Syed Alamdar Rizvi, MS

McHenry, IL

Email: ad1m8i@r.postjobfree.com Phone: 630-***-****

https://www.linkedin.com/in/alamdar-rizvi-ms-summa-cum-laude-466347110/

Summary of Experience:

Pharmaceutical and clinical research professional with 25+ years of experience. 3+ years of experience as VP Clinical Affairs group overseeing all clinical management activities for an AI driven medical device company. Over 8 years within R&D from concept to launch. 18+ years of Clinical Research industry experience, 10+ years of Clinical Monitoring experience, 8+ years of Clinical Project Management experience (both US and International) overseeing all phases of clinical research trials with proven management and leadership skills while mentoring junior CRAs as well as all on-site monitoring activities for various clinical studies. Have successfully led and completed 12 Phase I studies, 11 Phase II studies, 7 Phase III studies, and 4 Phase IV clinical research studies with vendor management and oversight responsibilities. Have managed multiple, ongoing Phase I, II, and III trials covering the following therapeutic areas within Clinical Operations; Oncology (bladder, melanoma, non-small cell lung, prostate, liver, colon, breast), Cardiovascular, Bleeding Disorders, Pain Management, Depression, Diabetes, Infectious Diseases, Neurologic, Women's Health, and Alzheimer's. Extensive experience with Medidata RAVE, CTMS, iMedNet, Impact, Inform, and MS Project. In-depth knowledge of GCPs, ICH guidelines, and FDA regulations. Represented company and presented at on-site FDA meetings. Possess outstanding written/ oral communication skills and proven techniques to effectively manage several studies across multiple projects while maintaining clear communication lines with upper management reporting responsibility.

Professional Experience:

4/22-4/23 Kelly Services assigned to Janssen (J&J)

Global Trial Leader, Medical Affairs- Oncology

Independently managed key Phase II global oncology trials with multiple sites reporting overall study management progress to leadership team

Management oversight responsibility of CROs and external vendors

Successfully took over and seamlessly transitioned two key clinical trials from outgoing clinical manager without impact to project milestones.

Collaborated with Sr. Managers to identify vendor selection, patient recruitment/ retention strategies, as well as site selection activities

05/18-2/22 Laboratory for Advanced Medicine Inc., West Lafayette, IN

VP of Clinical Affairs

●Provide companywide strategic leadership to the Global Clinical Operations Team and work directly with the Chief Regulatory Officer to assist in leading all FDA Clinical Trial management efforts globally for successful launch of key Oncology FDA Clinical Trials including enhancements pipeline for various cancer research programs.

●Serve as lead contributor and direct interface with FDA alongside Chief Regulatory Officer representing the Clinical group at key submissions meetings with the FDA as well as CMS for reimbursement for the Company

●Work directly with Leadership Team (CEO, Chief Regulatory Officer, CMO, CTO, and CFO) to advance key initiatives, promote commercialization efforts, and manage all Clinical Affairs programs for the Company

02/17 – 1/18 Advanced Clinical assigned to Allergan

Global Clinical Management Operations

Sr. Regional Site Manager III

●Oversee and conduct research clinical trials/ monitoring for 26 key clinical sites throughout the US for Global Clinical Operations team maintaining global projects for a variety of therapeutic areas, such as IBD, FC, Neurologic disorders, Uterine Fibroids, and several Depression studies for both adult and pediatric populations

●Independently managed multiple sites for various clinical studies with monitoring responsibility from site qualification to site closeout visits and overall study management progress

●Overall responsibility for CROs/ vendors and all operational activities of the clinical studies, from start-up through monitoring for multiple therapeutic areas in a matrix environment.

●Successfully took over and seamlessly transitioned several sites from outgoing Sr. CRAs as well as all on-site monitoring activities for clinical studies without impact to project milestones.

●Collaborated with Sr. Managers to identify vendor selection, patient recruitment/ retention strategies, as well as site selection activities

10/15 to 01/17 Real Staffing assigned to Pfizer

Global Established Pharmaceuticals- Clinical Operations

Clinical Project Manager III

●Provided strategic leadership to the Global Clinical Operations/ Global Established Pharmaceuticals Management Group maintaining global projects, and enhancements pipeline for various clinical programs/ projects

●Independently managed multiple sites for various clinical studies with monitoring responsibility from pre-study visits to a site close out visits

●Overall responsibility for CROs/ vendors/ US and OUS clinical site contracts and all operational activities of the clinical studies, from start-up, monitoring, through clinical study report (CSR) completion for multiple therapeutic areas in a matrix environment.

●Supervised in-house CRAs as well as all on-site monitoring activities for clinical studies.

●Served as the primary interface for vendor selection, patient recruitment/ retention strategies, as well as budget negotiations with outsourced vendors

4/15 to 10/15 Baxter Healthcare Corporation Round Lake, IL

Medical Products- Project Management Organization

Project Manager, Premix Drugs and Oncology

●Provided business and technical leadership for several projects/ clinical studies under the Project Management Organization including planning and coordination of projects

●Utilized MS Project to monitor, coordinate, and manage all research and clinical activities required to support the projects portfolio and maintenance of all premixed drugs and Oncology products for the division

●Managed and coordinated core meetings with key stakeholders by core/cross-functional teams to ensure continued on-time delivery of products while maintaining projected forecasts and future distribution plans for plants

●Accountable for core team performance, project schedule and execution, budget commitments and spend

●Led core teams in defining project strategies, developing goals, and ensure project scope is defined and controlled

●Continuously interacted with all functions and levels of management ensuring effective ongoing communications across teams and stakeholders

●Ensured identification and communication of project risks within the core teams and drove proactive management of risk response strategies

8/14 to 3/15

2/14 - 8/14

5/13 - 2/14

4/12 - 4/13

7/10 - 4/12

InVentiv Health – Assigned to AbbVie Abbott Park, IL

Clinical Project Manager

●Assisted Program Manager in planning, management, and execution of one or more clinical studies

●Assisted with Management of CFO and vendors such as CRO’s, Central Lab, and other suppliers

●Performed matrix management of functional area leads to meet study deliverables

●Coordinated study activities such as study design, protocol preparation, investigator selection, investigator meetings, contract preparation, vendor selection, CRF design, as well as other clinical project activities to ensure on-time completion of studies

●Supervised in-house CRAs as well as all on-site monitoring activities for clinical studies

●Identified, assessed, and successfully managed any critical site issues with potential impact on evaluable study data, ethical study conduct, and ICH compliance to ensure seamless study execution and on-time deliverables and milestones met

●Effectively communicated study information and escalation of issues to upper management team

●Proposed corrective action plans and contingency plans

●Assisted in development and management of the study and/or site budgets with Clinical Procurement Research Management team

Quintiles Corporation, McHenry, IL

Senior CRA III, Global Clinical Operations

●Management responsibility of over 24 sites across multiple protocols within Neuromodulation studies for Parkinson’s Disease, Headache Disorders, and Pain Management

●Direct mentoring and oversight responsibilities of junior CRA staff

Abbott Molecular, Des Plaines, IL

Clinical Project Manager, Clinical Affairs

●Overall management responsibility for the key in vitro diagnostic clinical study projects

●Designed, implemented, and monitored clinical studies of new and modified in vitro diagnostic Products, for indication of NSCLC, Melanoma, and Bladder cancers, with all responsibilities including managing budgets, contracts, and vendors

●Ensure that the clinical studies are conducted per established procedures, policies, GCPs

●Participated in preparation of regulatory submissions and international registrations

●Managed large, complex projects and/or several smaller projects, with direct reports

●Conducted Initiation, Interim, and close out visits at clinical study sites for projects

●Direct mentoring and oversight responsibilities of Senior CRA staff

Contract Assignment with Takeda Global Research & Development Center, Inc.

Senior Clinical Trial Manager, Clinical Operations

●Contributed to protocol synopsis development and to Clinical Development Plan (CDP)

●conducted global Phase 1 clinical studies with vendor oversight

●Actively conducted Initiation, Interim Monitoring, and close out visits at clinical study sites while in a management role

●Led in the evaluation and selection of all vendors for assigned studies.

●Responsible for managing assigned study(ies) within budget; provide the latest best estimate of study budget according to Company processes; provides guidance to study team on changes to study budget

●Participated in the evaluation and selection of study sites/investigators in collaboration with the Program Manager

●Coordinated study-related meetings and provided protocol-specific training to investigators, clinical site personnel, monitoring staff and/or vendor personnel

●Assisted in the design/ review/ and development of case report forms (CRFs), CRF guidelines, study manuals, data management edit checks, and data collection tools to ensure that they adhere to protocol and Company standards

●Maintained project tracking system with current study status and provided accurate progress reports

Baxter Healthcare Corporation, Bioscience, Deerfield, IL

Clinical Project Manager

●Served as Interim Project Manager for a multi-center global Phase 3/ 4 Hemophilia randomized surgery trial and took over study management responsibility in the US and also managed another key Phase I study

●Actively conducted routine monitoring visits, including initiation, interim, and close out for a number of clinical sites across two protocols

●Conducted and led US Investigator/ CRO/ CRA training including comprehensive protocol review

●Utilized CTMS for multiple projects tracking and reports management tools

●Completed CTMS Study Manager Training Courses including Productivity Changes Release Training

●Led Request For Proposal (RFP) process for central labs, CRO, and recruitment vendors for key Baxter’s Top Project

●(also includes responsibilities listed below)

●Trained and supervised in-house CRA staff

4/7 - 7/10

Contract - Assigned to Baxter Healthcare Corp., Bioscience, Deerfield, IL

Senior CRA

●Managed all aspects of initiation of a key phase I clinical study, including management of the CRO activities, protocol development, initiation of contracts/ budgets w/ vendors, Core Labs, ICF Template development, site selection/ start-up, DSMB/ CEC oversight, IRB submissions, planning and coordinating Kick-Off and Investigator Meetings

●Served as Clinical Study Team Lead in management/ oversight activities of key Phase II stem cell trial w/ planning and coordination of Ad Board and expert panel meetings as well as planning/ projected enrollment timelines/ budgets and all start-up activities for potential pivotal (Phase III) trial for Chronic Myocardial Ischemia (CMI)

●Provide oversight and assist in Management of key recombinant VWD trial, serving as the lead Sr. CRA for all US sites and actively monitoring clinical sites in a global super BTP Phase II study- one of Baxter’s top initiatives

●Effectively address FDA issues/ concerns throughout the conduct of the clinical trials

●Develop clinical strategies and project plan to efficiently manage the project and maintain regulatory compliance

●Reviewed contracts/ budgets/ and conducted CRO oversight to ensure appropriate management of the trial

●Utilized CTMS for multiple projects tracking and reports management tools

●Managed Clinical Application Specialists in the development of training and monitoring plans for Batch Record production and retrieval

●Initiated and chaired the first Global CRA meeting within Baxter Bioscience promoting innovation, growth, and development across regions for Clinical Operations

●Participated at Investigator Meeting for a Phase IIb Global Mesh Graft biosurgery study as a potential trainer for use of Easy Spray Device at Clinical sites

●Assisted in budgets/ planning for upcoming Hemophilia trial and related sub-studies

●Served as primary contact with Global Pharmacovigilance for the Clin Ops team ensuring harmonization of Safety processes/ SOPs are successfully achieved

●Served as a backup to assist and support the Sr. Clinical Project Manager, as needed including training and supervising over junior in-house CRA staff

1/06 - 4/07

Contract assigned to Kendle International, Northbrook, IL

Senior CRA III

●Completed project activities associated with monitoring functions of Phase I-IV clinical research studies while continuing to develop knowledge of drug development processes, GCPs, ICH, and relevant FDA regulations

●Responsible for management/ oversight of 22 clinical trial sites for various ongoing Phase I through III studies in the areas of prostate cancer, Osteoarthritis, and Diabetic Neuropathy

●Provided clinical and technical support for CRA I/ CRA II including relevant training and overview of the project(s) as needed

●Performed management of study site activities to ensure the integrity of clinical data, in adherence to all applicable regulatory guidelines SOPs and Project Specific SOPs are met

●Participated and presented as CRO representative at key Investigator Meetings for various sponsor led trials

●Assumed the role of Lead CRA on projects as needed

10/04 – 12/05

Pharmaceutical Resource Corporation (PRC), Hatboro, PA

Senior Clinical Research Associate (10/04 – 12/05)

●Trained and mentored junior CRA staff while independently training study coordinators/ investigators on all aspects of the protocol(s)

●Represented PRC in the pharmaceutical industry, medical research community as a primary resource for site personnel and the research project team and developed collaborative relationships with investigative sites and Sponsor clients

●Independently evaluated and recommended selection of investigators/ study sites

●Managed all aspects of clinical trial monitoring from Pre-Study through Closeout for multiple Clinical Research projects at various phases and in a variety of therapeutic/ medical research areas, including, but not limited to, Diabetic Neuropathy, AIDS/ HIV, Urology, and Oncology (Prostate Cancer), in accordance with ICH/ GCP guidelines.

01/04 – 10/04

Baxter International – Cellular Therapies, Round Lake, IL

Regulatory Affairs Associate III (01/04 –10/04)

●Responsible for overseeing all international import/ export regulations for the Cellular Therapies Division of Baxter International - multiple marketed products across multinational countries throughout the world.

●Responsible for all IND Submissions, Master Files, and annual reports supporting all divisional products marketed by Baxter through the Cellular Therapies Group

7/00 – 1/04

Baxter International, Transfusion Therapies Pathogen Inactivation, Round Lake, IL

Clinical Research Associate II/ III

●Primarily responsible to oversee CRO activities, data management while

●serving in the capacity as the lead CRA ensuring conduct and development of all Processing activities for the Phase III Red Cell Clinical Trials (both Acute and Chronic patients) for Pathogen Inactivation in North America, including management of 2 full-time contracts CRAs for the study

●Ensured completion of all monitoring/ auditing activities for the Platelet Phase III Clinical Trials as well as RBC Trials, while managing all duties and responsibilities as described under Clinical Research Associate I experience

01/99 – 7/00

Baxter International, Fenwal Division, Pathogen Inactivation, Round Lake, IL

Clinical Research Associate I (01/04 –10/04)

●Responsible for assisting, coordinating, and monitoring the conduct of all aspects of global Clinical Trials for key Phase III Clinical Studies for both acute and chronic leukemia patients (AML, CLL, sickle cell and thalassemia), for transfusion therapies

●Prepared and executed Clinical Research protocols, summaries, and final reports to meet FDA and other agency requirements

●Developed effective training tools for both CRA’s and Site Coordinators as well as performing site evaluations through closeout visits and clinical audits

●Prepared project status/ quarterly site updates, identified data trends, analyzed and interpreted study data, managed timelines for sites, independently provided training for investigators/ study coordinators and site personnel

10/94 – 12/98

Baxter Healthcare Corp./ Fenwal Division, Round Lake, IL

Research Scientist (10/94 –08/99)

●Responsible for coordination and supervision of all aspects of in vitro GLP studies for global regulatory submissions including supervision of two full-time Physiologists

●Managed all aspects of blood physiology labs, including, preparation,

●designed and conducted large and small-scale physiology studies in support of Pre-Clinical trials, including review, preparation, design, and execution of research protocols and final reports providing engineering support in all phases of Clinical/ and non-Clinical studies.

06/92 – 10/94

Abbott Laboratories, Abbott Park/ NC, IL

Research Analyst (04/93 -10/94)

●Designed and conducted a variety of GLP, GMP studies, both lab scale and in production to implement a new drug development process.

●Operated and maintained instrumentation systems for retrovirus labs

●Conducted enzyme immunoassay studies designed to test HTLV/ HIV antigens on polystyrene-coated beads; evaluated/qualified multiple lots using both manual and automated systems under assay development

●Communicated and maintained effective liaison with several departments and groups to streamline the implementation of a new freeze-drying technique for a new parenteral drug

●Implemented a highly effective filtration system into a manufacturing plant to eliminate impurities for a pulmonary lung surfactant for premature infants

PROFESSIONAL MEMBERSHIPS

American Association for the Advancement of Science – since 2000

American Association for Clinical Chemistry – since 2003

EDUCATION

Jan. 2008

M.S. – Summa Cum Laude – Applied Immunology

Dartley University, Wilmington, DE

1992

B.S. -Biochemistry

University of Illinois, Chicago, IL

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