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 the execution and delivery of one or more Therapeutic, Disease Area/Value Stream or Reporting Group, may take additional role responsibilities a business owner for processes or systems or acting as primary point of contact.

This position is responsible for planning, execution and delivery strategy of all clinical programming activities across the Therapeutic, Disease Area/ Value stream or Reporting Group on time within budget, with high quality, consistent with departmental and company quality and compliance standards for assigned area. Accountable for strategic portfolio management including mid and long-term resourcing capabilities and ensuring optimized end-to-end processes and therapeutic and disease area standards are implemented. 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, Reporting Group in collaboration with other functional area members. They interface with Clinical 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.

This position is responsible for high degree of autonomous leadership decisions and recommendations that impact the efficiency, timeliness and quality of deliverables and provide leadership, direction technical and project specific guidance to programming teams.

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.

In Collaboration with senior departmental leadership, this position influences departmental effectiveness acting as a change agent to shape, drive and implement the organizations strategic vision.

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. This position may also take on responsibilities of second line management (i.e. manager of managers).

Principal Responsibilities:

• Accountable for strategy, planning and execution of clinical programming activities across Therapeutic, Disease Area/Value Stream or Reporting Group on time within budget, and with high quality, consistent with departmental and company quality and compliance standards for assigned area of responsibility.
• Proactively evaluates and manages resource demand and allocation to meet current and future business needs ensuring effective utilization of resources and maintenance of functional planning systems.
• Oversees and supervises work allocation of internal and external team members.
• Oversees the design, development, validation, management and maintenance of clinical databases according to established standards.
• 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.
• Can Serve as a business owner for processes/systems of medium/high complexity and/or significant departmental or cross‐functional impact. The individual is responsible for seeking input and making strategic decisions regarding the development, execution, and maintenance of the process/system in collaboration with the others.
• Can act as a primary point of contact for sourcing providers being responsible for establishing a strategic partnership, ensuring adherence to contract agreements, following up on capacity management, deliverables and compliance in close collaboration with other partners and procurement.
• Provides strategic direction and/or sponsorship of initiatives regarding standards development, implementation, training and programming support across the portfolio.
• 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.

As functional area people leader:

• 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.

Principal Relationships:

• Reports into Clinical Programming Head and is accountable for Therapeutic, Disease Area/Value Stream and/or Technical Capability Area programming activities and responsibilities.
• Functional contacts within organization include but are not limited, Clinical Programming Head, Clinical Programming & Statistical Programming & Analysis Head, IDAR Therapeutic Area Lead, Data Management Leads, Clinical Data Standards Leads, Process, Sourcing & Compliance Leads, Statistical Programming Leads, Risk Management Central Monitoring Leads.
• Functional contacts within Janssen (as collaborator or peer) include but are not limited to Global Program Leads, Global Trial Leads, Quantitative Sciences, Biostatisticians, Regulatory, Clinical, BRQC-QP&S, EBIS, Human Resources.
• External contacts include but are not limited to, external partners, CRO management and vendor liaisons, industry counterparts and working groups.

Qualifications

• 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. Experience in a pharmaceutical/ clinical trial environment preferred.
• Expert knowledge of data structures and relevant programming languages for data manipulation and reporting. May include SAS, R, Python, etc. Knowledge of SAS is required.
• Expert CDISC SDTM knowledge.
• Demonstrated project leadership experience managing and overseeing programming activities, or equivalent where therapeutic/disease area and portfolio knowledge is required.
• Demonstrated project leadership managing risks, resources and leading teams to successful outcomes.
• 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.
• Excellent communication, influencing and negotiation skills.
• 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.
• In depth knowledge of regulatory guidelines (e.g. ICH-GCP) and relevant clinical R&D concepts.