Oncology C&SP Senior Director

Auris Health

Auris Health

Sales & Business Development
Multiple locations · Neuss, Germany · Issy-les-Moulineaux, France · 4123 Allschwil, Switzerland · Switzerland · United States · France · Raritan, NJ, USA · Germany · titusville, fl, usa · Netherlands · Wycombe District, UK · Belgium · Horsham, PA, USA
Posted on Thursday, September 7, 2023
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Integrated Data Analytics and Reporting (IDAR)

Senior Director, Clinical &Statistical Programming

Position Summary:

The Senior Director, Statistical Programming & Analysis (CS&P) is a highly experienced Functional Area Leader with expert knowledge of CS&P strategy, concepts and processes. This position requires expert people leadership skills with the capability to effectively manage clinical & statistical programming support across a large portfolio, typically across one of more Therapeutic Areas or Functional Areas or Region (eg APAC).

This position is accountable for the strategic and operational leadership of CS&P activities across one or more Therapeutic or Functional Areas, with organizational scope typically > 100 FTE or equivalent budget, across geographic regions or a lower scope in combination with significant additional regional and/or portfolio complexity and/or Functional Areas. 

Strategic leadership accountabilities include driving the development of capabilities and shaping the functional long-term strategy to meet industry needs of the future.  Operational accountabilities include optimal execution for their assigned area in accordance with company and departmental processes and procedures. 

This role is responsible for line management of Therapeutic Area Heads, Portfolio Leads, Technical or Sourcing Heads and Leads and is accountable for the recruitment, performance management, talent development and resource management within their assigned area to meet current and future business needs, driving the overall talent management and sourcing strategy for the department.

Principal Responsibilities:

As Senior TA Head

·       Oversees and ensures effective CS&P delivery across assigned Therapeutic Area/Value Stream Portfolio/Regional Portfolio. Where applicable, provides input to and oversight of regulatory submission strategy as it relates to functional deliverables.

·       In collaboration with departmental leadership, oversees and coordinates sourcing and budget planning and strategy for assigned area.

·       In collaboration with IDAR Therapeutic Area Heads and Leads, provides input on portfolio prioritization and manages resource planning and allocation accordingly.

·       Drives and/or contributes to, decisions on departmental business and sourcing strategy, processes and resource allocation.

·       Identifies and drives process optimization and innovation within assigned area and ensures alignment of processes and procedures across partner functions and key stakeholders.

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

·       Collaborates and partners with cross-functional leadership to drive issue escalation/resolution and champions best practices.

·       Collaborates with vendors to optimize sourcing strategies and decisions. Ensures appropriate oversight and governance of vendor engagements.

As a Methodology & Innovation Head

·       Accountable for the technical and organizational leadership of the C&SP Methodology and Innovation group and it’s effectiveness in support of C&SP Therapeutic Area groups, research and innovation in emerging spaces and standard tools development. 

·       Oversees the development, analysis and evaluation of novel and emerging innovative
technical solutions with a focus on automation and efficiency that drive continuous business improvements (e.g. Artificial Intelligence, Machine Learning, Natural Language processing etc.) . 

·       Provides strategic input into the evaluation and reassessment of systems, technologies and related departmental processes. 

·       Connects and partners across technical groups within J&J to leverage institutional knowledge and solutions. Collaborates with external vendors to optimize sourcing decisions and drive innovation. 

·       In collaboration with departmental leadership, oversees and coordinates sourcing and budget planning and strategy for assigned area. 

·       Provides guidance to the team in building predictive models, developing machine learning solutions, designing experiments, and measuring impact by leveraging tools and techniques. 

·       Establishes processes, methodologies and benchmarks for innovation against current industry trends. 

·       Develops and implements technology and innovation frameworks in line with functional technology strategy. 

·       Develops and maintains policies and standards applicable, department-wide, and ensures compliance within assigned area. 

·       Identifies and drives process optimization and innovation within assigned area and
ensures alignment of processes and procedures across partner functions and key stakeholders.

As Strategy, Sourcing and Process Head

·       Act as internal consulting firm to support the C&SP Head and LT in developing future strategies, key communication to senior management and collating and synthetizing industry view and data

·       Responsible for establishing and maintaining the overall SP&A outsourcing strategy and execution. Determines the SP&A functional outsourcing strategy, together with the Head of SP&A and the SP&A leadership team. Oversees that the appropriate outsourcing strategy is applied. Work with cross functional partners to gain efficiencies where applicable.

·       Oversee process maintenance and development activities across SP&A including takeing a leadership role in the development and implementation of process improvements, guidelines and departmental policies, as related to handoffs/working with functions and suppliers.

·       Work cross functionally in the development and reporting of C&SP metrics to provide business intelligence to the C&SP, IDAR and GD LTs.

·       Portfolio/Resource review, forecasting and recruiting by facilitating regular portfolio reviews, identifying additional permanent or consultant headcount as well as opportunities for full outsourcing and managing the recruiting efforts for new contract and permanent staff.

·       Be a point of contact for all Business Operations representing C&SP to IDAR and GD Board, Steering Committees. Define and drive all communications effort in partnership with GD Communications Teams

As an Organization and Functional Area People Leader

·       Strategic leadership accountabilities include driving the development of capabilities and shaping organizational structures across a large and complex functional portfolio and/or the role’s geographical scope. 

·       This position is a leader in continuous development and adjustment of innovative operating models. Able to lead, inspire and influence large team/organization through rapidly changing business challenges.

·       Decision-making has significant/long-term impact on the direction and effectiveness of the functional and/or regional organization due to the large scope and span of area of responsibility.

·       This position has direct interface with senior stakeholders and influencers across JRD including TA and Functional Leaders in GD, Clinical, GRA, GMS, BRQC, IT, Planning and Finance.

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

·       Able to represent department in cross-functional discussions, step-in for Head of function as needed and lead discussions with senior R&D colleagues to strengthen coordination between cross-functional and cross-sector departments.

·       Externally leading and sought-after for insights and functional expertise from across industry.

·       Sponsors/leads initiatives with impact to drive change within and across functions and sectors. 

·       Provides strategic input into the evaluation and reassessment of departmental policies, procedures and best practices

Principal Relationships:

·       This position reports to Global Head of Function.

·       Internal relationships : Regular and direct engagement with Senior Heads and Matrix Leaders from Janssen Therapeutic and Functional Areas including: Clinical (Therapeutic Area Heads), Portfolio Delivery Operations, Integrated Data Analytics and Reporting, Statistics and Decision Sciences, Janssen Clinical Innovations, Data Sciences, Bio Research Quality & Compliance, Project Management Organization, Global Clinical Operations, Medical Affairs Operations, Global Medical Safety, Global Regulatory Affairs and Operations, Human Resources, Talent Acquisition, Finance, IT,Janssen R&D Procurement, External Alliances and Cross-sector counterparts.

External relationships : Vendor Partners, Consultants, Health Authorities, Professional Societies, Industry Peers and Leaders.   


Education and Experience Requirements:

·       Bachelor’s degree or equivalent in computer science, mathematics, data science/analytics, public health or other relevant scientific field (or equivalent theoretical/technical depth) required. Advanced Degree (Master’s, PhD or equivalent preferred).

·       Approximately 15+ years of experience working in Statistical Programming or Biometrics organizations within the pharmaceutical/clinical trial environment with proven experience in a leadership role.

·       Strong people leadership capabilities and proven experience leading teams with the ability to foster team productivity and cohesiveness. People management experience of 5-7+ years is strongly preferred.

·       Extensive understanding of Statistical Programming practices and systems, with good general knowledge of clinical operations.

·       Demonstrated experience developing talent using relevant personnel policies and procedures.

·       Advanced knowledge of sourcing strategies and resource management.

·       In-depth knowledge of project and risk management.

·       Experience working in a cross-functional environment and demonstrated knowledge of industry trends relevant to Statistical Programming.

·       In depth knowledge of regulatory guidelines (e.g. ICH-GCP), inter-departmental processes and relevant clinical R&D concepts.

·       Excellent leadership, stakeholder management and decision-making skills.

·       Excellent oral and written communication skills, including effective negotiation and influencing skills.

·       Demonstrated experience working in a customer focused environment.