Country Head - Global Clinical Operations, India

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 jnj.com.

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Job Function:

Enterprise Management

Job Sub Function:

R&D Management

Job Category:

People Leader

All Job Posting Locations:

Hyderabad, Andhra Pradesh, India, Mumbai, India

Job Description:

Global Clinical Operations (GCO)

Director Country Head*

(*Title may vary based on Region or Country requirements).

Position Summary:

• A Director Country Head is accountable for strategic and operational

• management of clinical research and development activities in mid to large-size country (as determined by GCO Leadership).

• The Director Country Head is accountable for the 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 in the country.

• The Director Country Head shapes and manages local organizational 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 (FM)/Clinical Research Managers (CRM) and other GCO staff, as required. Ensures alignment of local goals with organizational objectives.

• Drives innovative solutions and process improvements for the country/region or

• GCO/Global Development (GD) overall.

Principal Responsibilities:

1. Define and execute long term strategy in alignment with GD and JJIM 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) and ensuring inspection-readiness in the country.

3. Accountable for ensuring all operational objectives are met in conformance to ICH-GCP, relevant SOPs and other procedural documents and local regulations (including safety reporting).

4. Accountable for an appropriate and timely issue escalation and reporting (suspicion) of fraud, scientific/ethical misconduct and health care compliance breach.

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

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

7. Accountable for functional budget and affiliate funding in compliance with relevant financial processes. Input to development and enable implementation of budget improvement initiatives.

8. 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.

9. Develop country capabilities for effective study placement.

10. Accountable for the selection of sites to deliver on country commitments and strategic goals.

11. Accountable for ensuring the country compliance with quality and operational metrics.

12. Lead regular metrics review and necessary follow-up actions.

13.Contribute to development and evaluation of new processes (local, regional and global) and standards to improve clinical trial management as well as lead their rollout in the country. Participate as GCO representative on global improvement initiatives.

14. Foster a culture of continuous improvement and innovation within the local GCO team.

15. Model Credo based culture within the local GCO team.

16. Contribute to shaping the environment for clinical trials in the country. Develop plans and strategy for team engagement with local investigational sites, regulatory bodies and key stakeholders within the country, potentially participating in national pharmaceutical associations. May also represent the company in country-level industry forums, initiatives or external alliances.

17. Responsible for line management and development of GCO staff up to Sr Manager / Associate Director level ensuring development plans are in place and performance goals met.

18.Leads country-level talent acquisition and development strategies. Contributes to broader

functional talent strategy.

18.Evaluate and forecast overall resource needs for the country.

19.Effectively manage country budget including the review and approval of expenses in

compliance with company policies and

20.Responsible for the deployment of the One Delivery Model in the country.

21.Accountable for the acquisition of new talents and development of human resources.

22. Lead organizational changes and effectively communicate on priority shifts as required in country and regionally.

23.Strongly demonstrate leadership behaviors in alignment with J&J Leadership Imperatives.

24.Foster an environment that encourages sharing of ideas, information and best practices (internal and external to the organization).

25. Provide coaching or mentorship as needed.

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

Principal Relationships:

• Primary Reporting Structure: Reports to Cluster Head or Regional Head.

• Primary interfaces: FM/CRM, Regional and/or Cluster Head, other Country Heads in cluster/region and other GCO staff in the country.

• Other Internal Interfaces: R&D/Local Operating Company staff (including Medical Affairs), departments within and outside of GCO/GD, i.e. Central Trial Management, Delivery Units (DU), Integration and Process Optimization, Integrated Data Analytics & Reporting (IDAR), BRQC, HCC, External Alliances, Contracts & Centralized Services (CCS) others as required.

• External Interfaces: Functional management of relevant vendors, Health Authorities, local pharma industry associations, investigational sites, and others as required.

Education and Experience Requirements:

• Bachelor's degree or equivalent required, preferably in Life Sciences (e.g., Biology,

• Chemistry, Biochemistry, Nursing, Pharmacy). Advanced degree in a scientific discipline 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 evaluation of leaders and people managers. Strong decision-making and financial management skills.

• Flexibility to work in a rapidly changing environment with the appropriate sense of urgency.

• Experience in transforming organizations 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 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.).

• Influential in improving the clinical research environment at a country level. Visionary leader who can shape the organizational culture to improve adoption of future state.

• ▪ Proficiency in English. Computer literacy. Strong interpersonal and negotiating skills.

• Excellent organizational skills and ability to collaborate and handle multiple priorities within a matrix environment. Perform activities in a timely and accurate manner.

 

 

Required Skills:

 

 

Preferred Skills:

Business Planning, Competitive Landscape Analysis, Corporate Management, Customer Intelligence, Design Mindset, Developing Others, Inclusive Leadership, Industry Analysis, Interdisciplinary Work, Knowledge Networks, Leadership, Operational Excellence, Product Development, Product Development Lifecycle, Program Management, Qualitative Research, Relationship Building, Research and Development