The Director, Functional Management GCO, is accountable for successful country execution of all phases of clinical trials within assigned therapeutic area(s) or specific role(s), including resource allocation, adherence to timelines and budget, compliance with relevant Standard Operating Procedures (SOPs), policies, Health Care Compliance (HCC) and local regulatory requirements. Supports Local R&D Head in shaping and managing local organizational structure to ensure its optimal efficiency. This individual is responsible for line management of Functional Managers, and/or other GCO staff, as required. Oversees staff performance, development, training, project assignments, workload distribution and supports issue resolution with direct reports. Ensures alignment of local goals with organizational objectives. Drives innovative solutions and process improvements for the assigned therapeutic area(s), country and GCO/ Global Clinical Development Organization (GCDO) overall.
· Provide line management to direct reports including setting goals and objectives, performance evaluation and talent development.
· Evaluate and forecast resource needs for assigned portfolio and/or other specific area of responsibility, as required and agreed with local GCO management accordingly.
· Support the flexible resourcing model and collaborate with Flex Resource managers to get qualified staff in a timely manner, provide feedback on flex staff performance and support their on-boarding and off-boarding.
· Interview, hire, develop and train staff.
· Ensure understanding of relevant processes and procedural documents supported by documentation of direct reports’ training compliance, as required.
· Support direct reports in issue resolution and communication with involved stakeholders
· Support local implementation of organizational changes and effectively communicate on priority shifts.
· Review and approve expenses in compliance with the company policies.
· Demonstrate leadership behaviors in alignment with J&J Leadership Imperatives
· Foster an environment that encourages sharing of ideas, information and best practices (internal and external to the organization).
· Provide coaching and mentorship as needed.
· Define, execute or support of long term strategy in alignment with GCO, GCDO and Janssen R&D strategies to position the local and global GCO organization for success.
· Oversight of execution and monitoring of clinical trials through all phases (from feasibility to close-out) and ensuring inspection-readiness within assigned therapeutic area(s) and/or other area of responsibility, as required.
· Ensure relevant operational objectives are met in conformance to ICH-GCP, relevant SOPs and other procedural documents.
· Accountable for appropriate and timely issue escalation and reporting (suspicion) of fraud, scientific/ethical misconduct and health care compliance breach. May contribute to CAPA and issue resolution in accordance with required timelines.
· Shape and maintain strong relationships within local GCO department and Local Operating Company (particularly with Medical Affairs).
· Develop country capabilities for an effective study placement within assigned therapeutic area(s) and/or other area of responsibility, as required.
· Oversight of robust feasibility process and site selection to deliver on country commitments within assigned therapeutic area(s) and strategic goals.
· Support regular metrics review and drive necessary follow-up actions.
· Contribute to development, evaluation and implementation of new processes and systems to improve study management.
· Ensure adequate quality oversight within assigned therapeutic area(s) and/or other area of responsibility, as required.
· Foster a culture of continuous improvement and innovation within the local GCO team.
· Model Credo based culture within the local GCO team.
Bachelor's degree or equivalent required, preferably in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy).
Minimum of 10 or more years of clinical research experience acquired in pharmaceutical industry, or CRO.
Knowledge of medical affairs study operations required.
At least 5 years of line management experience (medium to large size team of direct reports) required.
Proven track record of people and project management required.
Strong in hiring, training, developing and evaluation of leaders and people managers required.
Proven ability to foster team productivity and cohesiveness required
Experience in transforming organizations in response to business needs required.
Excellent knowledge of drug development, clinical research operations and regulatory requirements including ICH-GCP, HCC and applicable regulations required.
Ability to synthesize and evaluate data generated from various reports and sources required.
Ability to manage complexity under pressure required.
Strong decision-making and financial management skills required.
Flexibility to work in a rapidly changing environment with the appropriate sense of urgency required.
Effective issue resolution and ability to generate and implement contingency plans for both productivity and quality issues required.
Strong interpersonal and negotiating skills required.
Excellent organizational skills and the ability to collaborate and handle multiple priorities within a matrix environment required.