more than 200 associates (J&J and flex staff) and has around 10 direct reports at Senior Manager and Director level.

Primary interfaces: Functional Managers, Regional and/or Cluster Heads, other Local R&D Heads in cluster/region and other GCO staff in the country.

Contacts in the organization: R&D/LOC, departments within and outside of GCO/GD, i.e. Delivery Units, Business Growth, Innovation and Advocacy, Regional Therapeutic Area Experts, EBIS, IDAR, BRQC, HCC, External Alliances etc.

Contacts outside of the organization: Functional management of flex providers, Health Authorities, local pharmaceutical industry associations, investigational sites, local vendors and others.

Qualifications:

• Master’s degree (scientific or business orientation) preferred; advanced scientific degree required.
• At least 10 years of experience of clinical research experience acquired in pharmaceutical industry, CRO or investigational site required.
• Excellent knowledge of drug development, clinical research operations and regulatory requirements including ICH-GCP, HCC and applicable regulations.
• Proven track record of delivering complex, global clinical programs.
• Excellent interpersonal and communication skills. Demonstrated skills in effective communication and influence internal and external partners (e.g. investigational sites, ethics committees, health authorities).
• Experience driving performance through external partnerships, specifically in the areas of CROs, FSP and Central Labs.
• Change management/leadership experience in driving complex transformation effort.
• Strong decision-making and financial management skills.
• Flexibility to work in a rapidly changing environment with the appropriate sense of urgency.
• Effective issue resolution and ability to generate and implement contingency plans for both productivity and quality issues when required.
• Fostering a culture of accountability and empowering others.
• Excellent organizational skills and potential to collaborate and handle multiple priorities.
• Ability to develop strong partnerships in a matrix environment.
• Driving a Credo-based culture, including a diverse and inclusive work environment.
• Demonstrated inspirational leadership of remote teams and experience in setting a vision for the future; a drive for delivering and exceeding business results.
  
  

This position will require 15% domestic and international travel as needed.

Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.