J&J Family of Companies Data Management Therapeutic Area Head Early Development/Clinical Pharmacology in Basel, Switzerland
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Director, Therapeutic Area Head Early Development/Clinical Pharmacology
This position ensures common data management (DM) issues/challenges are identified, across programs within the Disease Area/VS, and addressed through operational risk mitigation/appropriate escalation to the DM Therapeutic Area (TA) Head/DM Head/PDO Disease Area Stronghold Leader. This position ensures there is alignment of Disease Area/VS goals with DM organizational objectives. This position ensures that the Data Management Leaders (DML) and Global Data Managers (GDM) have a good understanding of the portfolio and priorities to allow for pro‐active capability building. This position will be responsible to manage conflicts in priority setting and related resourcing in the respective area. This position is also responsible to collaborate with the IDAR Therapeutic Area Leaders (TAL) to provide input on process optimization and innovation within the Disease Area/VS area assigned, ensuring alignment across Data Management. This position supervises Data Management Leaders and may supervise Global Data Managers. This position is accountable for recruiting, resource planning, management and development of all employees within their organization (DMLs and GDMs) to meet current and future business needs. Coaching and mentoring others as needed. This position provides input into the development of departmental policies, procedures, training and standards
Provides input to Data Management strategy and deliverables, process optimization and innovation across compounds and projects within the Disease Area/VS assigned.1. As an ad‐hoc member of the Data Management Leadership team, contribute to decisions on business strategy, processes, outsourcing and resource allocations. Provides strategic input into the evaluation and reassessment of departmental processes 2. DM Point of Contact to discuss new clinical development programs within the Disease Area/VS and related Licensing & Acquisitions. Communicate updates from the Research & Development/sponsor clinical team to DMLs and GDMs.
Ensure DMLs are allocated to programs and are providing critical functional input and thorough evaluation of proposed programs/trials.
Develops DM sourcing strategy with TA/Disease Area partners and confirms sourcing strategy with DM TA Head/DM Head and Head DM Process and Sourcing.
Ensures accurate budget estimates and predictable delivery of DM activities across the Disease Area/VS portfolio within the agreed upon budget.
Identifies process optimization and innovation within assigned Disease Area/VS and ensures processes and procedures are aligned across value streams across Data Management.
Makes recommendations around process/policy deviations to adhere or adjust to local or project requirements.
Establish strong relations with the Bioresearch Quality and Compliance (BRQC) and Global Quality Services organizations to ensure first time right, build pro‐active risk management plans and drive risk mitigations where appropriate. Provides disease specific and clinical development as well as product knowledge in the assigned Disease Area/VS, including integrated solutions and Real World Evidence. Partners with the DM Therapeutic Area Experts (TAE), and ensures adequate training. Proactively seek information on emerging technology in the Disease Area/VS that could impact DM processes and tools.
Provides leadership to the Data Management team by attracting and retaining top talent, developing team members, and ensuring organizational effectiveness, transparency, and communication.1. Charged with making decisions associated with the management of assigned personnel and local administration, including hiring, performance management, space allocation, supplies, budget, travel, etc.
Undertakes people development responsibilities through coaching, training, and performance management as well as ensure compliance with departmental SOP’s, policies and regulatory guidance documents.
Accountable for the decisions made by the Data Management Leaders from a performance perspective.
Coordinates with other Data Management TA Heads, extended leadership team and colleagues to ensure alignment of departmental roles and responsibilitie
Accountable to provide input into the development of departmental policies, procedures, training and standards 1. Policy and standards development and compliance as it relates to the Disease Area/Value stream assigned. 2. Participates in/leads global cross‐functional and cross‐company initiatives, as applicable. Responsibilities for others: Principal Relationships: Functional Contacts within IDAR include but are not limited to: Data Management Head, Functional Leaders, IDAR TALs, IDAR Clinical Data Standards, IDAR Process and Sourcing, Business Operations, Regulatory Medical Writing, Risk Management‐Central Monitoring (as collaborator or peer). Functional Contacts Inside the Company (as collaborator and/or peer) include but are not limited to: DAS Leaders from other departments within Global Development and R&D, eBIS, Quantitative Sciences, BRQC, Project Management Organization, Regulatory Affairs and Operations, Human Resources, Finance, Information Technologies, Janssen R&D Procurement and External Alliances. Cross‐sector counterparts in Consumer and Devices as necessary. Contacts Outside the Company (as collaborator or advisor): Act as J&J representative in Industry counterparts and working groups. Supervision (direct): This position supervises Data Management Leaders and others as assigned.
MS/PhD plus 10-12 years of experience in a leadership function in clinical data management or statistical programming with expert knowledge required in at least one of the two areas.
Excellent people leadership skills and people management experience of 5 to 7 years is strongly preferred.
General understanding of data management and statistical programming practices and systems is needed.
The TA Lead requires a knowledge of regulatory guidance documents such as ICH requirements, inter-departmental processes, and relevant Clinical R&D concepts.
In-depth knowledge of project management, team leadership and people development practices.
This position requires knowledge related to talent development and relevant personnel policies and procedures.
This position requires knowledge of cross-functional working environment and industry
North America-United States-New Jersey-Raritan, North America-United States-New Jersey-Titusville, North America-United States-Pennsylvania-Spring House, Europe/Middle East/Africa-Switzerland-Basel-City-Basel, Europe/Middle East/Africa-Netherlands-South Holland-Leiden, Europe/Middle East/Africa-United Kingdom-England-High Wycombe
Janssen Pharmaceutica N.V. (7555)
J&J Family of Companies
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