Senior Director, Global Head of Monitoring
Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human
health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries - and growing - we look for talented people to grow our business, advance our
science and contribute to our unique culture.
The Senior Director, Global head of monitoring, is responsible for creation, driving and implementation of mature, balanced and broad global monitoring strategy that is inclusive of but not limited to risk based monitoring,
optimizing and focusing of CRA resourcing to high value activities, enhance monitoring expertise on early development studies, appropriate framework for oversight of CRO while leveraging affiliate relationships to augment the execution of our portfolio. The candidate must be able to develop and deploy comprehensive quality management plans for a multitude of monitoring/operating models and very adept at partnering with CROs. The candidate must display high degree of organizational savvy, negotiation skills, emotional intelligence and adept at navigating complex
situations/organizational structure. Ability to work in fast-paced, cross-border, multi-cultural environment with several competing priorities will be a key success factor in this position.
Responsibilities include partnering with the global affiliates in overseeing the global CRA team responsible for monitoring of the early phase oncology in-house studies and oversight of the outsourced studies. Supervisory scope
will involve direct management/development responsibility for one or more line managers (Assoc. Manager/Manager/Sr. Manager level), dotted line reporting and may have multiple individual contributors. In addition, they will lead
work process enhancement/implementation and management/development of the functional team(s) in area of responsibility to drive consistency at a global level.
• Lead functional work process optimization, continuous improvement, and change management in partnership with Clinical Operations leadership team colleagues [Study Management, Site Contracting, Central Support Services and
Clinical Trial Associates].
• Partner with key stakeholders at the affiliates (Medical Director, clinical Research manager/Director, Regulatory, HR, Regulatory etc..) to manage key relationships at local/regional level and maintaining focus on the monitoring and affiliate deliverables.
• Keep local leaders at the affiliate level informed of new studies and processes to ensure alignment at local and regional level
• Extensive use of metrics, KPIs, KRIs, use of analytics and other tracking mechanism for managing the department, studies, risk and performance
• Partner with key functions to lead/support inspection readiness, audits, doing root-cause analysis and authoring CAPAs as needed.
• Line management of CRAs & Associate Directors
• Provide leadership, operational expertise and guidance as a point of escalation for clinical monitoring coordination issues.
• Ensure that employees complete assigned project tasks on schedule and meet/exceed the expectations of that project.
• Performance management: Tasks include and are not limited to: raising/setting/communicating performance standards; performing ongoing performance management activities including individual goal setting/periodic
performance assessments/timely performance feedback/coaching/development planning; and tracking and monitoring attendance/timesheets/expense reports.
• Identify and address performance issues and training needs.
For in-house studies:
• Work with affiliate to ensure all the study activities are occurring per GCP/ICH, Celgene SOPs and local requirements
• Provide input into protocols, accountable for the monitoring function developing high quality monitoring plans and protocol-specific monitoring tools
• Address data and quality issues at the site level by partnering with study management and other stakeholders.
Partners with outsourcing management and counterparts at CROs to align on monitoring strategy, standards, training requirements, risk based monitoring strategy, due-diligence and input into the monitoring section of the Scope of work documents at the affiliate level,
• Develop and track FTE resourcing requirements and participate in headcount planning at a global level.
• Lead interviewing, hiring, training, mentoring, and personnel development activities within area of functional responsibility
• Ensure timely and optimal allocation of staff relative for projects across the portfolio to balance workloads across the team members.
• Interact with Study Teams to ensure consistent functional performance and quality of work.
• Strategically assess metrics and ensure implementation of appropriate measures as necessary to support project or program targets / deliverables.
• Promote a positive work environment and professionalism in work behavior, work ethic, mutual respect, innovation and accountability at all levels.
• Champion ‘customer service’ orientation including establishment/maintenance of optimal working relationships between CRAs, CTAs and Study Managers (SMs) and all Study Team members, including vendors as appropriate.
• Lead strategic planning and process development/ implementation for the function(s), tracking timelines to remain on schedule, and developing contingency strategies, if needed.
• Develop CRA and other functional training materials as needed and provide training and on-boarding to new hires.
• Ensure GCP/ICH and Standard Operating Procedures (SOP) compliance and implementation across clinical trials.
• Lead/participate in meetings to plan and implement cross-functional operational activities to increase quality, productivity, and efficiency within Clinical Operations and with CR&MA.
• Work with associated department management in implementing processes to streamline the delivery of study requirements.
• Lead/participate in the development and review of functional/operational procedures and in resolving complex operational problems
• Ensure effective and efficient collaboration between internal customers and external providers (CROs). Liaise with internal (Study Management, Site Contracting, Central Services, etc.) and external (investigational sites
and vendors) partners/stakeholders to assess functional team processes/performance and opportunities for development/enhancement.
• Lead the global monitoring organization to establish high quality and efficient processes and ensure consistency and alignment throughout the team. Maintain clear lines of communication with functional managers to
ensure high quality deliverables are met.
• Manage personal career development by participating in company-sponsored and other training programs as needed to ensure that skills are developed, maintained, and focused accordingly.
• Perform necessary department administrative functions and additional tasks as requested.
• Develop, coach, motivate, and empower direct reports to have a high degree of accountability for performance and the oversight of key study and program deliverables
• Engage and energize employees through communication of goals, priorities, and other business critical information as well as recognizing and celebrating success and achievements
• Facilitate functional talent development and performance management processes to ensure that individuals are held to appropriate, consistent standards and that key leadership development and succession plans are established
Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job
applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.
Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have
authorization to work for Celgene in the U.S.
BA/BS or equivalent degree in life sciences or allied health field
At least 10-15 years of experience in clinical operations roles, including at least 3 years of multi-national experience and in field monitoring. Line management experience required. This position will be based in Summit, New Jersey
• Experience in field monitoring and/or leading a field monitoring organization
• Experience in how clinical research is conducted in affiliates in MNCs and extensive knowledge of monitoring practices in North America and across different regions across the world
• Experience in Risk based monitoring strategyDemonstrated experience in deploying quality management plans for studies that are managed internally and/or outsourced
• Knowledge of complexities and challenges of monitoring early development oncology studies
• Excellent people interaction and communication skills, strong professional diplomacy and positive attitude a must.
• Ability to develop a customer centric focus/model leveraging different touchpoints that a site has with a sponsor while working with CROs.
• Ability to foster a collaborative team environment, motivate others, work in teams in a matrix environment and with various levels both within Celgene and with vendors as appropriate.
• Excellent problem solving ability, able to lay out a strategic vision for the team, detail oriented, excellent organizational skills, ability to multi-task, re-prioritize duties, and work effectively in a fast paced matrix environment.
• Demonstrated competency in leading cross-functional process improvement efforts.
• Demonstrated leadership and management skills, prior supervisory experience with demonstrated success in managing people, and expertise in mentoring and coaching.
• Demonstrated effectiveness as mentor, coach, and leader
• Demonstrated ability to build and maintain a high performance clinical research organization/team
• Demonstrated ability to develop internal talent and hire talented individuals
• Exemplary leadership / influence management skills with ability to foster partnerships in the matrix organization across functional/geographic/cultural/partner boundaries
• Understanding of financial and resourcing principles and utilization of this knowledge to make sound business decisions.
• Leadership of an organization or team in meeting multiple conflicting priorities and making difficult resource allocation decisions (financial and people)
• Experience in leading/directing change management in a dynamic environment
• Financial budgeting and resourcing planning skills.
• Solid knowledge of ICH/GCP, regulatory guidelines/directives and drug development process. Knowledge of medical terminology.
Strong computer skills to include MS Office: Word, Excel and PowerPoint.
• Excellent oral/written/presentation – communication skills.
• Cross-functional and cross-cultural awareness.
• Minimum of –10-12 years experience as CRA, Study Manager or equivalent including line management of designated roles in pharmaceutical or CRO industry.
• Bachelor’s Degree or equivalent.
• Develops and maintains effective working relationships with people across cultures
• Encourages and supports collaboration across teams, functions, and geographies
• Ensures that conflict is handled constructively so that performance is not impacted
• Displays a willingness to challenge the status quo and take risks
• Translates the organization’s vision and strategies into meaningful plans for the function, connecting them
to the mission of each department/team
• Provides direct reports with appropriate levels of autonomy and decision-making authority
• Foster Teamwork: Fosters an environment where people value each other and recognize the importance of each role in the organization.
• Attract and Develop Talent: Ability to recognize, attract, recruit, hire and develop talent. Builds a culture that encourages learning and continuous improvement. Equips people with the tools, knowledge, and opportunities they need to develop themselves.
• Drive Execution: Sets clear expectations, monitors process, holds people accountable, rewards them appropriately and follows-up. Drives improvement in processes, products and services.
• Set clear vision for the global organization and drive global consistency on performance standards and processes.