About the role
Provide scientific and medical leadership for gastroenterology therapeutic area of responsibility to internal and external stakeholders.The Senior Principal Scientific Affairs Advisor provides strategic scientific, medical, and operational leadership within the Medical Imaging therapeutic area. Serving as a senior subject matter expert (SME), this role partners with Clinical Operations, Medical & Scientific Affairs, Product Development, Data Science, and Business Development to support clinical trial delivery, client engagement, service innovation, and business growth.
The successful candidate will ensure scientific excellence, operational efficiency, and customer satisfaction while driving the development and implementation of innovative imaging solutions across global clinical trials.
Essential Duties and Responsibilities
Scientific Leadership & Strategic Support
Provide scientific, medical, and technical leadership supporting company operations and strategic initiatives.
Collaborate with Business Development to secure new business opportunities and expand market presence.
Serve as a scientific advisor to sponsors regarding imaging strategy and implementation within clinical trials.
Support study teams and internal departments through expert guidance on trial design, image review methodologies, and quality control practices.
Identify and implement innovative tools, technologies, and process improvements to enhance operational effectiveness.
Partner with cross-functional teams to align technology enhancements and service offerings with organizational objectives.
Provide subject matter expertise for software User Acceptance Testing (UAT), client demonstrations, and internal training initiatives.
Support development and review of imaging charters, imaging manuals, review rules, study reports, and other technical documentation.
Ensure scientific accuracy, quality, compliance, and integrity across project deliverables.
Gather and document scientific and business requirements from clients and internal stakeholders.
Contribute scientific expertise to product development initiatives and roadmap planning.
Medical & Scientific Affairs Support
Support the Vice President, Medical & Scientific Affairs in strengthening scientific capabilities and service offerings.
Evaluate emerging imaging technologies, methodologies, interpretation techniques, and industry trends.
Contribute to the development of publications, white papers, presentations, and scientific communications.
Lead interpretation and implementation of new imaging criteria and review methodologies.
Review study protocols, imaging charters, and data queries, providing scientific recommendations and consultation.
Monitor departmental performance metrics and identify opportunities for continuous improvement.
Assist with the design, development, and implementation of new scientific services.
Client Partnership & Study Delivery
Maintain strategic client relationships through governance meetings and scientific consultation.
Provide scientific oversight for:
Trial design
Image acquisition
Image quality control
Image review methodology
Review and contribute to key study documents including:
Clinical Trial Protocols
Imaging Manuals
Imaging Charters
Read Rules
Study Reports
Data Transfer Specifications
Data Queries
Represent Clario at investigator meetings, scientific conferences, and sponsor engagements.
Train project teams on study-specific scientific and medical requirements.
Support Clinical Project Management with client communications, issue resolution, and escalations.
Gather and document study requirements and contribute to Business Requirements Documents (BRDs).
Identify, train, and monitor imaging readers.
Participate in read monitoring activities and reader performance reviews.
Address scientific and technical issues arising throughout study execution.
Operational Excellence
Standardize processes and best practices across the therapeutic area.
Monitor operational performance metrics, including reader agreement and quality trends.
Support leadership in prioritizing critical project deliverables.
Identify opportunities to improve reading processes, workflow efficiency, and service quality.
Collaborate with Product Development to define and implement technology enhancements.
Partner with Finance, Project Management, and Data Science teams to support forecasting and resource planning activities.
Business Development Support
Partner with Business Development to assess opportunities and organizational capabilities.
Serve as a scientific representative during proposal development and client discussions.
Participate in:
Client Meetings
Bid Defense Presentations
Capability Presentations
Conference Calls
Review and contribute to RFPs, RFIs, and related business development materials.
Support creation of scientific content for marketing collateral and website materials.
Scientific & Industry Leadership
Develop and maintain relationships with Key Opinion Leaders (KOLs) and industry experts.
Stay current with relevant scientific literature, imaging advances, and regulatory expectations.
Participate in scientific conferences through presentations, publications, panel discussions, and educational activities.
Monitor advancements in imaging technologies, methodologies, and regulatory requirements.
Identify innovative approaches to improve image quality, review quality, and reading methodologies.
Team Leadership & Development
Lead by example through professional, collaborative, and customer-focused conduct.
Develop and deliver training programs across multiple functions.
Establish performance expectations and operational best practices.
Collaborate with leaders to support coaching, mentoring, and employee development.
Foster a culture of accountability, scientific excellence, and continuous learning.
Additional Responsibilities
Quality & Compliance
Read, understand, and comply with applicable Standard Operating Procedures (SOPs).
Support review and maintenance of therapeutic area SOPs and quality standards.
Participate in continuous improvement initiatives supporting departmental compliance and operational excellence.
Team Contribution
Collaborate with internal stakeholders to resolve operational and technical challenges.
Support employee training and professional development initiatives.
Identify opportunities to improve organizational effectiveness and departmental performance.
Contribute to a positive, collaborative, and high-performing work environment.
Perform additional duties as assigned.
Qualifications
Education
Required
Bachelor's degree in Life Sciences, Medical Imaging, Medicine, Clinical Research, or a related scientific discipline.
Preferred
Master's Degree (M.S.)
Doctor of Philosophy (Ph.D.)
Medical Doctor (M.D.)
Experience
Minimum 10 years of clinical trial experience within a CRO, pharmaceutical, biotechnology, or related research organization.
Extensive experience supporting imaging-based clinical trials.
Experience working within regulated environments, including:
GCP
GLP
ICH Guidelines
FDA Regulations
ISO Standards
21 CFR Part 11
Experience in project planning, reporting, financial management, and resource coordination.
Demonstrated scientific research experience and established publication record.
Experience collaborating with cross-functional stakeholders and external sponsors.
Knowledge, Skills & Abilities
Advanced knowledge of clinical research methodologies and medical imaging applications.
Strong understanding of project management and data management principles.
Excellent written, verbal, presentation, and interpersonal communication skills.
Strong documentation, organizational, and time management skills.
Demonstrated ability to influence stakeholders and provide scientific leadership.
Ability to effectively communicate with clients, sponsors, and cross-functional teams.
Strong analytical, problem-solving, and decision-making capabilities.
Proficiency with Microsoft Office applications, including Word and Excel.
Ability to maintain a professional, positive, and collaborative approach in a dynamic environment.
Strong commitment to quality, customer service, and continuous improvement.
Working at Clario, a Part of Thermo Fisher Scientific
At Clario, part of Thermo Fisher Scientific, you'll have the opportunity to contribute to groundbreaking clinical research that helps bring innovative therapies to patients worldwide. Join a global team dedicated to scientific excellence, collaboration, and making a meaningful impact on human health.
EEO Statement
Clario is an equal opportunity employer. Clario evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status, or any other legally protected characteristic.
Originally posted on Himalayas