Therapeutic area: Rheumatology

Therapeutic areas: Biosimilars and Oncology Supporting scientific and medical affairs in the launch of biosimilar products with initial approvals in oncology.

Therapeutic area: Neurology - Parkinson's diseaseSupporting scientific and medical affairs in the launch of a novel first in class therapeutic approved for the treatment of complications from a Neurodegenerative disease.• Develop relationships with healthcare professionals (external experts, key opinion leaders, thought leaders) in clinical practice, clinical research and basic research in neurology• Serve as a scientific liaison between the medical community and internal stakeholders• Serve as a local resource for medical and scientific education in the healthcare community

SC, works with life science teams to develop and execute strategies that improve operational excellence and performance. SC’s areas of expertise include strategic planning, leadership governance, post-merger integration, process improvement, organizational design, behavioral management, change management and operational improvement. Sample of my projects:• Set up systems and processes for the review, approval, and administration of support for investigator-initiated trials (IITs) for a global pharma organization. Worked with vendor to configure system of online submission and management of IIT applications. Responsible for requirements development, process mapping, and testing to ensure business critical success factors were successfully implemented as well as subsequent trainings to ensure process adherence.• Sponsor/CRO trial liaison and project manager for a non-interventional registry involving 100 sites and 1,000 patients. Collected, integrated and evaluated data from commercial, product training, MSLs, and managing CRO to expedite site activation and study enrollment. Forecasted study enrollment and identified deficiencies. Designed and implemented enrollment support strategies to include: sponsor led all sites calls, monthly newsletters, timed enrollment bonus plan, and MSL enrollment goal contest.• Lead global team in selection of CRO services vendor for global disease registry, post-authorization safety (PASS) and drug utilization (DUS) studies. Accountable for overall project management, qualified vendor identification, RFP development, evaluation criteria and proposal evaluation.• Designed and executed a comprehensive metrics based user engagement strategy comprised of activities tailored to both user type and product life-cycle phase for SC’s SC-Insight business analytics platform. Engagement activities include: user training, creation of user support documents, customer feedback sessions and surveys, and remediation plans for at risk users.

Manage and support all facets of human clinical trials as Clinical Trial Manager. Conduct site identification, recruitment, initiation and training efforts. Assess quotes and contracts, and qualify vendors. Develop, review and implement study protocol, informed consent, CRF, study reports and other study related documents. Forecast enrollment and study supply needs. Monitor project status and timeline. Manage data collection and quality. Working knowledge and adherence to IRB and regulatory policies. Responsible for tracking, summarizing and presenting study updates to company executives.• Conceptualized labeling, packaging and drug distribution scheme that met protocol, sponsor, vendor, site, patient and regulatory requirements for nationwide dose-adjusting clinical trial involving 16 sites, 60 patients, and 8 doses. Directed packaging vendor on implementation. Developed processes, drug management tools, training presentations and SOPs, to train and support site staff, clinical monitors and study staff.• Acted as trial liaison for clinical site personnel, clinical research associates, study management team, medical monitors and trial vendors. Resolved queries and concerns from site staff and investigators promptly through effective communication. • Met with and interviewed KOLs including physicians, pharmacists and facility directors to gain insights into commercial packaging design, government reimbursement and bundling programs, marketing, and comparative analysis of lead compound against market competitors. Communicated customer insights and emerging clinical/scientific trends to internal stakeholders.• Led site identification process. Evaluated site capabilities to deliver forecasted number of patients and high quality data. Made recommendations for inclusion in the clinical trial.• Developed complex study-specific dose adjustment algorithm integrating multiple laboratory parameters that satisfied clinical and study needs while prioritizing safety.

• Advanced pre-clinical program through a change in disease indication through collaboration with a manufacturing vendor to reformulate product for new indication, designed bridging studies and developed a strategy for FDA approval of additional human studies by identifying, analyzing and summarizing supporting data from previous pre-clinical and clinical studies.• Conducted extensive global research review for Australian startup that served as the basis of their “Literature based submission” for drug approval by the Australian Therapeutic Goods Administration. Analyzed data, prepared summary reports and executive summaries to the President and Director, Senior Executives and Regulatory Consultants via multiple software and file sharing applications.

Most Deltanoid employees hold PhDs and have dual appointments with the University. Thus, I still participate in both basic research and research for our pre-clinical programs. Independently designed and conducted original research for multiple projects simultaneously. Trained, supervised and directed graduate candidates, technical staff and students in support of research program. Prepared manuscripts for publication in peer reviewed journals. Two additional publications in development for publication in 2015. Prepared and presented research at several international conferences.