Job description
About Calyx
Our mission is to shape the future of clinical research. With decades of experience and the brightest minds in the industry, we help the global biopharmaceutical industry bring new, advanced medical treatments to market, faster.
We seek to change the world, and with the support of our teams across the globe, we flourish together. At Calyx, we are one team. We learn, grow and win together.
Are you ready to help change the world?
Apart from job satisfaction, we can offer you:
HEALTH:
- Medical, Dental and Vision benefits for you and your family, including Flexible Spending Accounts (FSA) and Health Savings Accounts (HSAs)
YOURSELF:
- Paid time off policy including holidays and sick time
- Internal growth and development programs & trainings
WEALTH:
401(k) program, life & accident insurance and disability insurance
401(k) program, life & accident insurance and disability insurance
About the role
About us:
Here at Calyx, our mission is to shape the future of clinical research. Backed by decades of diverse global experience and the brightest minds in the industry, with our industry leading technology solutions, we support the Clinical Research industry bring new, advanced medical treatments to market, faster.
At Calyx, we are one team. We learn, grow and win together. Wherever you are in the world, by working for Calyx you will be supported by a team whose values and goals match your own and who are passionate about helping others.
Are you ready. To help us. Change the World.
At Calyx, we are one team. We learn, grow and win together. Wherever you are in the world, by working for Calyx you will be supported by a team whose values and goals match your own and who are passionate about helping others.
Are you ready. To help us. Change the World.
Job Purpose:
Provide medical/scientific leadership on imaging-related projects. Serve as medical/scientific liaison to clients and subcontractors providing medical services. Provide medical/scientific consulting to clients. Lead project related aspects of charter and application development, medical documentation and independent reviewer quality monitoring from a medical/scientific perspective collaborating with the project team. Assist in marketing and sales of products and services. Provide medical and scientific guidance to new service/product development. Manage medical/technical staff.
Key Accountabilities:
Relationship management
- Supports communications and relationship needs of stakeholder groups.
- Supports communications/stakeholder engagement strategies into specific activities and deliverables.
- Contributes to open communication and discussion between stakeholders, acting as a single point of contact by developing, maintaining and working to stakeholder engagement strategies and plans.
- Provides informed feedback to assess and promote understanding.
- Facilitates business decision-making processes.
- Captures and disseminates technical and business information.
Quality assurance
- Contributes to the collection of evidence and the conduct of formal audits or reviews of activities, processes, data, products or services.
- Examines records for evidence that appropriate testing and other quality control activities have taken place and determines compliance with organizational directives, standards and procedures.
- Identifies non-compliances, non-conformances and abnormal occurrences.
- Perform quality control and evaluation of the results of independent review and provide necessary guidance and feedback to independent readers
- Develop, as necessary, and ensure compliance with relevant standard operating procedures
Learning delivery
- Responsibility for the development and delivery of learning activities to a variety of audiences.
- Teaches, instructs, trains students/learners to develop knowledge, techniques and skills using appropriate methods, tools, online environments, equipment and materials.
- Oversees students/learners in performing practical activities and work, advising and assisting where necessary.
- Provides detailed instruction where necessary and responds to questions, seeking advice in exceptional conditions beyond own experience.
- Identifies knowledge and skills gaps of the team, putting plans in place to address and meet and deliver the wider strategic plan
- Contributes to the development of examples and case study material for use within pre-defined learning material.
Performance management
- Manages individuals and groups.
- Allocates responsibilities and/or packages of work.
- Provides support and guidance as required, in line with individual's abilities.
- Delegates responsibilities as appropriate.
- Advises individuals on career paths and encourages pro-active development of skills and capabilities.
- Sets performance targets, and monitors progress against agreed quality and performance criteria.
- Provides effective feedback, throughout the performance management cycle, to ensure optimum performance.
- Mentors individuals, possibly within other parts of the organization.
- Participates, as appropriate, in formal processes such as compensation negotiations and disciplinary procedures.
- Ensure all people related KPI’s and activities are consistently and fully achieved.
Resourcing
- Implements resource plans, including conducting recruitment interviews.
- Facilitates selection, assessment and on-boarding processes, and internal resource allocation.
- Responsible for regularly reviewing knowledge, skill and competence across the team and taking proactive steps to ensure strategic delivery and mitigate current and future risk
- Contributes to transitioning of resources, complying with relevant statutory or external regulations and codes of good practice.
Sales support
- Provide medical/scientific, and technical leadership for specific therapeutic area(s)
- Work with key opinion leaders and criteria authors to refine assessment criteria
- Support Marketing in the preparation and participation of webinars, symposiums, industry conferences, journal articles, white papers, etc.
- Contributes to Assist in the preparation of client proposals
- Develops sales and marketing presentations to potential clients
- Participate in industry meetings and/or presentations to promote awareness of Calyx and it’s solutions
Specialist advice
- Actively maintains knowledge in one or more identifiable specialisms. Provides detailed and specific advice regarding the application of their specialism(s) to the organization’s planning and operations.
- Recognizes and identifies the boundaries of their own specialist knowledge. Collaborates with other specialists, where appropriate, to ensure advice given is appropriate to the needs of the organization.
- Support therapeutic and strategic meetings within the Scientific and Medical Services
- Support therapeutic area strategy work
- Support Engineering to develop core analysis applications to meet business needs
Project / Protocol
- Provide scientific/medical expertise for Reviewer Training including: slide preparation, selection of training/testing cases, preparation of training/testing cases, preparation of clinical dossier (as needed), preparation of training documentation
- Responsible for the development of imaging parameters to ensure standardization of imaging techniques
- Provide medical/scientific guidance for imaging charter development
- Provide medical/scientific guidance for development of electronic case report forms (eCRFs) the customization of image analysis software tools
- Lead training of independent readers (i.e. radiologists, oncologists) on the use of imaging software, eCRFs, and implementation of the review criteria
- Attend investigator meetings to present and train sites and clients on assessment criteria and imaging parameters
- Act as scientific/medical liaison with client project team
- Provide support for the preparation of clinical protocols, journal articles, and other documents for clients/sponsors
Scientific Leadership
- Attend and contribute to study Kick-off and Investigator Meetings
- Review and edit/add comments to the Independent Review Charter
- Attend Charter Discussion Meetings and provide guidance when appropriate
- Review and edit/add comments to key study documents such as Image Acquisition Guidelines, Charter and Analysis requirements
- Conduct Site and/or Reviewer Training, with responsibility for all documentation and slides to be used in advance
- Provide support for Medical Quality Monitoring of Independent Review data
Consultancy
- Takes responsibility for understanding client requirements, collecting data, delivering analysis and problem resolution.
- Identifies, evaluates and recommends options, implementing if required.
- Collaborates with, and facilitates stakeholder groups, as part of formal or informal consultancy agreements.
- Seeks to fully address client needs, enhancing the capabilities and effectiveness of client personnel, by ensuring that proposed solutions are properly understood and appropriately exploited.
- Provide consulting services in area of expertise
Skills:
- Excellent interpersonal, verbal and written communication skills
- A flexible attitude with respect to work assignments and new learning
- Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail
- Ability to work independently with limited mentoring
- Ability to effectively delegate work to team members
- Must have the ability to work methodically in a fast-paced, time-sensitive environment
- Demonstratable ability to apply critical thinking to problems and tasks
- Ability to identify and implement process improvements
- Proactively participates in skills improvement training and encourages their teams to participate
- Ability to identify the appropriate leadership style to manage the individuals in their team
- Maintains an up-to-date awareness of trends, tools, technology, techniques and processes that affect therapeutics and technology within the Life sciences domain
- A self-starter and able to work under own initiative
- Ability to inspire staff to develop to the best of their competencies
- Ability to demonstrate leadership competencies, like global execution, personal ownership, change leadership, strategic thinking, building partnerships, Customer Focused Leadership, talent development, influencing and leading teams, interpersonal awareness
- Proven ability of using Microsoft Office products (including Word, Excel & PowerPoint)
Knowledge and Experience:
- Proven experience managing and leading/mentoring colleagues
- Experience using tools to communicate progress to Stakeholders
- Experience of regulated environments
- Experience with Line Management and conflict resolution
- Experience of working in and knowledge of the life sciences sector
- Solid Professional experience in the same or very similar role
- Proven line management and/or leadership management
- Significant Clinical Trials. Medical Imaging or other relevant experience in pharma, healthcare or academia
- Experience providing consultancy services in own areas of therapeutic expertise, is able to provide advice and guidance to consultants and/or the customer or other stakeholders through involvement in the delivery of consultancy services
Education:
- MD/PhD or MS/MA, BSN, RPh +5 years experience
- BA/BS or Technologist Certification +8 years experience
- English: Fluent
Come as you are.
We're proud to be an Equal Employment Opportunity employer. We do not discriminate based upon race, religion, colour, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.
We're proud to be an Equal Employment Opportunity employer. We do not discriminate based upon race, religion, colour, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.
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