Business Process Lead

• POSITION
• Business Process Lead
• WHAT - Summary & Purpose Of The Position

The Business Process Lead is a senior individual accountable for the end-to-end management of Clinical Development business processes.

The role will be responsible to ensure that clinical development processes consistently deliver quality, efficiency, and optimize clinical operations outcomes.

• WHAT - Main Responsibilities & Technical Competencies
• The core responsibilities will include
• Strategy & Vision
• Define Clinical Development Process Objectives and Management: Align the process vision, goals, and mission with R&D organisational strategies.
• Set Targets: In conjunction with other CDO/R&D leaders embed the agreed Key Performance Indicators in the CDO framework and processes
• Design and maintain the process Framework: Establish how the processes should be managed within the CDO organization
• Systems

Support: Support evaluation and selection of systems to be used across the Clinical Operations functions.

Ensure integration of systems and processes to drive operational efficiencies across the CDO functions

• Governance & Compliance
• Establish Policies: Develop and maintain the rules, procedures, and controls governing the CDO processes.
• Ensure Adoption: Validate that team members (colleagues and/or FSP) are acting in accordance with the agreed policies and define corrective actions if they aren’t.
• Risk Management: Identify potential roadblocks, conflicts, and risks within the process and put mitigating measures in place.
• Performance Monitoring
• Track KPIs: Continuously monitor and report KPI scorecard to CDO Leadership and Asset Teams on process performance against target plans.
• Evaluate Outcomes: Analyze data gathered from the process to ensure it yields the expected quality and return on investment.
• Continuous Improvement
• Drive Process Optimisation: Champion continuous improvement to eliminate inefficiencies.

Define process changes that mature the Clinical Development processes and improve their overall health.

• Conduct external environment scanning for new ways to optimise the processes across the Clinical Development Paradigm
• Support training material review for new systems and processes
• Stakeholder Alignment
• Cross-Functional Coordination: Synchronize process goals across Clinical Development and cross functional lines that support the asset teams, to prevent disjointed, siloed work.
• Act as the Escalation Point: Serve as the definitive decision-maker and single point of contact when major process-related issues or improvement suggestions arise
• HOW - Behavioural Competencies Required
• Excellence in Execution

Planning and prioritizing work to meet commitments aligned with organizational goals. Consistently achieving results, even under tough circumstances.

• Approaches priority setting and setting the stage through the lens of execution.
• Establishes clarity about the goals, accountabilities, timelines, and next steps; can identify/spot opportunities for real impact on patient and society.
• Able to be focused and performance-driven with clear KPIs.
• Plans and aligns effectively (steps, resources, timelines etc.).
• Displays a commitment to best practice sharing and setting.
• Promotes single point of accountabilities.
• Ensures Accountability

Holding self and others accountable to meet commitments.

• Builds environment where people ask for clarification when accountabilities are unclear.
• Consults/seeks stakeholder views and ensures decisions are made by consent vs consensus.
• Takes personal accountability for decisions, actions, successes and failures. Follows through on commitment and makes sure others do the same.
• Communicates Effectively

Developing and delivering communications that convey a clear understanding of the unique needs of different audiences (CPMs and CRAs)

• Asks open questions and digs deeper; shows care and respect for different perspectives.
• Communicates transparently, tells it how it is while keeping communication respectful.
• Builds clear and crisp messages with structure and focus.
• Taking a stand (courage)

Stepping up to address difficult issues, saying what needs to be said to optimise quality and compliance

• consistently speaks up and challenges the status-quo; takes a stand, is decisive and does what is right, even when it is unpopular;
• Quality driven;
• Faces fears, demonstrates appetite for stepping out of their comfort zone when challenging quality and compliance
• HOW - Knowledge & Experience
• Knowledge & Experience (essential)
• A minimum of 8 years of previous Pharmaceutical Industry experience is required, with at least 5 years of GXP experience within clinical research
• Well-developed skills and knowledge of clinical operations business processes and practices (i. e., SOPs governing clinical research activities)
• A minimum of 4 years experience in development , management and leadership of Clinical Operations Business Process
• Demonstrated ability to deliver a culture of continuous improvement
• Planning and tracking skills, able to see the big picture, well organized, focused on results, customer focused, capable of managing multiple projects, excellent time management with respect to priorities and self-management.
• Knowledge & Experience (preferred)
• Knowledge of the overall drug development process
• Experience across all Clinical Trial Phases 1-4 would be preferred
• Experience in quality assurance activities, including audits of clinical investigative sites, systems and vendors, and audits of regulatory submissions is an asset
• Ability to influence and motivate professional colleagues and stakeholders
• Proven conflict resolution/management and negotiation skills
• Ability to independently plan, organize, coordinate, manage and execute assigned tasks
• Demonstrated clarity of communication
• Demonstrated ability to influence key internal and external stakeholders
• Experience of the key customers’ business processes and practices
• Demonstrated ability to engage with authorities, trade associations and key clinical trial sites

Education / Certifications (essential)

• Bachelors Degree in life sciences or a professional degree in life sciences (eg Nursing , Pharmacy)

Education / Certifications (preferred)

• Project Management Certificate (PMP/PRINCE2 etc.)
• Language(s) (essential)
• Global role so Fluency in English is critical
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