Associate Director, Portfolio Lead, Clinical Programming

Janssen Research & Development, L.L.C., a division of Johnson & Johnson’s Family of Companies is recruiting for Associate Director, Portfolio Lead, Clinical Programming located in Titusville, NJ.

At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found.

Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Please visit http://www.janssenrnd.com/ for more information.

Within our Integrated Data Analytics & Reporting (IDAR) Clinical & Statistical Programming (C&SP) group we have Associate Director, Portfolio Lead, Clinical Programming opportunities.

We are seeking highly qualified functional area project and people leaders with experience in clinical programming strategy, concepts and processes, industry standards, e.g. CDISC submission ready SDTM packages. Experience with complex data structures, metadata driven data transformation and/or cross and study specific reporting solutions to aid in monitoring of safety, risk and compliance supporting our Risk-Based Central Monitoring team.
This position is responsible for high degree of autonomous decisions and recommendations that impact the efficiency, timeliness and quality of deliverables and provide leadership, direction technical and project specific guidance to programming teams.

Key Responsibilities:

• Accountable for strategy, planning and execution of programming team activities across Therapeutic, Disease Area/Value Stream or Reporting Group.
• Proactively evaluates resource demand and allocation to meet current and future business needs ensuring effective utilization of resources and maintenance of functional planning systems.
• Responsible for anticipation, early detection, prevention and management of risks and issues.
• Accountable for actively seeing opportunities, evaluating and driving solutions to improve efficiency and knowledge-sharing across portfolio, programs, value streams and the department.
• Leads, provides strategic direction and/or sponsorship of initiatives regarding clinical programming capabilities, clinical standards development, implementation, training and programming support across the portfolio.
• Serves as a clinical programming expert and influencer on industry work groups.
• Ensures compliance of assigned teams and personnel with company and department SOP’s, policies and regulatory guidance documents.
• 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

As Portfolio Lead overseeing the Reporting Group:

• Serve as a primary report delivery contact for key stakeholders including Risk Based Central Monitoring, Data Management, clinical study team members, Clinical Scientists and Physicians.
• Partner with functional experts to translate requirements for data and reporting solutions creating standardized, replicable outputs and visualizations templates.
• Conceptualize new strategies that contribute to the improvement of existing reporting solutions.

Qualifications
Education and Experience Requirements:

• A minimum of bachelor’s degree and/or equivalent in computer science, data science/data engineering, mathematics or another relevant scientific field is required. Advanced degree (Master’s, PhD or equivalent) preferred.
• A minimum of 10 years clinical programming experience with growing responsibility, Masters/MBA - at least 8 yrs. proven experience or PhD in a relevant field - at least 5 years proven experience. Experience in a pharmaceutical/ clinical trial environment preferred.
• Oncology or Early Development experience preferred.
• Advanced knowledge of data structures and relevant programming languages for data manipulation and reporting. May include SAS, Python, R, Spotfire, ADAM etc. Knowledge of SAS is required.
• Expert CDISC SDTM knowledge, CDISC submission ready SDTM tabulation packages (aCRF, define.xml, cSDRG, etc. is strongly 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 helpful.
• Excellent communication, influencing skills.
• Demonstrated people leadership skills and experience in staff performance management and people development.
• Demonstrated experience successfully leading broad scope process improvement/innovation initiatives and/or supporting organizational change.
• In depth knowledge of regulatory guidelines (e.g. ICH-GCP) and relevant clinical R&D concepts.

Other:

Locations include: Springhouse, PA, Titusville, NJ, Raritan, NJ, Beerse, Belgium, Leiden Netherlands, High Wycombe, UK or Allschwil, Switzerland, Shanghai China and Beijing, China.

20% Travel

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Primary Location
United States-New Jersey-Titusville- Other Locations
United States-New Jersey-Raritan, United States-Pennsylvania-Spring House, United Kingdom-England-High Wycombe, Switzerland-Allschwil, Belgium, China-Shanghai-Shanghai, China-Beijing-Beijing, Netherlands-South Holland-Leiden
Organization
Janssen Research & Development, LLC (6084)
Job Function
R&D
Requisition ID
9632200804