Head Clinical Development and Operations - South America Region

The position    

The Local Head Clinical Development and Operations (CD&O) South America is responsible for leading a local CD&O team which is part of the LATAM (in this document referred to as “region”). The responsibilities of the Local Head CD&O South America (in this document referred to as “CD&O country”) is contributing to the performance and excellence of the region.

Within the region the Local Head CD&O country is responsible for executing the CD&O activities on a country level in alignment with the HPBU, Medicine Excellence and CD&O vision, strategies and goals, and operating model to ensure successful delivery (speed &value) of clinical trials in their country and region.

The Local Head CD&O country is responsible for execution and delivery of the clinical trials allocated to the country that meet pipeline commitments, specific scientific medical, regulatory, and commercial needs. Identifies opportunities that create competitive advantage and drives clinical development excellence. Responsible for the performance in their country.

Ensures site & patient engagement strategies are embedded in the clinical trials performed in the country.

Actively interacts with our customers to capture and bring local strategic insights into Boehringer Ingelheim to support our clinical development.

Embraces innovative technologies, as well as creates and maintains a culture that drives empowerment, smart risk taking and one common CD&O identity.

Tasks and responsibilities    

• Ensure the Clinical Development & Operations execution excellence strategy, focusing on delivery of pipeline commitments, effective leadership, and best practice, leveraging data & technology and customer engagement approaches to deliver on competitive timelines and to maximize value for patients.
• Oversight of clinical development portfolio and delivery of pipeline commitments.
• Ensure operational excellence on speed, efficiency and quality of preparation, conduct, analysis and reporting of clinical trials.
• Implement the strategic outsourcing model(s) aligned to corporate strategy.
• Ensure implementation of the site & patient engagement strategies in the clinical trials.
• Actively interacts with customers to identify and capture local insights that improve the customer experience and inform clinical development.
• Responsible for providing local insights including industry benchmarking and feedback from local business and its internal and external stakeholders, as well as to ensure effective and efficient site & patient centric engagement tactics are embedded in clinical trials.
• Expertise on local health care and research environment.
• Increase the awareness of Boehringer Ingelheim’s clinical development program by building up and maintain networks with the internal and external stakeholders, including EEs and patient organizations.
• Foster continuous improvement and innovation by cross functional collaborative approaches that can apply better solutions for clinical trial delivery and execution in the country of responsibility.
• Create an environment that inspires, motivates, and empowers colleagues in the responsible country that promotes one common CD&O identity and is driven by our CD&O behaviors.
• Ensures team members are aware of their accountabilities, responsibilities, and deliverables.
• Ensure implementation of standards, processes, and performance in the responsible country to improve overall clinical program delivery according to plan in terms of efficiency, timelines and quality while containing costs.
• Ensure adherence to national and international regulatory and legal rules, scientific medical and ethical standards, ICH-GCP to safeguard quality, safety and data integrity of clinical trial conduct, compliance with Boehringer Ingelheim internal SOPs and guidelines. Oversee the implementation of global systems, processes, and initiatives in the responsible country.
• Maintain a highly skilled CD&O team workforce of energized employees through hiring talents.
• Responsible for talent identification, development and retention for the team, in alignment with local HR and Head CD&O region.
• Actively participate in talent development discussions for the responsible country within the function and across functions in alignment with the Head CD&O region.
• Identify opportunities for development of team members within the region, globally and cross functionally.
• Representation the voice of the responsible country to contribute organizational effectiveness and best practice sharing, as well as communication of local escalation to Head CD&O region.
• Oversee the responsible country activities to ensure commitments are met, feasibility oversight, trial, and the country performance. Alignment and best practice implementation with the regional CD&O strategy.
• Ensures accurate country budget and capacity management, allocation and forecasting. Facilitates budget / resource allocation to meet objectives and targets the responsible country in alignment with the Head CD&O region.
• Communicate regularly on trial status and clinical operations performance, escalates unresolved or unexpected issues appropriately to the Head CD&O region.
• In alignment with the Local Heads CD&O countries in region build, facilitate and use innovative technologies that support our clinical development on a Region level.

Requirements 

Required: 

• University degree in Health Sciences or related fields. A medical degree will be considered a plus.
• Previous experience in similar positions.
• At least ten years of experience in the pharmaceutical industry.
• Proven record of successful team leadership and management by implementing innovative business /management solutions and change management.
• Solid track record in clinical research.
• Previous experience in roles with regional scope.
• Strong orientation towards management and strategic decision-making.
• Ability to effectively build and manage relationships with different stakeholders internally and externally, engaging with them in a planned and meaningful way in pursuit of the company’s strategic objectives and feeding intelligence back to the company to maximize the deliverables.
• Ability to interpret and apply understanding of key financial indicators to make better business decisions.
• Excellent interpersonal communication skills and teamwork abilities.
• Ability to develop and maintain relations, alliances and coalitions within and outside the organization and to use them to obtain information, support and cooperation.
• Decision taken based on Real World Clinical Outcomes, Health Economic Value, Quality of Care & Efficiency and patient preferences.
• Advanced level of English (spoken and written).