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Description

This role is classified as a Hybrid role meaning it works from the Ridgefield, Connecticut campus, 2-3 days per week.

Provides strategic direction, leadership, oversight and management of the Clinical Systems group. Key leader and decision-maker for creating, maintaining and setting future strategic direction for the highly complex and critical systems infrastructure underpinning all activities across US ClinOps. Leads and oversees all department activities including: entering and handling of data to group-specific systems and conducting system audits. Oversees development and delivery of training programs and technical support for all users of ClinOps systems.

As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies´ success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim´s high regard for our employees.

Duties & Responsibilities

• Provides leadership and strategic direction to the Clinical Systems group.

• Accountable for architecting systems infrastructure underpinning all US ClinOps activities: entering and handling of relevant data to group-specific systems; KPI reporting; managing aggregate spend/Sunshine Act reporting; vetting of investigators and entering and managing of IDBs (Investigative Database); overseeing required system audits and leading the provision of training and technical support.

• Leverages deep technical expertise, knowledge of technology trends, and clinical trials experience to define vision for future evolution of ClinOps systems.

• Guides development and implementation Clinical Systems-specific and trial metrics and tools to report on, provide visibility into, and analyze performance and deliverables.

• Oversee third-party vendor(s) to address performance issue for in-sourced resources (Clinical System Programmers) and ensure deliverables are of high quality within planned timelines against contracted scope of work (SoW).

• Maintains a focused continuous improvement culture by identifying and executing strategies and priorities to enable the Clinical Systems group to deliver value and enhance overall operational effectiveness.

• Actively remains current with industry standards, trends and competitive intelligence on Clinical Systems best practices.

• Leads and fosters a culture of close partnerships with all teams in the US Clinical Operations organization, especially Study Management and Conduct, Site Monitoring, and the ClinOps Analytics group. Additionally, Quality Management, Clinical Trial Supply Unit (CTSU) and Global Sourcing Departments, Global Systems and the CD&O Digital Transformation team to assure a closely coordinated program of activities based on common objectives focusing on value, quality and operational efficiencies.

• Partners with BDS Enabling Functions and local IT organization to ensure the needs of the Clinical Operations function are incorporated into the development of new systems and refinement of existing systems.

• Support Director in management of annual budget and quarterly forecasting for cost center. Monitor expenditure of budgeted funds, when possible build in cost efficiencies and provide justification of variances. Monitor and approve service provider and independent contractor invoices.

• Lead and/or represent Clinical Systems processes on local/global working groups.

• Ensures commitment to customer-centric behaviors: provides visibility to trial teams and broader Clinical Operations into ongoing work through up-to-date tracking; maintains high degree of responsiveness to both internal and external requests; resolve issues by working collaboratively across Clinical Operations and other groups within BI.

• Identifies, develops and/or delivers appropriate training for the Clinical Systems group in partnership with the CO Training team.

• Create a performance-based team culture with clear accountability and a sense of urgency for achieving results. Lead (recruit, hire, coach, develop, motivate, manage and monitor performance) managers and/or professionals in department specific knowledge, process and procedures. Set job expectations, provide regular feedback, conduct timely MAG Plan reviews, identify performance challenges, hold employees accountable to high standards and oversee the creation and monitor the effectiveness of action plans.

Requirements

• Bachelor degree, Science or IT/IS preferred, from an accredited institution.

• Minimum seven (7) years of experience in regulated pharmaceutical or healthcare industry.

• Minimum four (4) years of experience IT experience specific to clinical drug development applications and systems.

• Minimum four (4) years of experience in leading and managing a team relative to staffing, performance management, employee development and engagement and/or leading and delivering complex projects comprised of cross-functional teams.

• Experience initiating and lead department and cross-functional strategic initiatives.

• Demonstrated analytical skills and critical thinking to resolve issues in a variety of complex situations requiring new solutions.

• Demonstrated experience in the regulated pharmaceutical or healthcare industry.

• Thorough understanding of all phases of drug development (I-IV).

• Understanding of federal regulations pertaining to IND and NDA regulations.

• Track record in setting priorities, organization and problem solving skills which support and enable sound decision making.

• Excellent written and verbal communication skills and the ability to be clear and concise in a variety of communication settings.

• Excellent customer service skills and high attention to detail.

• Ability to lead with vision and to develop a high performing team.

• Ability to use and learn system applications, e.g., MS Office, document management systems, etc.

• Ability to travel domestically as needed.

• Agility

• Faster decision-making: Focus more on decision logic, less on consensus of all parties. Limit alignment to the needed degree. Keep external focus at the center.

• Flexibility: Be open for changes. Anticipate and adapt quickly to rapidly developing trends and market conditions.

• Down- (vs. upward) delegation: Actively take decisions in your area of accountability. Involve your leader in case of issues or when it is needed due to, e.g., risk; empower those on your team rather than micro-manage.

• Accountability

• Ownership: Be responsible for the key topics in your area (incl. cross-functional) and make sure that they develop as expected (I treat the Company as my own and take responsibility for results).

• Outcome-based thinking: Focus on the desired outcomes and work backward toward the means to achieve them (rather than process orientation).

• Clear and concise approach: Identify and choose logical alternatives based on a systematic analysis and classification of options.

• Intrapreneurship

• Results-orientation: Take responsibility for solving problems and focus on effective solutions (consider novel approaches) and their fast realization (80:20 rule).

• Smart risk-taking: Stretch outside the comfort zone by taking controlled, acceptable risks. Take the lead in achieving challenging goals. Encourage/empower those on your team.

• Innovativeness: Lead the industry in better ways of serving the customers and drive new, more effective ways of working.

Compensation Data

This position offers a base salary typically between $183,000 and $280,000.  The position may be eligible for a role specific variable or performance-based bonus and or other compensation elements.  For an overview of our benefits please click here. (https://www.boehringer-ingelheim.com/us/careers/benefits-rewards)

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All qualified applicants will receive consideration for employment without regard to a person’s actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.