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.

The Clinical Programming Director is a highly experienced functional area leader with expert knowledge of Clinical Programming strategy concepts and processes, industry standards and complex data structures and reporting solutions.

This position requires expert project and people leadership skills with the capability to effectively manage Clinical Programming support across a large portfolio across one or more therapeutic areas and/or disease area strongholds, and all phases of development.

This role reports into a people manager position within the Delivery unit and is accountable to the Senior Director of Clinical & Statistical Programming for assigned activities and responsibilities.

Responsibilities:

Delivery Unit or Disease Area Stronghold Leader:

• Accountable for the operational delivery, quality, and compliance of the assigned portfolio across one or more therapeutic areas and/or disease area strongholds, encompassing all phases of development. Provides input and oversight of regulatory submission strategy related to functional deliverables, where applicable.

• Collaborates with departmental leadership to oversee and coordinate sourcing, budget planning, and strategy for the assigned area.

• Contributes to decisions on business and sourcing strategy, processes, and resource allocation across sites.

• Accountable for driving the overall technical capability strategy and process solutions to enhance productivity, quality, performance, and innovation within the functional area.

• Identifies and drives process optimization and innovation within the assigned area, ensuring alignment of processes and procedures across the organization.

• Manages process and policy compliance in accordance with global, local and project requirements. Ensures appropriate documentation and/or corrective and preventative action planning related to process exceptions or deviations.

• Collaborates and partners with cross-functional leadership to address and resolve issues, championing best practices.

• Collaborates with vendors to optimize sourcing strategies and decisions, ensuring appropriate oversight and governance of vendor engagements.

• Develops and maintains policies and standards applicable across the organization, ensuring compliance within the assigned area.

• Regularly meets with direct reports to ensure consistency and appropriate progress towards project goals.

People Leader:

• Accountable for attracting, hiring, and retaining top talent, managing performance, and actively supporting talent development and succession planning. Responsible for making decisions related to the management of assigned personnel and local administration including space allocation, supplies, budget, and travel, etc.

• Ensures training compliance and development of appropriate job skills for assigned personnel and organization. Oversees work allocation for direct reports, providing coaching and guidance as necessary.

• Collaborates with departmental leadership and partner and stakeholder functions to ensure alignment of departmental roles and responsibilities.

As a member of the Clinical & Statistical Clinical Programming Leadership Team shaping departmental strategy and implementation:

• Contributes to the development and implementation of the functional strategy and vision to meet current and future needs, staying updated with industry trends and policies.

• Provides strategic input and direction in the evaluation and reassessment of departmental policies, procedures, best practices and sponsorship of initiatives and projects.

• Owns one or more business processes/procedures, ensuring they are current and efficient.

• Participates in and/or leads global cross-functional and cross-company initiatives, as applicable.

Qualifications

Bachelor's degree (e.g., BS, BA) or higher and/or equivalent professional experience is required, preferably in Computer Sciences, Mathematics, Data Science/Engineering, Public Health, or another relevant scientific field (or equivalent theoretical/technical depth)

Advanced degrees preferred (e.g., Master, PhD).

Experience and Skills Required:

• Approx. 10+ years of experience in Pharmaceutical, CRO or Biotech industry or related field or industry.

• Approximately 10+ years clinical Programming, data management or Statistical & Clinical Programming experience within the pharmaceutical/clinical trial environment with proven experience in leadership roles. Knowledge of R & Python a plus.

• Excellent people leadership skills. People management experience of 5+ years is strongly preferred.

• Extensive understanding of Clinical Programming practices and systems with strong general knowledge of clinical operations.

• Established track record working on cross-functional teams in a matrix environment and partnering with/managing stakeholders and customers.

• Demonstrated experience managing the outsourcing or externalization of clinical Programming activities in the clinical trials setting (e.g. working with CROs, academic institutions).

• Excellent communication, leadership, influencing and decision-making skills, and proven ability to foster team productivity and cohesiveness, acting as a change agent, and adapting to rapidly changing organization and business environments.

• Demonstrated people management skills and experience in staff performance management and people development.

• In-depth knowledge of regulatory guidelines (e.g. ICH-GCP, CDISC-SDTM) and relevant clinical R&D concepts.

• Demonstrated innovative thinking to allow for optimal design and execution of clinical development strategies.

The anticipated base pay range for this position is $160000 to $276000.

Bonus: - The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/performance year. Bonuses are awarded at the Company's discretion on an individual basis.

• Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.

• Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).

• This position is eligible to participate in the Company's long-term incentive program.

• Employees are eligible for the following time off benefits:

o Vacation - up to 120 hours per calendar year

o Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year

o Holiday pay, including Floating Holidays - up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year

• Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits

The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.