The grand vision behind OncoBay’s CRO solutions has become an exciting reality. Our leadership is a widely respected team of industry professionals with more than 100 years of experience to their credit. They are keenly focused on helping biotech firms conduct effective and efficient clinical trials to advance oncology research.
Krystyna has spent over 25 years in leadership roles in small and large CROs with extensive COO-level experience building operational teams and leading global trial execution. Throughout her career, she has focused on creating an environment of opportunity and hope for patients with cancer and other rare diseases. Now leading OncoBay Clinical, Krystyna continues her mission to change the paradigm of clinical trial operations and patient access through technology and innovation.
Charles has spent over 30 years serving in CFO roles, in the United States and internationally, for a wide range of industries. Prior to OncoBay, he served for nine years as the CFO for a full-service, global CRO. Charles has had extensive M & A experience, both buying and selling, and in subsequent integration. In addition, he has a proven track record for building finance teams in both large and small companies, improving cashflow and driving breaking growth.
Dannelle has over 20 years of global clinical development experience in pharmaceuticals, biotechnologies, and global CRO organizations leading clinical research teams with an emphasis on enhancing the performance and efficiency of oncology clinical research. Dannelle’s expertise and experience range from clinical-development planning and regulatory consulting to leading studies from first in human through FDA and EMA approval. For the past 13 years, she has held executive-level positions focused on portfolio leadership, strategic leadership, and customer-relationship development.
Renee brings over 20 years of leadership experience to OncoBay, having worked extensively in clinical operations and project management. Throughout her tenure as a leader partnering with top‑10 pharmaceutical and biotechnology companies, Renee has been widely recognized as a specialist in cultivating business relationships and operational delivery, encouraging and refining business strategies, and in nurturing client-oriented delivery and growth. Her leadership has spanned a broad range of therapeutic areas, with oncologic and cell-based therapy indications being her focus for the past 20 years.
Anne has over 25 years of industry experience in both small and large global CROs. She has created and developed new departments—including proposals, contracts, change order, site contracts, site payments, site identification, and site feasibility—and has improved the infrastructure of study start-up and TMF operations during her career. Recognized for her expertise in building and enhancing clinical technologies for use by start-up and clinical operations teams, Anne has an ardent enthusiasm for developing efficient and quality processes, building high-performing teams, fostering positive client and vendor relationships, and mentoring and coaching staff to meet or exceed their career goals.
Vice President, Marketing and Business Development
As a clinical research veteran, Richard Busby has over 25 years of experience in both Clinical Operations as well as Business Development. With a proven track record of forging strategic relationships with emerging and established Oncology Biotech and Pharma sponsors, Richard draws from his operational foundation, bringing a practical experience and perspective to discussions with prospective clients. He has worked to assemble and offer a variety of creative models to meet his client’s needs – from functional service models, to customized preferred providers of targeted services, to full turn-key CRO solutions. Now leading OncoBay Clinical Business Development, Richard will focus on working collaboratively and creatively across OncoBay and Sponsor teams to develop and deliver custom-curated solutions with an eye on customer satisfaction above all else.
Lisa is a veteran of the pharmaceutical, device, and biotechnology industries with over 25 years of distinguished successes in Regulatory Affairs, Regulatory Compliance, Quality Assurance, and Clinical Operations. Lisa has held senior leadership positions in Quality, Regulatory Affairs, and Clinical Operations and, given her broad experience in all phases of drug and device development—particularly her specialty in immune-mediated diseases and oncology—she has been sought after by small pharmaceutical and biotechnology companies across the globe to assist in their navigation of the constantly evolving regulatory landscape.
Sharon has over 20 years of global clinical-development experience with a concentration in oncology, and possesses an expertise in all developmental phases, from first in human through phase 4 studies. Sharon has worked in academia and industry (CROs, pharmaceutical and biotechnology companies), and as a physician, is an ardent enthusiast for improving public health and the quality of life of patients. She has devoted her medical career to clinical research and patient centricity, ensuring that each study is completed with the utmost consideration for patient safety, as well as meticulous and accurate medical monitoring.
William Kelce, PhD
Executive Director, Nonclinical and Early Development Strategy
William has over 25 years of executive leadership experience in nonclinical development, with proven oncology expertise that includes a specialization in designing nonclinical development strategies for small molecules, biologics, and advanced cell and gene therapies. Well-known throughout the pharmaceutical and biopharmaceutical industries, William's experience includes the review, preparation, and maintenance of numerous successful regulatory documents and submissions, including IND/NDA/BLA regulatory submissions, orphan drug applications, and fast-track and breakthrough-therapy designation requests.
Executive Director, Patient Access and Network Operations
Pam has more than 19 years of experience in the CRO industry, leading international clinical project management teams. Over the last decade, she has been instrumental in growth of new business, development of client partnerships and improvement of processes. Pam has start-to-finish global program level and clinical trial management experience across all study phases. She has consistently managed high quality clinical trials throughout her career and takes pride in mentoring and fostering career growth within project teams.