Position Summary:The Programming Director is a highly experienced functional area leader with expert knowledge ofProgramming strategy concepts and processes, industry standards and complex data structures andreporting solutions.This position requires expert project and people leadership skills with the capability to effectivelymanage programming support across a large portfolio across one or more therapeutic areas and/ordisease area strongholds, and all phases of development.This position is accountable for programming strategy and delivery of the assigned area in accordancewith company and departmental processes and procedures. In collaboration with departmental andcross-functional leadership/key stakeholders, this position also contributes to process optimization andinnovation while ensuring appropriate cross-functional alignment and engagement when necessary. Assuch this position is accountable to drive the overall technical capability strategy and process solutionsdelivering increased productivity, quality, performance and innovation within the programmingfunctional area.As a people and organizational leader, this position is accountable for the recruitment, performancemanagement, talent development, and resource management within their assigned area to meetcurrent and future business needs, contributing to the overall talent management and sourcing strategyfor the department.As a member of the C&SP Leadership Team, this position provides input into overall departmentalstrategy and drives the development and continuous improvement of departmental policies,procedures, training, and standards.Principal 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 ofdevelopment. Provides input and oversight of regulatory submission strategy related to functionaldeliverables, 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 toprocess 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 relatedto 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 asnecessary.

• Collaborates with departmental leadership and partner and stakeholder functions to ensure

alignment of departmental roles and responsibilities.As a member of the Clinical & Statistical Programming Leadership Team shapingdepartmental 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.

Principal Relationships:This role reports into a people manager position within the Delivery unit and is accountable to theSenior Director of Programming for assigned activities and responsibilities.

• Functional contacts within IDAR include but are not limited to: Leaders and leads in Data

Management and Central Monitoring, Programming Leads, Clinical Data Standards, RegulatoryMedical Writing Leads, and system support organizations.QualificationsEducation and Experience Requirements: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 anotherrelevant 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 programming

experience within the pharmaceutical/clinical trial environment with proven experience inleadership roles.

• Excellent people leadership skills. People management experience of 5+ years is strongly preferred.
• Extensive understanding of 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 rapidlychanging 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) and relevant clinical R&D concepts.
• Demonstrated innovative thinking to allow for optimal design and execution of clinical development

strategies.