Muhammad Zahid M.D., MPH, CIP

• Chaired Oncology board meetings dedicated to review phase-1 & 2 oncology protocols and amendments. • Chaired board meetings dedicated to review protocol and consent form amendments. • Served as a primary physician reviewer and presented countless new protocols, protocol and consent form amendments, unanticipated problem reports, IND Safety reports and, non-compliance related issues • Served as a scientific reviewer for board meetings particularly dedicated to review complex site and investigator related issues. • As an expedited reviewer, reviewed new studies that fall under minimal risk categories. In addition, was responsible for reviewing, minor protocol and consent form amendments, dear investigator letters, protocol clarification letters and site related issues through expedited review. • As a physician safety consultant, regularly reviewed unanticipated problem reports, IND safety reports, SAEs, Investigator Brochures, Annual product safety reports, Interim analysis findings, DSMB reports, major protocol deviations, publications, FDA audit reports, FDA form 483, Sponsor audit reports and Investigators medical license and conduct related issues

Clinical Affairs/Research Accomplishments: • Co-developed clinical decision support system for chronic conditions, oncology, infection control, medication management and disease registries. • Co-developed severity and care gap scores for most common chronic diseases. • Co-authored white papers on Tele-health monitoring program for diabetes mellitus, heart failure and COPD. • Mentored and trained physicians regarding reviewing and critically appraising medical literature, grading evidence and citing references. • Represented Alere as a speaker and expert panelist of population health and data analytics in international conferences and national forums, such as CMIO Conference and eHealth Forum Leadership / Operational Accomplishments • Flourished a Culture of Excellence among cross functional global teams, which resulted in culture of transparency, open communication, knowledge transfer, peer support, collaboration and teamwork. • Visioned, defined, and implemented three tiered, data driven, management methodology which significantly improved efficiency and quality of work during process of clinical discovery. • Developed Standard Operating procedures and Best Practice Guidelines to streamline operations across cross functional global teams. • Resolved most difficult to control, complex problems, by using analytical approach which assured timely delivery of projects. • Hired and supervised more than 50 direct report employees working globally at different geographical locations and managed their assignments, reviews, salaries increase and promotions. • Led clinical team daily meetings to proactively identify risks, bottlenecks and roadblocks and timely addressed their resolutions and adjusted staff assignments and resources according to the changing priorities and projects workload. • Visioned and implemented a companywide system to improve processes across the entire organization which significantly improved efficiency and quality of work.

• Directed and executed clinical trial activities in accordance with Asthma Research Center SOPs, ICH, and Good Clinical Practice (GCP) Guidelines. • Built and led cross functional clinical project teams and effectively managed Phase I to Phase IV studies. • Trained study physicians, project managers, study coordinators, research assistants in executing research procedures as per protocol and regulatory requirements. • Successfully planed and managed study staff resources and helped in hiring and interviewing new study staff. • Assured timely collaboration with external Clinical Project Teams including Data Management, Drug Supply, Regulatory Affairs and Pharmacovigilance teams. • Managed CRO relationship to ensure the appropriate scope of work, oversight and training of clinical investigators and achievement of study milestones within agreed upon time, budget and quality. • Presented clinical studies performance data to members of the management and scientific teams. • Developed protocols, Data and Safety Monitoring Plans, Manual of Study Procedures, Informed Consent Documents and CRFs and assisted the study team in the process of IRB submissions and approvals. • Managed the operational components of the clinical trials in its entirety including planning, resourcing, timelines, quality control, and budgetary management. • Liaised with other clinical sites to resolve administrative issues and answer questions regarding scientific, regulatory, and safety-related issues. • Provided guidance during process of Investigational New Drug (IND) applications and approvals. • Improved efficiency and effectiveness of the Human Research Protections Program at Partners IRB and assisted in AHRPP accreditation process through interviews. • Submitted study progress, safety, and interim analysis reports to Data Safety Monitoring Board and NIH scientific officer and assured implementation of recommended changes across all study sites.

• Reviewed protocols, informed consent documents, data and safety monitoring plans, and other pertinent study material involving human participants and documented findings regarding ethical considerations, scientific merit, and adherence to federal regulations and IRB policies and procedures. • Attended assigned Board meetings, conducted presentations and participated in relevant discussion during Board meetings. • Acted as a subject matter expert in pulmonary medicine and pediatrics. • Regularly completed continuing education requirements set by the institution. • Reviewed research activities to ensure that risks to subjects are minimized and reasonable in relation to anticipated benefits. Ensured that the selection of subjects is equitable, informed consent is appropriately obtained, and the subjects' privacy and confidentiality are protected. • Conducted continuing reviews of approved research. Reviewed proposed amendments, adverse events, unanticipated problems, protocol deviations, and matters of non-compliance. • Voted on each item presented to the Board, providing justification as necessary • Determined if and when the research will require progress reports. • Audited and/or monitored the research and researchers for adherence to the federal regulations and IRB policies and procedures.

I investigated the effectiveness of Tiotropium bromide and clarithromycin in the treatment of sub-optimally controlled asthma in two separately conducted trails. In addition, compared Physicians, Biomarkers, and Symptom-Based Strategies for adjustment of Inhaled corticosteroid dose in adults

Helped in initiation and establishment of a new research section in a geriatric group practice. Wrote SOPs and manual of study procedures and conducted study visits, performed procedures, dispensed medications, scheduled follow up visits and maintained study documents and coordinated with the data coordinating center and study sponsor. Assured protocol and regulatory compliance and timely reporting of adverse events to the appropriate regulatory authorities during conduct of clinical trials and maintained quality and integrity of study data.

Graduated with honors Chancellor Award, On Deans List