Donald Cilla Email & Phone Number

Halifax, Nova Scotia, Ca

Halifax, Nova Scotia, Ca

Leading the development of drug products and vaccines to advance the fight against infectious disease, globally. Aligning portfolio development activities with company goals, prioritizing, and driving programs through development, regulatory approvals and commercialization.

Boston, Ma, Us

Instructor for BIOT5201 – Foundations in Biotechnology course for graduate students admitted to the Master of Biotechnology Program. Instructor for BIOT5227- Economics and Marketing for Biotech Managers. Activities include designing course curriculum, teaching, evaluating, advising and inspiring graduate students in the Masters in Biotechnology program.

Bala Cynwyd, Pennsylvania, Us

Provided program management support, planning, team management, strategy and communications for an investigational gene therapy program

Boston, Massachusetts, Us

Developed and rolled out an operating model, which included a governance model, team structure and responsibilities, sub-team structure and responsibilities. Responsibilities included developing process, structure, tools and templates, analytics, training, and support for the new model.

Boston, Ma, Us

Developed and rolled out an operating model to assist in developing approaches and to maximizing crop yield. Further supported program management by supervising and overseeing staff supporting product development.

Responsible and accountable for responsible for hiring and supervising a team of Program Managers and Program Coordinators that direct the operational, planning, and decision-making processes of multiple programs within Shire’s Early / Global Development Teams, ensures high quality, coordinated support for the programs under their purview, including:• Ensuring a coordinated evaluation of product opportunities/ scenarios and development of comprehensive integrated recommendations (eg, to Governance Committees) and strategic and operational product plans based on program defined objectives.• Coordinating and driving development process planning activities of the E/GDT including Integrated Development Plans, Long Range Plan, budget inputs and go/no go criteria as appropriate.• Facilitating the elaboration, approval and execution of the global program strategy, as well as facilitate decision-making process for their program(s)

Lead2Launch is a pharmaceutical services consulting company, focused on providing drug development, clinical research, clinical pharmacology, clinical operations, and outsource management consulting services.• Product positioning, Disease Area Strategy, Target Product Profiles, Decision-Analysis, Product Development Plan creation,• Clinical trial data analysis, clinical pharmacology plans, outsourcing process, and development team structure, function and implementation/training

Gaithersburg, Maryland, Us

Responsible and accountable for generating, gaining governance approval, and executing integrated product development plans to time and budget using matrix resources provided from functional areas. Hired, trained, and supervised Director/Senior-Director level Product Development Team Leaders (n=3).• Led program for marketed pediatric anti-viral product to develop market support information and to successfully intervene in clinical practice guideline creating groups and payer’s efforts to restrict use in indicated population and to use untested treatment regimens. • Led anti-viral product through BLA prosecution, CRL submission, launch preparation, and FDA advisory committee conduct (including functioning as a moderator for Q&A session of the Advisory Committee). • Co-led Joint Product Development Team with co-development partner’s team leader. Team coordinated BLA and global dossier submission/responses across 2 companies and preparing for product launch globally. • Product Team Leader representative to RIA Innovative Medicine Team, involved representing product team perspective to disease area strategies, product profiles, development plans, trial designs, licensing and business development activities, and portfolio management activities. • Led multiple project teams for various monoclonal antibodies being developed for respiratory indications, including the highest priority project in the Medimmune portfolio. • Headed pulmonary due-diligence team on a large co-development deal resulting in licensing 5 biologics assets worth more than $1B• Steering committee member helping to drive process improvements using Six Sigma methodologies. The initiative significantly reduced study startup timelines and made processes more efficient.

DCPS is a pharmaceutical services consulting company, focused on providing drug development, clinical research, clinical pharmacology, clinical operations, and outsource management consulting services.• Clinical trial data analysis, clinical pharmacology plans, outsourcing process, and development team structure, function and implementation/training

Us

Corporate Officer for a biotechnology company with 2 development products. Responsible for all clinical and non-clinical development activities, chemistry manufacturing and controls, regulatory affairs, and corporate administrative operations (HR, IT, company administration). • Created product development plans, designed and executed clinical and non-clinical studies supporting the development plans, selected and qualified a contract manufacturing organization for product supplies• Involved in corporate fundraising (maintaining angel investments and securing Series A financing).

Chestnut Ridge, Ny, Us

Led Clinical Pharmacology and Clinical Operations for both branded and generic drug development projects, including management responsibilities for department staff (n = 4).• Led and was responsible for the clinical and clinical pharmacokinetic aspects of 8ANDAs, resulting in on-time submission and approvals• Prepared development plans, designed clinical trials, and led operational execution of Phase 2 and Phase 3 development for branded products, which included preparing and participating in FDA meetings, identifying and contracting CROs to execute clinical trials, and reporting progress to senior leadership• Alliance manager for a development partnership. Drove alignment between organizations on structure and responsibilities of development team, issues and communications management, and program oversight.

Stamford, Ct, Us

Clinical Operations: Created, staffed and led a global Clinical Operations Department (n =100). Responsible and accountable for all clinical study planning, budgeting, contracting, execution, monitoring, and summarization, medical writing, electronic publishing, and training and development • Created a novel computerized budget and resource model used to evaluate the portfolio and make strategic trade-offs based upon resource and budget limitations. • Sponsored and led a Project Management Office, tasked with reengineering all clinical development processes and systems, which led to improved quality and efficiency in clinical trial setup and execution.• Established operational metrics. • Responsible for developing and disbursing a ~$200M clinical development budget. Managed the overall development spend to within 5% of plan.Clinical Pharmacology: Led global Clinical Pharmacology and Clinical Pharmacokinetics Department, with responsibility for all Phase 1 and clinical pharmacology studies (including the quality of design and analysis) for ~15 projects in development. Accountable for the quality and timeliness of all Clinical Pharmacology Department deliverables (including protocols and study reports) supporting multiple global development programs. Accountable for Clinical PK and Population Modeling activities. Duties included management responsibilities for Clinical Pharmacology and Clinical Pharmacokinetics Department staff (n = 20), including physician and doctoral level clinical pharmacologists and pharmacokineticists.• Created, staffed, and supervised a Clinical Pharmacology Operations function, which was responsible for the planning, budgeting, executing, and monitoring all clinical pharmacology studies, • Assimilated Clinical Pharmacokinetics and Population Modeling functions into the Clinical Pharmacology Department,

Princeton, Nj, Us

Led Worldwide Clinical Pharmacology Department with responsibility for all Phase 1 and clinical pharmacology studies. • Project Director for a platelet adhesion inhibitor, responsible overseeing IND/INDS/CTX submission, clinical trials, and budgets. • Clinical Project Director for an in-vitro diagnostic device. Duties included overseeing, and summarizing trials for 510(k) submission, and budgetary oversight. • Study Directorclinical pharmacology studies for a platelet aggregation inhibitor/ vasodilator. Duties included designing and overseeing and summarizing Phase I studies and presenting pharmacology and clinical pharmacology aspect of the development program for an FDA Advisory Committee.

Princeton, New Jersey, Us

Responsible and accountable for the operations of a 48-bed CRU, including staff supervision (60 staff persons) and training, oversight of IRB activities, administration of all aspects of the recruitment, screening, and conduct of clinical trials, including transcription of data and research report writing. Responsible for ensuring the safety of subjects participating in studies conducted in the CRU. Responsible for designing Clinical Pharmacology Development Plans, reviewing and writing protocols and presenting Phase I studies to FDA.• Jointly responsible for P&L. Clinic had been losing money for the prior 18 months resulting from slowdown in business acquisition and increasing expenses. Turned around to a profitable clinic in 12 months by refocusing bids on more complex projects, altering patient recruitment methods and channels, restructuring clinic staff, training on quality, and reducing fixed expenses (layoffs and more efficient use of temporary staff).

New York, New York, Us

Clinical Scientist: Worked in Phase I, Phase II-III, and Phase IV Groups. Responsible for writing Clinical Development and Clinical Pharmacology Development Plans, designing and writing protocols, overseeing study execution, and summarization and publication of study results. Involved in safety, clinical and clinical pharmacology summary documents for regulatory submissions. • Involved in the preparation of documents for two NDAs, one ANDA, and two INDs, including presentations to the FDA and preparation for an FDA Advisory Committee. Major research projects were cardiovascular, specifically lipid regulating agents and ACE inhibitors. Clinic Manager: Responsible and accountable for the operation of a 16-bed CRU, including staff supervision (16 staff persons) and training, coordination of IRB activities, summarizing study safety results, and financial administration. • Led the acquisition of an integrated Phase 1 clinic electronic data acquisition/capture system.

Pharm.D.

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