CALYX - Key Persons
Job Titles:
- Vice President, Scientific E - Tech Enabled Services
Craig Mooney has nearly 30 years experience in the clinical development industry, with a concentrated focus on optimizing IRT to improve clinical trial efficiencies. Craig brings a unique understanding of IRT from both a delivery and user perspective, having served as the Director of IRT at Bristol-Myers Squibb for most of the past decade and having held roles in clinical operations, IMP packaging, and labeling & logistics. He is considered an industry expert and has been a featured speaker at numerous IRT conferences including positions as Conference Chairman.
Job Titles:
- Manager, Regulatory Implementation
Darren has 25 years in the pharmaceutical industry with experience, knowledge and expertise gained within Regulatory Information Management, Regulatory Affairs, Compliance and Quality Assurance. He currently provides regulatory and consulting services for the implementation and operational use of the Calyx Regulatory Information Management (RIM) system, specializing in EU procedures, XEVMPD, IDMP and Combination Products. Customer focused, Darren supports clients to optimise their use of the RIM system and provides "fit for purpose" solutions to the client's constantly evolving requirements.
Job Titles:
- Vice President, Medical and Scientific Services
In his present role as Neurology Therapeutic Lead, Dr. Rohit Sood has contributed as a scientific lead on over 160 imaging clinical trials spanning the entire spectrum, from early to late phase, across multiple therapeutic areas including more than 40 in neurological indications. He has contributed to the science on several Neuro-oncology, Neurodegenerative, Neuropsychiatry and Rare disease clinical trials and has collaborated with our study sponsors to develop criteria for evaluating the eligibility, efficacy, and safety aspects of their studies. As a senior member of several scientific organizations and societies, Dr. Sood is actively engaged in furthering the science in the clinical trial space.
Job Titles:
- Director, Scientific & Medical Services
Farhan applies his extensive training and knowledge in bone loss mechanisms and imaging - both in pre-clinical and clinical settings - to leading and overseeing varied clinical trials involving the musculoskeletal system. He also serves as a subject matter expert in this area, contributing and facilitating protocol reviews as well as imaging-focused discussions with clients as well as consultation and networking with Key Opinion Leaders in the field.
Job Titles:
- Director of Medical Writing
Kim has held roles of increasing responsibility in Medical Writing since joining Calyx in 2019. Currently the director of a global medical writing team, she standardizes processes to enhance the productivity, quality and timeliness of Calyx's medical writing services while actively contributing to documentation requirements describing central review assessments in clinical trials involving imaging-based endpoints. Throughout her career, Kim has been motivated by opportunities to create and add value to the teams she has worked on, drawing on her experience and lessons learned from regulatory feedback to improve the quality and rigor of medical writing deliverables.
Job Titles:
- Associate Director, Project & Program Management
Lee provides extensive knowledge and oversight in clinical trials in the IRT space. She has designed complex and adaptive RTSM system designs to meet a wide range of needs required in therapeutic areas ranging from oncology and neurology to infectious diseases, and many more. With over 12 years' experience in the pharmaceutical industry, she is viewed as a subject matter expert, reviewing and advising on protocol design and new product innovation and implementation. She manages a team of Business Analysts who ensure Calyx IRT systems are built with efficiency, data integrity, and patient safety in mind.
Job Titles:
- Associate Director, Statistics & Product Support Services
Malcolm is responsible for a team of consultants who contribute to the design, review, and technical live study support for all Calyx IRT studies. He holds a PhD in Statistical Inference, obtained in 2001, and has 20 years of pharmaceutical industry experience. His key interest areas are randomization design and medication management in IRT. Malcolm and his team are subject matter experts in these areas for Calyx and their experience is shared in conferences, publications, and, crucially, in client-facing meetings at any point in the life cycle of a Calyx-supported trial.
Since joining the Medical Imaging team in 2003, Nicholas has held extensive, diverse roles and escalating responsibilities within Calyx's Imaging Operations, Project Management, Medical Imaging Leadership, and Medical Writing, teams. He has a wealth of scientific, regulatory, and operational experience related to the use of medical imaging within the clinical trials setting, having supported over 600 trials, and being published several times during his tenure. His scientific and medical writing experience spans all major therapeutic areas.
Job Titles:
- Vice President, Medical Imaging & Head of Oncology
In leading the imaging component of oncology studies for Calyx's global customers, Oliver leverages his experience from supporting over 600 clinical trials - with various indications, complexities, and in all phases of development - which led to the approval of over 20 oncology treatments. He is co-author of the immune-related response criteria (irRC, 2009), first author of irRECIST (2014), and co-author of Comparison of Assessments using RECIST and irRECIST by Manitz J. et al. (2020).
Peter has a wealth of experience in the use of imaging and other biomarkers for documenting the safety, efficacy, and effectiveness of new drugs in clinical trials. He leads Calyx's Global Scientific and Medical Services team of over 75 scientists and is actively engaged in developing and implementing effective imaging strategies for global clinical development programs. He has authored numerous papers and is regularly involved in research presented at scientific meetings.
As a Medical Writer at Calyx, Sally Han develops Independent Review Charters (IRCs), clinical data forms, results reports, and other protocol-specific documents in support of independent review. Leveraging her training in pharmacy and English‑Chinese interpreting, she has provided support on Chinese and global clinical trials. Prior to joining Calyx, Sally was a Medical Copywriter at a private hospital in Shanghai, where she created and translated physician-related policies, SOPs, medical record templates and other documents.
Job Titles:
- Senior Project Manager & Data Migration Lead
For more than 15 years, Stephan has managed numerous Regulatory Information Management (RIM) projects and complex data migrations. With both technical and business expertise, he has assisted numerous clients with XEVMPD and IDMP implementations, also working with Calyx RIM Product Management as a subject matter expert.
An acknowledged expert in Neuroradiology, Musculoskeletal Radiology, and Interventional Radiology, Stephen brings more than 30 years of broad experience to Calyx. His expertise stems from having served as a board-certified diagnostic radiologist at highly acclaimed healthcare centers, as a senior faculty member at leading academic institutions, and as a trusted scientific advisor to numerous global pharmaceutical companies.
Job Titles:
- Statistical Design & Trial Supplies Consultant
Steve is a member of a team of consultants who contribute to the design, review, and technical live study support for all Calyx IRT studies. He holds a BSc in Pharmacy and has 20 years of IRT experience. Steve is one of the subject matter experts in randomization design and medication management in IRT for Calyx. Prior to joining his current team, Steve functioned as an IRT Project Manager, Solutions Designer, and Production Programmer, giving him a complete background in Calyx IRT system functionality.
Job Titles:
- Director, Technical Solutions
Sylvain has acquired extensive experience in IRT through various roles within Calyx over his 10+ years in the company. It allows him to grasp where IRT can make a difference based on the protocol design, and accordingly advise clinical trial teams what solution is the most suitable for each trial. Sylvain is a key member of the Calyx IRT product core team, acting as an advocate for end-users, as well as sharing his vision with the team to push the boundaries of IRT.