Lead the Clinical Development activities for the Company, both strategically and operationally.Link with Cystic Fibrosis, COVID-19 and Long COVID Opinion Leaders and clinical sitesDevelop and implement Early- and Late-Stage trials- and regulatory-related documentsRepresent Clinical Development on core Multidisciplinary Team

On a consulting basis, Lead the Clinical Development activities for the Company, both strategically and operationally.Link with Cystic Fibrosis Key Opinion Leaders and CF TDN clinical sitesDevelop and implement study- and regulatory-related documentsRepresent Clinical Development on core Multidisciplinary Team

On-Demand Talent in clinical and strategic drug development.Hands-on and Leadership Expertise in: pre-clinical-to-Phase II transitions, PK and PDInteract with KOL's in various therapeutic areas to ensure logical clinical studies.Design, Set-Up and Implementation of multicenter Phase I-II-III studies.Orphan and Mainstream Indications.

Contributes business expertise to Q&T Research, a leading privately owned Clinical Research SiteSupport Internal Business Development efforts

Mandate:P&L responsibility of the Phase I Unit; define and attain financial objectives. Ensure employee engagement and customer satisfaction. Measure and improve quality and safety metrics in the performance of Phase I/II studies. Contribute to the growth of Early Clinical Development by leading improvements in operations and by supporting business development efforts abroad and locally.Tactics:• Restructured to reduce silos, interfaces and increase employee engagement, including the reconstruction of one of the key teams in the Unit.• Improved the performance metrics of the Unit in several dimensions and contributed to successful regulatory GCP and GMP inspections.• Maintained the global reputation of the Unit for safe conduct of the most complex First-In-Human studies, several of which involving patient populations.• Provided scientific input to numerous customers and internal teams with regards to study design, selection of proper endpoints and safeguards, regulatory strategy as well as creative operational implementation.

Provides expert advice on Pharmacokinetics, Clinical Pharmacology and Regulatory Strategies.Presents the Pharma, Biotech and Contract Research viewpoints as solutions to development challenges.

Mandate: Perform business development through scientific marketing, partnering and network building. Grow the client base and develop marketing material. Act as an internal and external resource with regards to clinical development strategies, pharmacokinetics and clinical pharmacology.• Grew the potential client base by more than a hundred new leads working in about 80 companies worldwide.• Involved in the Company's expansion in Singapore, a network of collaborating Phase I clinical sites enabling a wider reach in terms of ethnic diversity, and a GLP Bioanalytical Laboratory, destined to offer a greater sample analysis capacity.• Elaborated and deployed business development strategies and Client Relationship Management techniques, ensuring orderly and systematic follow-up, business continuity and prioritization of sales efforts.• Designed clinical programs and studies to meet or exceed client’s objectives, securing potential sales along the way for the company.

Mandate: Head the largest division of the company; up to 5 direct reports and >450 staff, on 3 sites, including a central laboratory. Diversify and grow the client base. Improve a deteriorating work climate.• Grew the Pharma/biotech business segment by 280% in less than 2 years, impacting positively the divisional sales and gross margin, along with jumps of capture rate and book-to-bill ratio for this market segment.• Doubled the pool of potential subjects and gained access to patient populations in demand, fulfilling the needs of the target Client base.• Spearheaded the creation and maintenance of a large Type 2 Diabetes Patient population to support complex Phase I-II POC work in this TA, resulting in top enroller performance in specialty multicenter studies.• Sponsored process and planning improvements, increasing productivity per headcount by 22%, changing positively client’s perception of flexibility and reducing the staff turnover by as much as 50% within a year.• Initiated and developed sales tools and a set of Question & Answer (Q&A) about division services and experience, resulting in 50% shorter response time to Client enquiries.• Reoriented the staff training and profiles toward First-In-Human and Proof-of-Concept studies; giving substantial credibility to Company’s claims in the Pharma/biotech segment of Industry.

Mandate: Head the R&D Team of 14 staff, including Project Managers and Scientists. Prepare clinical development plans and progress the Company’s compounds up to Proof-of-Concept, first-in-class modulators and others identified through the C elegans worm platform.• Lead a drug candidate through Lead Optimization, non-GMP kilo size synthesis, completion of IND-enabling package as well as cGMP API and drug product activities in less than a year.• Sponsored the C elegans screening of libraries of compounds which led to the discovery of new properties for two safe Late-Stage candidates shelved by pharmaceutical companies, thus supporting their clinical re-profiling and a potential for shorter term ROI for Investors.• Instituted standardized procedures for critical activities and lead the transition from academic mindset to a more rigorous IND-stage mindset in line with a Clinical-Stage company. • Championed and instituted from scratch a uniform and continuous performance review and goal-setting process, improving the work climate.• Presented successfully to Board of Directors, Scientific Advisory Board and Investors the non-clinical findings, giving these stakeholders visibility of the ongoing programs.

Mandate: Oversee all PK and Clinical Pharmacology activities. Conceive, direct and interpret Phase I studies. Disseminate PK and pharmacology knowledge in the Company. Evaluate potential drug candidates presented through M&A activities.• Assembled, completed, coordinated the writing and summarized a wealth of PK/Clinical Pharmacology data, resulting in fully compliant Visudyne® submissions (drug-device combination) in respect of corporate milestones.• Involved actively in the scientific regulatory support of worldwide approval of Visudyne®, representing the first treatment of wet Age-related Macular Degeneration, a severely debilitating disease and a huge return for Novartis, Zeiss, Coherent, our partners and stakeholders.• Bridged the Non-Asian PK, Clinical Pharmacology and Phase III Efficacy data with Japan-based studies, leading to Visudyne® approval in Japan.• Transitioned successfully, two preclinical concepts into Phase II programs (both drug-device combinations), resulting in tripling the Company’s pipeline of Photodynamic Therapy-based indications, and co-holder of a patent.• Designed and implemented special single- and multicenter-Phase I-IIIb studies in Oncology and Gastroenterology resulting in coherent Phase IV submissions and added value to a to-be-divested asset.• Evaluated, in collaboration with other section specialists, numerous M&A/in-licensing opportunities, allowing acquisitions that lead to new R&D initiatives and a merger.

Mandate: Head the Scientific Affairs Department (project managers, PK, biostatistics, medical writers, regulatory affairs managers), responsible for delivering high-quality Early-Stage studies meeting regulatory and client’s requirements.• Shifted the study mix from generic bioequivalence work to Pharma/biotech studies (up to 50% of volume), resulting in large increase in gross margin, increased number of studies awarded, and 4 consecutive years of 50% growth in sales.• Structured the Department to be scalable and expandable through a Project Management approach; resulting in being able to cope with awarded volume.• Championed the recognition of the Department and its Scientists, resulting in exemplary employee retention and improved work atmosphere.• Teamed with other senior management to solicit external financing for expansion; was granted.• Instilled a high quality mindset in executing clinical studies, which was consecrated through flawless FDA inspections (no 483 issued).

Accomplishments and Responsibilities:- Headed PK, and contributed to biostatistics and data management- Developed and validated SAS® programs for PK and Statistical analyses- Key player in the implementation of the clinical scientific marketing of the company- Collaborated in the reorganization of the company after the merger with LAB- Oversaw the scientific content of research protocols and reports- Managed the implementation of structured pharmacokinetic programming in the department- Participated in the project management activities