• Advised several startups in the healthcare sector on clinical development and regulatory compliance, leading to a successful launch rate of 80% within their first year of operation, significantly exceeding industry averages.
Professional Overview Continued….
• Developed and refined impactful pitch decks for several startups, contributing to an impressive average of $500K in secured investment per client, significantly accelerating their growth trajectories.
• Mentored entrepreneurs on effective operational efficiency strategies, driving a 30% reduction in resource wastage across multiple ventures while ensuring compliance with regulatory frameworks.

• Directing clinical trial operations for over 3 pharmaceutical and biotechnology companies, achieving a 30% increase in compliance with GCP and FDA regulations across all trials conducted, enhancing overall operational efficiency.
• Managing vendor selection processes and negotiating contracts for projects valued at $50M, resulting in a 20% reduction in operational costs while maintaining high-quality standards throughout the trial lifecycle.
• Developing and implementing comprehensive clinical documents including study protocols and SOPs for several pivotal trials, ensuring alignment with regulatory guidelines that improved audit success rates by 40%.

• Spearheaded the strategic planning and execution of 12 pivotal clinical trials, leading cross-functional teams to achieve an enrollment rate that exceeded projections by 30%, resulting in cost savings of over $2M through effective vendor management and outsourcing strategies.
• Established a comprehensive operational framework for clinical trial programs, ensuring readiness for audits by implementing standard operating procedures (SOPs) that improved compliance metrics by 40% and facilitated successful inspections without critical findings across all trials.
• Drove continuous improvement initiatives within the clinical operations team, mentoring over 15 staff members while establishing key performance indicators (KPIs) that boosted productivity levels by 50%, ultimately enhancing the overall culture of operational excellence throughout the organization.

• Directed a team of 35 operational professionals overseeing clinical trial operations in women's health, oncology, and transplantation, achieving compliance with ICH/GCP guidelines and SOPs while successfully reducing trial timelines by 30% across all programs.
• Spearheaded the Investigator Sponsored Studies Group, effectively managing a portfolio of 20+ studies and optimizing resource allocation through strategic staffing initiatives that improved departmental efficiency by 40% and reduced budget overruns by $500K.
• Developed and implemented robust tracking systems for Phase I-IV clinical trials, resulting in the creation of comprehensive master files that enhanced data integrity and accessibility for over 10 trials, leading to a 25% increase in successful regulatory submissions.

• Spearheaded the management of 10 complex global clinical trials targeting rare neurological diseases, achieving a 95% adherence rate to timelines and delivering crucial data for regulatory submissions ahead of schedule by an average of 3 months.
• Drove initiatives energized operational excellence within clinical programs, leading to a reduction in protocol deviations by 30% and increasing overall patient satisfaction scores to above 90%, thus reinforcing commitment to patient-centered care throughout the trial lifecycle.
• Orchestrated strategic collaborations with cross-functional teams to optimize trial designs and improve logistical efficiencies, ultimately facilitating a decrease in overall trial costs by 20%.

• Spearheaded a leading oncology trial for metastatic solid tumors, successfully enrolling over 400 participants across six different indications, demonstrating a commitment to advancing cancer research and treatment options.
• Orchestrated seamless trial operations by establishing robust communication protocols and standardizing processes across multiple sites and vendors, resulting in a 30% increase in operational efficiency and adherence to clinical research timelines.
• Championed cross-functional team collaboration in data analysis and data collection by implementing strategic project management tools, ensuring all compliance requirements with Nektar SOPs were met consistently while achieving an impressive 95% on-time deliverable rate.

• Spearheaded operational oversight for 8 clinical trials across three therapeutic areas, enhancing compliance with
regulatory standards and resulting in a 20% reduction in protocol deviations while achieving milestones ahead of schedule.
• Orchestrated vendor selection processes that streamlined contract negotiations and budget management, leading to a 30% cost reduction on trial logistics and improving project timelines by 25% through effective stakeholder alignment.
• Directed cross-functional teams composed of over 50 members to execute critical trial deliverables including data reviews and safety assessments, contributing to the successful submission of five regulatory applications within established deadlines.

• Achieved full-time conversion and accelerated promotion to Senior Clinical Trial Manager within seven months by consistently delivering on key clinical operations initiatives and problem-solving, resulting in a 30% increase in
project throughput across the department.
• Managed over 10 complex clinical trials simultaneously, maintaining oversight of budget allocations exceeding $15 million and ensuring successful trial execution through strategic resource optimization that reduced operational costs by 20%.
• Directed high-impact research programs funded by BARDA, successfully aligning regulatory compliance with national health priorities while facilitating monitoring visits and cross-functional collaboration and partnerships that enhanced study timelines by an average of 25%, leading to faster delivery of critical medical solutions.

PHARMACEUTICAL PRODUCT DEVELOPMENT (PPD) – PHILADELPHIA, PA
• Spearheaded the management of three oncology studies across four protocols, collaborating with 62 U.S. sites to ensure 100% compliance with ICH/GCP standards, resulting in zero protocol deviations during audits and enhancing site engagement by 30%.
• Orchestrated comprehensive training programs for CRA teams, investigator meetings, and engineered innovative electronic Protocol Implementation Plans (ePIPs), which improved recruitment strategies by 40%, and regulatory
Page4
Professional Overview Continued….
● compliance, leading to a successful enrollment rate that exceeded targets by an impressive 25% and improved patient follow-up.
• Supervised two global studies, including a multi-national prospective melanoma trial involving over 150 participants; streamlined IRB submissions and drug inventory processes across 21 U.S. sites, achieving an average drug accountability accuracy rate of 98% while maintaining strict adhere

• Facilitated the successful execution of two major clinical studies, including a multi-national trial for unresectable melanoma and a randomized double-blind study, contributing to the advancement of innovative therapies for over 300 patients while maintaining quality assurance.
• Managed clinical monitoring documentation and ensured site oversight across 21 investigational sites nationwide, achieving a 98% compliance rate with study protocols and enhancing data integrity which led to a reduction in
regulatory issues by 40%.
• Cultivated strong partnerships with site personnel through regular training sessions and feedback loops, resulting in improved site data collection and engagement scores by 30% and expediting patient recruitment timelines by an average of three weeks per site.