11 - 15 years
Posted 386 days ago
Lead the Clinical and Regulatory Operations Business Unit in the setting of overall direction, strategy and adherence to performance standards. Responsible for the Unit's financial management; meeting budgetary targets for profitability, applying efficiencies for cost effectiveness and overall utilization. Represent company’s Clinical and Regulatory Operations externally to current and prospective clients. Provide leadership to business development activities such as participating in capabilities presentations, bid defence meetings and working withcontracts and proposals service function to develop quality proposals. Oversee the recruitment, supervision and development of staff; ensure available resources balanced withcontracted obligations and corporate objectives.
-Responsible for driving and encouraging a single team approach across all departments to running Clinical trials; delivering with excellence from startup to close out (in accordance with company policies, procedures, SOPs, ICH-GCPs, client contractual expectations and country specific regulatory requirements.
-Provide global direction and oversight for clinical and regulatory operations for full service programs across portfolios and regions.
-Define life cycle management strategies and mobilize required resources to deliver optimal support to project teams through regulatory/start up team, clinical services and client needs.
-Drive the development and integration of required resources, tools, systems, and vendors to support existing and future efficiencies/processes.
-Continually seek opportunities to create and improvement upon regulatory, start up, site id and clinical services in an effort to increase client satisfaction, enhance quality and reduce cycle times.
-Take leadership role with innovation initiatives in support of Company's repositioning as a technology led CRO.
-Support Company's launch of innovative solutions through the implementation of change management programming to ensure adoption and sales for continued growth.
-Define key performance metrics/benchmarks for overall operational management in alignment with CRO expectations and goals.
-Represent the Clinical and Regulatory Operations on the CRO-Leadership Team and other management level teams and committees.
-Serve as client point of escalation and strategic advisor in project oversight, discussion and review, including the management of all project review meetings.
-Assist Sales and Marketing, and Contracts and Proposals in identifying potential clients and projects; collaboratewith these groups to win new opportunities.
-Supports the development of study concepts and protocols in support of Company business development activities.
-Ensure compliance with regulations and industry quality standards and assurance of audit readiness.
-Includes the development of suitable company SOPs and compliance with FDA, EMEA, country specific and ICH-GCP guidelines and representation during audits and inspections.
-Drive process improvement to further streamline efficiencies in operational delivery; including project management methodology and systems within the business unit and across the CRO.
-Set business goals for each level of staff and functional service in support of CRO business targets.
-Create performance management guidelines for managing staff performance, writing reviews and providing difficult feedback.
-Develop and implement business unit on-boarding materials for new employees.
-Facilitate "Engage" training and reinforce concepts throughout employee pool.
-Responsible for ensuring all business unit staff are at the most optimal level for delivering upon contracted agreements.
-Effectively communicate critical updates and changes within company and business unit on a regular basis, acknowledge employee/project successes and address risks to delivery with a focus upon mitigation planning.
-Act as role model to Clinical and Regulatory Operations, providing energy, drive and a proactive, innovative approach to the development of the group.
-Responsible for compensation planning and talent review for overall business unit.
-Proactively participate in the selection and recruitment of suitable and qualified leadership staff.
-Proactively assess, revise and improve training processes and requirements to meet changing needs.
-Support/conduct performance appraisals; coach and develop staff for further advancement or enhanced skill development.
-Provide guidance and mentoring to direct reports (Clinical and Regulatory Leadership Team) and the overall unit staff
-Establish and maintain strong working relationships with clients, vendors and company staff.
-Serve as point of escalation for operational unit; establish and implement client partnerships to ensure long term relationships for repeat and new business.
-Take a lead in the business development of clinical and regulatory services through proposal writing, strategy alignment and coaching staff in bid defense practices
10+ years global drug development, experiencewith deep clinical research and operational strategy experience in the Pharmaceutical/Biotech and CRO industries, Master's or advanced degree in life sciences, pharmacy, nursing, RNpreferred or combination of education of experience.
-Clinical research experience in numerous therapeutic areas, preferably oncology
-Extensive proven project management experiencewithin the Biotech and CRO industries
-Knowledge of ICH-GCP guidelines and industry standards of quality
-Relationship building skills and strong interpersonal presence
-Problem solving capabilities with strong attention to details
-Ability to prioritise multiple tasks and follow to completion with industry expertise
-Strong motivational skills and understanding of customer service