A career is an ongoing journey of discovery: our 50,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.
As the Head, Clinical Applications & Innovation key responsibilities include:
- Provides leadership and direction, on behalf of GCO, for development and implementation of differentiated solutions for the advancement of clinical research. Examples include: engagement with patients and investigative sites; technologies that advance / accelerate the clinical trial processes and solutions that increase the quality and reliability of the data collected in clinical research.
- Pioneers transformative capabilities (processes and technologies) that drive improved performance and accelerate the clinical development timelines.
- Implements patient centric activities in Clinical Operations and Drug development to ensure the company´s industry leading position in this field (e.g. conduct of patient advisory boards)
- Responsible for surveying the external landscape and providing strategic direction on the advancement of external standards, polices and developing technologies that align with EMD Serono’s strategic interests in the advance of clinical research
- As key leader for technologies planning, strategy and implementation, ensures that the company’s clinical trial operational and clinical data architecture is efficient and provides effective interoperability with internal and external organizations (e.g., out partner CROs)
- Ensures business function System Owners are supported and work collaboratively across the organization, in-line with governance and standards
- Works closely with BT leaders to ensure GCO and other cross-functional services meet the needs, driving business objectives for deployment, implementation, validation and roll-out differentiated solutions.
- Develops/implements critical processes that enable patient centricity principles into our protocols and drug development strategies. Where appropriate, ensures the company is in an industry leading position.
- Manage and develop a high performing team ensuring that key deliverables performance measures are achieved.
- Ability to balance the practicalities of the business environment with the potential for exploiting innovation capabilities that might accelerate or increase the probability of success in the implementation of Global Clinical Operations strategies.
- Build clinical innovation capabilities through the deployment of strategies that include but are not limited to: provision of grants and sponsorships; creating, fostering and partnerships with technology or external networks;
- Where appropriate, lead the industry in the development and adoption of processes, standards, infrastructure and technologies that are reliable, flexible and agile and that could influence a significant shift in the company and/or the industry practices
- Understanding of business processes, and anticipate the needs of our future business. Determine both required and significant improvements; and demonstrate the ability to translate ideas into appropriate solutions
- Extensive experience and expertise in clinical applications, clinical development and the application to technological solutions,
- Ability to influence key decision makers in cross-function settings to ensure the priorities of the organization are well understood in the broader context of EMD Serono
- Construct and maintain a culture of open innovation and utilize as a business strategy to advance technology ideas. and products with internal capabilities in order to minimize costs and develop products more efficiently
- Actively monitor industry trends and efficiently evaluate and determine their impact to EMD Serono.
- Ability to present complex ideas/concepts in a simple fashion
- Responsible for the management of indirect departmental budget while ensuring BT spend is appropriately overseen.
- Assist business functions with budget attainment, return on investment calculations, and subsequent management
- Manage spending on an ongoing basis, working within budget
- Manage delivery to financial budgets, timelines and quality
- Ensure the current and future informatics investments are in line with overall GCO and HealthCare strategies. Clinical trial application in industry account for over 50M+ annualized. Ensuring that the financial commitment positions EMD Serono for the future is paramount.
- An R&D organization’s commitment to patient and regulators is data integrity. With the advancement of health informatics, and especially in the clinical operations discipline, the selection of a path forward is critical to our successful completion and acceleration of clinical trials (the rate liming step in clinical development).
- Clinical and operational data about our trials is often used to determine future probabilities of operational success. Ensuring this data is well cared and maintained over long periods of time is critical to the success of an R&D organization.
- Ensure quality, submission and life cycle management supporting clinical study data
- Translates business needs into solutions enabling the organization to be more effective and efficient
- Enable staff across R&D organization to adopt and use applications and technologies
- Support teams across organization with reporting tools and report delivery & interpretation
- Enable information reporting, distribution and availability always cognizant of effectiveness of information and effectiveness of methodology for publication
SCOPE OF PEOPLE RESPONSIBILITY
- Provide functional excellence to own team as well as to colleagues across the organization
- Coach and mentor members of their organization
- Carry out objective setting, performance appraisals and salary reviews, compensation of direct reports and review performance appraisals done by direct reports for other staff within the department and results of the team
- Lead with confidence and inspire; develop individuals within team
- Ability to lead cross-functional, interdisciplinary global teams and achieving work through resources outside of direct control
- Defines team organization, roles and responsibilities, as well as budget.
Who You Are:
- Bachelor’s degree in Life Sciences (e.g., Biology, Chemistry, Pharmaceutical, Mathematics or similar) required; Advanced Degree strongly preferred.
- At least 10 years of experience in drug development in pharmaceutical industry or CROs with advanced degree, 15+ years with Bachelor’s degree.
- Excellent project management skills
- Extensive knowledge of relevant applications and systems used in pharmaceutical industry
- Extensive experience in clinical operations and informatics solution delivery
- Extensive experience preparing and presenting complex idea and data
- Excellent understanding of the drug development and regulatory framework
- Broad knowledge of analytical methodologies
- Demonstrated ability to foster a learning organization.
- Ability to travel domestically and internationally up to 30% of time
What we offer: We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!