Assoc Dir PL Clinical Programming

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease and the development of best-in-industry data science capabilities is critical to our ambition to be most innovative healthcare company.

Within our Integrated Data Analytics & Reporting (IDAR) Clinical and Statistical Programming (C&SP) group we are looking for individuals with the motivation to contribute to the growth of our Clinical Programming team. This is an exciting opportunity to be part of a new innovative clinical programming groupthat is pivotal in defining our end-to-end automated data flow supporting next generation data strategies.

The Associate Director, Portfolio Lead is a highly experienced functional area project and people leader with expert knowledge of clinical programming strategy, concepts and processes, industry standard and complex data structures and/or reporting solutions. Excellent people leadership skills and capabilities in overseeing clinical programming and technical activities, and/or teams in accordance with departmental processes and procedures.

The Portfolio Lead is responsible for planning, execution and delivery strategy of all clinical programming activities across the Therapeutic, Disease Area/ Value stream on time within budget, with high quality, consistent with departmental and company quality and compliance standards for assigned area. Provides mentorship and guidance to Clinical Programmer Leads and team members.

This position has overall responsibility for the clinical programming deliverables and is the single point of contact within their Therapeutic, Disease Area/Value Stream in collaboration with other functional area members. They interface with local Clinical & Statistical Programming Head, other Clinical Programming Functional Area leads to provide regular status updates, identify and manage risks and issues, and ensures the appropriate use of escalation pathways.

Additionally, they provide leadership and/or expertise in relevant technical areas and on process improvement, maintenance and innovation initiatives working proactively to connect with teams, peers and leadership within and cross functions, sharing and implementing lessons-learned and shaping processes and practices.

As a functional manager, they are responsible for the recruitment, onboarding, performance management and development of people and future skills and technical knowledge expertise within their reporting line.

Responsibilities Include;

• Accountable for planning and execution of clinical programming activities across Therapeutic, Disease Area/Value Stream on time within budget, and with high quality, consistent with departmental and company quality and compliance standards for assigned area of responsibility.
• Oversees and supervises work allocation of internal and external team members.
• Assesses resource demand and allocation across and within projects and adjusts as appropriate. Serves as escalation point of troubleshooting.
• Responsible for anticipation, early detection, prevention and management of risks and issues impacting clinical programming deliverables. Effectively manages program level issue resolution activities, adopting appropriate escalation pathways as needed.
• Accountable for actively identifying opportunities, evaluating and driving solutions to enhance efficiency and knowledge-sharing across programs, value streams and the department.
• Leads departmental innovation and process improvement projects and, as required, may contribute clinical programming expertise to and/or lead cross functional projects/initiatives.
• Serves as a clinical programming expert and influencer on internal and external (industry) work groups.
• Ensures compliance of assigned teams and personnel with company and department SOP’s, policies and regulatory guidance documents.
• Provides leadership by attracting and retaining top talent, managing performance, actively supporting development, and ensuring organizational effectiveness, transparency, and communication. Provides mentorship and coaching to new programming team members.
• Responsible for local administration and decision making associated with the management of assigned personnel.

• Bachelor’s degree or higher and/or equivalent in computer science, data science/data engineering, mathematics or another relevant scientific field (or equivalent theoretical/technical depth). Advanced degree (Master’s, PhD or equivalent) preferred
• Approximately 10+ years clinical programming experience with increasing responsibility OR Masters/MBA in a relevant field and 8+ yrs. relevant experience OR PhD in a relevant field and 6+ yrs. relevant experience
• In-depth knowledge of protocol, current clinical drug development processes preferred
• Expert knowledge of data structures and relevant programming languages for data manipulation and reporting. May include SAS, R, Python, etc. Knowledge of SAS required
• Expert knowledge of SDTM including Define.xml, CDASH, metadata preferred
• Experience in resource and standards compliance management preferred
• Knowledge of Data Management principles and tools, Clinical Data Management Systems and other clinical data sources preferred
• Demonstrated project leadership experience managing and overseeing programming activities, or equivalent where therapeutic/disease area and portfolio knowledge is required
• Demonstrated experience managing the outsourcing or externalization of clinical programming activities in the clinical trials setting (e.g. working with CROs, academic institutions) is preferred
• Demonstrated people management skills and experience in staff performance management and people development
• Demonstrated experience successfully leading broad scope process improvement/innovation initiatives and/or supporting change management
• Excellent communication, influencing and negotiation skills