Leadership/communication skills Five(5) or more years of industry, CRO

Nirmalya Banerjee MD, MHSA

***** **** *** *** **, Forest Hills, New York, 11375

C: 225-***-**** e: ************@*****.***

US Citizen

CAREER SUMMARY

Seeking to build a brilliant career as a Medical Director in Medical Advertisement/Communication with a reputed healthcare communication or advertising team, pharmaceutical, or research institution where my management skills, in depth knowledge of medical practices, clinical research, Healthcare-Medical Marketing and Strategic Communications can help in growth and development towards a strong Agency-Client liaison.

EXECUTIVE PROFILE SUMMARY

Visionary Operations Physician Executive with solid experience managing all levels of multiple projects including budgeting, advertising, communicating with healthcare administration, and versed in medical management, evidence-based practice and hospital-physician

Associate Medical Director with outstanding presentation, medical brand strategical implement and development, and communication and cross-cultural team management skills

Healthcare Administrator with better leadership, guidance and management in health systems to improve the quality of the work environment so that it provides a nurturing physical space for clinical staff, patients and families.

Associate Director of Clinical and Scientific Development contributing to, and implementing, the clinical strategy for the medical and pharmaceutical institution by leading and overseeing the tactical development of all clinical trial strategies

Accomplished educator with an adept at training both clinical and non-clinical audiences, promotional medical communications, medical students, and medical/research scientists.

An initiator and implementer who consistently exceeds target goals

Focused team leader who encourages creative problem-solving

Have High-energy, result-oriented leader with an entrepreneurial attitude.

WORK EXPERIENCE

M3 Global Research Sept 2015 - Present

Associate Director of HEOR in Clinical and Market Research

Confer with NIH, Mdlinx, practice manager, Doc-review, Doc Café and other research institution, research and scientific physicians, Educators and researchers to build streamlined value chains for reputed pharmaceutical and medical device companies

Provide useful information for licensing and R&D, as well as pricing and market access strategies, and will help to dictate research, planning and sales strategies.

Maintain extensive knowledge and analyzation of Value Development Plan (VDP) that is integrated into any HEOR strategy planned to be used as a core business function

Determine the benchmarks available alternatives in a therapy area based on clinical/economic value.

Identifies tactical outcomes research and economic model projects to demonstrate the clinical and economic elements, respectively, of the target value proposition.

Helps to inform and define the value communication strategy and tactics for relevant audiences.

Defines price ranges for products based on demonstrated value and addresses reimbursement and seamless market access.

Collective Primary Care Manhattan, NY

Associate Director of Operation and Clinical Laboratory/R&D/Senior Clinical Practice Director Dec 2013 – Aug 2015

Provide standardization of laboratory methodology for existing and future services using standard operating procedures.

Provide independent medical direction for ongoing and new business activities

Act as senior practice director on direct communication and collaborating with clients and developing content

Implemented and tested new methodology to maintain all in compliance with quality, safety, and other applicable procedures.

Mentoring, direct, quality control/quality assurance of junior staff members work (Associate Medical Director, medical writers, RNs, PAs, LPN, Lab techs etc)

Provided extensive knowledge in all medical aspects of publications including strategy, planning, and implementation.

Maintained up-to-date knowledge of important clinical issues, major publications, clinical practice guidelines, advancements, approved therapeutic drugs and regimens, therapeutic pipelines, and industry trends in the field of cardiology, respiratory, pulmonary, musculoskeletal, Gastrointestinal, pain and anesthetic, rheumatology, allergy and immunology, medical and radiation oncology to guide content development of CME/CE activities.

Member of Advisory panel of ACP, Internal Medicine, focusing on HTN, Hypercholesterolemia, COPD, Diabetes and Pulmonary Arterial Hypertension (PAH).

Manage staff, preparing work schedules and assigning specific duties.

Direct and coordinate organization's financial and budget activities to fund operations, maximize investments, and increase efficiency.

Establish and implement departmental policies, goals, objectives, and procedures, conferring with board members, organization officials, and staff members as necessary.

Operated in a highly-matrixed environment that relies on excellent team building, communication and coaching skills to optimize outcomes. Developed and implemented care teams in each practice site to meet the needs of population health management and patient-centered medical home.

Daily triaged patient health management, initiate outbound administrative requests, triage incoming and outgoing

medical calls, managed the medical practice of 15 health coaches, 4 lab with strong leadership and better organization

skills, and coordinate/supervise the performance of onsite phlebotomy on practice patients.

Independent Physician Association (Contract Medical Affairs) (CRO) Chicago, IL

Associate Medical Director/Medical Science Liaison (MSL)/HEOR specialist Aug 2009 – Nov 2013

Build and maintained solid and credible relationships with the medical community on company’s behalf in both Academic and Community settings, especially in Metabolics, Respiratory, Radiology, GI, Pain, Anesthetic, Neurology, Oncology, Rheumatology and Immunotherapy.

Maintained up-to-date knowledge of important clinical issues, major publications, clinical practice guidelines, advancements, approved therapeutic drugs and regimens, therapeutic pipelines, and industry trends in the field of Metabolics, Radiology, GI, Pain, Anesthetic, Neurology, and Oncology, Rheumatology and pulmonary, allergy and immunology (allergy and allergic reactions, COPD), Urology and Genitourinary, OB/GYN and other rare disease to update the CME/CE activities.

Some therapeutics:

Flexion Therapeutics: An Intra-Articular ER formulation of Triamcinolone Acetonide for Osteoarthritis of the Knee.

Pacira Pharmaceuticals: Exparel (Depofoam and Bupivacaine)

Eli Lily: Cyramza (ramucirumab); For the treatment of gastric cancer, Approved April 2014

Necitumumab, Portrazza, Evista (raloxifene hydrochloride) ;For the treatment of pulmonary arterial

hypertension, Approved May 2009

Evista, (raloxifene hydrochloride); for the treatment/prevention of osteoporosis and reduction of breast cancer risk in postmenopausal women, Approved September 2007

McKesson: Respiratory products like CPCP, BiPAP, Humidifier, vaporizer and Breathing apparatus

GSK: Breo Ellipta (fluticasone furoate and vilanterol inhalation powder); GlaxoSmithKline; For the treatment of chronic obstructive pulmonary disease, Approved May 2013. Ventolin HFA (albuterol sulfate inhalation aerosol); GlaxoSmithKline; For the treatment or prevention of bronchospasm, Approved April 2001

Pfizer: Aricept (Donepezil) for Fronto-temporal Dementia and Early Alzheimer

Xalkori (crizotinib); Pfizer; for the treatment of ALK+ non-small cell lung cancer, Approved August of 2011

Presentation and pharma symposium:

Sprout pharmaceutical: Addyi (new drug for hypoactive sexual desire disorder) Fibanserin is a new drug just got approved by FDA

Provide Clinical Research, Virology Research and Development, Customer Service, and various Sales and Marketing functions within the company

Build relationship with clinical investigators, influential physician opinion leaders in viral diseases including HIV/AIDS and Hepatitis, state and federal payer committee members, reimbursement analysts, and other allied healthcare professionals

Helped to ensure that KOL speakers have appropriate access to corporation’s data.

Participated in coordinating and conducting peer-to-peer interactions and medical presentations. Developed advance scientific, clinical and technical expertise in specific therapeutic areas.

As an expert in HEOR, provided useful information for licensing and R&D, as well as pricing and market access strategies, and will help to dictate research, planning and sales strategies. Other functions includes but not limited to, HEOR policies, compliance, NNI internal HEOR training, HEOR advisory board meetings, real world evidence (RWE) communication, budget management, people management, research review committee (either as the Chair or a key committee member), and collaboration with Global and NNI stakeholders.

Responded to unsolicited requests from investigators to conduct investigator-initiated research relevant to pharmaceutical products.

In response to appropriate requests, disseminated to physicians, nurses and other healthcare professionals’ state-of-the-art on-label research and medical concepts related to the treatment and management of diseases of interest to the company.

Relay Medical Information requests through appropriate channels. When appropriate, provided clinical and scientific support for pharmaceuticals at advisory boards, medical meetings and scientific congresses.

Executed and delivered all tasks and proven the ability to build relationships with the medical research community both internally and externally

Independent Physician Association (Contract Regulatory Affairs) (CRO) Chicago, IL

Associate Director of Regulatory Affairs/Regulatory Affairs Specialist Aug 2008 – Dec 2013

CMC (Chemistry and Manufacturing and controls) activities

Direct the preparation and submission of regulatory agency applications, reports, or correspondence.

Provide regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products.

Supervised and executed market landscape assessment, analyzing diverse market segments and providing recommendations on new market opportunities. Also provide expert input in the scouting and due diligence processes with market assessment, conception and financial calculations.

Liaison with DRA GPT (global project team) representative to plan and facilitate presentations to client regulatory boards on regulatory strategy.

Collaborated with DRA GPT representative to interact with regulatory consultants/advisors for global strategic input and challenge.

Developed and Implemented regulatory readiness with other line functions, Country Pharma Organizations and key opinion leaders, and ensures integration with global regulatory readiness with DRA GPT representative.

Reviews, approves and submits Clinical Trial Applications (CTAs) and Investigational New Drugs (INDs)

Responsible for safety issues from end of POC through life cycle management.

Review of medical safety input into study protocols (including MRC and OPCE) MAP, RAP and ICF.

Review/approve product-specific safety deliverables: IN letter, PGD, data searches, literature review, expert statements

Validate the submission to ensure compliance to US FDA requirements.

Review of global dossier summary documents

Executed and delivered all tasks and proven the ability to build relationships with the medical research community both internally and externally

Quality Assurances Activities

Prepare, review and execute SOP's (QA, clinical manufacturing, RA etc.)

Review method validation protocols, reports as per the USP<1225>, <1226> and <1227>

Review certificates of analysis (CofA's) and stability protocols and compilation (module 32p83)

Review and approve specifications of raw materials, in-process and finished products as per respective pharmacopoeias (USP/NF, EU)

Interfaces to negotiate and exchange information with all levels of management

University of Illinois Cancer Research Center (CRO) Chicago, IL

Drug Development Associate Physician/Drug Safety and Pharmacovigilance Physician February 2007-July 2011

Sub Contract with Eli Lily, Pfizer, GSK and Sprout

Oncology, CNS, Psychiatry, Immunology, Respiratory, Pain and Anesthetic Therapeutic Areas

Drugs: Methotrexate, Adriamycin, Gemcitabine, Taxol, Taxane, Jevtana, Veramix, Xeljanz, Cervarix, Lyrica, Chantix

Assesses the relationship between drugs and adverse events

Identifies product value proposition from a clinical perspective, though critical analysis and interpretation of literature

Handle responsibilities of reviewing and processing adverse events reported by investigators.

Provided extensive (90%) Medical Review of individual safety case reports

Participated and developed protocols in the training of the Safety Specialists and Coordinators

Involved in co-authoring of protocols, clinical study reports and CTD Sections.

Work closely with CROs and Regulatory Affairs staff to provide medical leadership and scientific guidance both internally and externally.

Responsible for providing medical and scientific information to health care professionals.

Evaluate research and pipeline products for Proof-of-Concept and GO/NO GO decisions based on solid assessment of potential for development and resource needs.

Perform the tasks of reviewing bioequivalence study protocols, clinical trial protocols, and provide support to the sub-group of health care professionals, and other clinical trial team.

Handle responsibilities of developing concise, accurate and well-written case narratives.

Perform the tasks of maintaining the safety database and perform coding of diseases as well as adverse events according to the project-specific coding conventions.

Responsible for making presentation of safety process at clients and investigator meetings

University of Illinois (CRO) Chicago, IL

Principle Investigator in Phase I and/or Phase II and/or Phase III and/or Phase IV studies for Multiple Therapeutics and Various Oncology condition/R&D Jul 2006 – Jul 2009

Conduct research to develop methodologies, instrumentation and procedures for medical application, analyzing data and presenting findings.

Plan and direct studies to investigate human or animal disease, preventive methods, and treatments for disease.

Teach principles of medicine and medical and laboratory procedures to physicians, residents, students, and technicians.

Standardize drug dosages, methods of immunization, and procedures for manufacture of drugs and medicinal compounds.

Managed 25 employees (junior scientists, managers, Operation assistants, NP, PA, CRA, CRT, Laboratory team) and overall directed over 110 employees in the hospital as an Associate Medical Director.

Investigate cause, progress, life cycle, or mode of transmission of diseases or parasites.

Maintain up-to-date knowledge of important clinical issues, major publications, clinical practice guidelines, advancements, approved therapeutic drugs and regimens, therapeutic pipelines, and industry trends in the field of cardiology, respiratory, pulmonary, musculoskeletal, pain and anesthetic, rheumatology, allergy and immunology, medical and radiation oncology to guide content development of CME/CE activities.

Confer with health departments, industry personnel, physicians, and others to develop health safety standards and public health improvement programs.

Perform the tasks of conducting research and analyzing medical and scientific literature

Responsible for providing medical and scientific information to health care professionals

Perform the tasks of reviewing bioequivalence study protocols, clinical trial protocols, and provide support the clinical trial team

Member of Advisory panel of ACP, Internal Medicine, focusing on HTN, Hypercholesterolemia, COPD, Diabetes and Pulmonary Arterial Hypertension (PAH).

Member of Advisory panel of ASOC, Oncology and Radiation Board, focusing on Lung Cancers, Musculoskeletal and other Bone Cancers with various treatments with chemotactic therapeutics.

Neurology Associates: Emory Medical Center Fayetteville, GA

Associate Medical Director/Clinical and Research Physician/R&D/Managed Care/Presenter April 2003 to June 2006

Presenter and clinical researcher for Neurodegenerative Disorders, Movement disorders, Parkinson Disease, Alzheimer’s and fronto -temporal dementia, stroke and seizure disorders.

Primary focus on Aricept, Namenda, Carbidopa l-Levodopa, Rytary, other anti-depression medications.

Conducted Electromyography (EMG) with focused myogram study and interpretation.

Nerve conduction study focusing the triggering points and the neuromuscular conduction rhythm.

Headache and sleep study focusing mainly on Sleep Apnea and maxilla-mandibular Advancement.

Dispersing different therapeutics for various neurological disorders under supervision of chief physician.

Developed a multi-disciplinary environment for the clinic and the future clinics with the management team.

Published Scientific and Clinical Methodology, protocol design, project management and regulatory

requirements for clinical studies.

Medical development of therapeutics for Multiple Sclerosis and other related Neurological therapeutic areas.

Chart analysis/clinical documentation for clinical conditions and procedures in a specialty care center

Brought down patients' complain by 65% by enacting a proper health care system

Instrumental in reducing paper works and digitizing process

EDUCATION

ST, JOSEPH'S UNIVERSITY Philadelphia, PA

May 2015 - Present

MBA in Pharmaceutical and Health Management

UNIVERSITY OF ILLINOIS SCHOOL OF MEDICINE Chicago, IL

Jul 2006-Jul 2009

Post Graduate Training: Resident in Internal Medicine

CENTRAL AMERICAN HEALTH SCIENCES UNIVERSITY Belize City, BZ

Sep 2001-Apr 2005

MD Doctor of Medicine

ST. JOSEPH'S COLLEGE Standish, ME

Jan 2002-Jul 2004

MHSA Master in Health Sciences Administration

SOUTHERN UNIVERSITY Baton Rouge, LA

May 1999

BS in Biology and Chemistry

FACULTY POSITION

Teaching Assistant- Dept. of Internal Medicine

July 2006-July 2007

University of Illinois, Chicago, IL

Assistant Clinical Professor- Dept. of Neurology and Psychiatry

August 2007- September 2008

University of Illinois, Chicago, IL

Assistant Clinical Professor- Dept. of Oncology and Hematology

August 2008 to September 2009

University of Illinois Chicago, IL

CERTIFICATION

BC in Internal Medicine ABIM

BC in Neurology

BE in Oncology

Cpt (Certified Phlebotomist): Expires in June, 2018

CPR ACLS and BLS Expires June, 2016

IFM Certification from July 2006 - July 2010 Expired August 2010

NPI: 151*******

ADDITIONAL SKILLS

Leadership/communication skills

Five(5) or more years of industry or clinical trial experience

Five (5) yeas of industry or clinical regulatory affairs experience

Self-motivated

R&D in multiple therapeutics/Clinical Research

CRA and CRT expert

Conduct clinical monitoring of sites, testing articles, human projects and protocols

Understanding of applicable FDA regulations and current GCPs.

GCP/ICH Trained Market research and clinical analysis

Understanding of the current industry guidelines (CMJE, GPP2, Sunshine Act)

Medical Writing/Promotional Medical Education

Medical Communications

Efficient in Paragon and Epic EMR usage

HIV/AIDS and Other Hepatitis including Viral Diseases

HIPAA Rules and Regulations and protocol execution

HEOR Background in Research and Efficacy Studies

Expert in MOD and product MOA

Regulatory and Safety Strategy

Expert in ICD-9 and ICD-10 coding

Knowledge in CPT

Strategy and Protocol Development

Employee relations/Negotiations expert

Business operations organization

Sales and Marketing Support

Scientific and clinical methodology, protocol design, project management. Knowledge and understanding of Interdependencies of various preclinical, clinical, regulatory and commercial disciplines

Assessment and processing of adverse events received from healthcare professional and consumers

Budget modeling, epidemiology modeling, experience creating HTA submissions and global value dossiers, and strong insight into the payer space

Mac Yosemite and Windows 7,8,10 skilled

Office 2010 and Adobe expert

Fluent in English, Hindi, Bengali, and some in Spanish and French

RESEARCH

Life Extension Foundation: 2010-2015

Clinical trial measuring the effectiveness of Magnesium Sulfate infusion on treatment-resistant depression patients.

Clinical trial to assess the effects of coffee in support of cognitive, metabolic and immune health in individuals with subjective memory complaints.

A phase II clinical trial investigating DCA, short for Dichloroacetic acid, for individuals who have stage IV cancer with solid tumors or prostate cancer and have failed conventional or investigational therapies, with limited options for further therapy.

Clinical trial using vitamin D cofactor called Gc macrophage activating factor (GcMAF), LEF is exploring further clinical investigation into its additive or synergistic effects when used with dichloracetate (DCA).

Insulin, chemotherapy, and the mechanisms of malignancy: Clinical Study at Autonomous University of Baja California, Tijuana, B.C. 2008-2010

Low-Dose Chemotherapy with Insulin (Insulin Potentiation Therapy), Clinical Study at University of Illinois Chicago, Chicago, IL 2007-2009

Major Responsibilities and Functions:

Principle Investigator 2006-2008

Phase I and/or Phase II and/or Phase III and/or Phase IV studies for the following drugs and Orthopedic Oncology condition:

Chondrosarcoma, Osteosarcoma, Synovial Sarcoma, Liposarcoma, Adriamycin, Methotrexate

Principle Investigator 2008-2010

Phase I and/or Phase II and/or Phase III and/or Phase IV studies for the following Multiple Oncology conditions:

Chondrosarcoma, Osteosarcoma, Non-Small Cell Carcinoma of Lung and Small Cell Carcinoma of Lung, Prostate Carcinoma, Breast Carcinoma

NIH Research Foundation: 2007

Safety, Efficacy, and Treatment Satisfaction Switching From Flolan to Remodulin Using the Crono Five

Ambulatory Pump in Patients with PAH: Immunology Research: United Therapeutics: NY Presbyterian

Hospital: Research Terminated.

PUBLICATIONS

Fischer, OM, Hart, S., Prenzel, N., Banerjee, N., and Ullrich, A. “Oxidative and osmotic stress signaling in

tumor cells is mediated by ADAM proteases and heparin-binding epidermal growth factor”. Molecular Cell

Biology: vol. 12. 5172-83. June 24, 2004

Zoschke, D.C., Staite, N.D., and Banerjee, N. "Suppression of human lymphocyte proliferation by activates

neutrophils or H202: Surviving cells have an altered T Helper/T Suppressor ratio and an increased resistance to

secondary oxidant exposure". Clinical Journal of Immunology: Immunopathology. 160-170, February 2002.

Ciardiello F1, Caputo R, Bianco R, Damiano V, Pomatico G, Banerjee, N., De Placido S, Bianco AR, and Tortora

G., "Antitumor effect and potentiation of cytotoxic drugs activity in human cancer cells by ZD-1839 (Iressa), an

epidermal growth factor receptor-selective tyrosine kinase inhibitor". Clinical Cancer Research: vol.6 2053-63,

May 06, 2000.

ACTIVITIES AND VOLUNTEER

American Red Cross: Volunteer for Clinical Physician during Hurricane Katrina Disaster Relief New Orleans, LA 2005-2007

American Medical Association: Volunteer at Belize Health Project: http://belize.peacecorps.gov/content/rural-family-health-project Belize City, BZ 2000-2002

Baton Rouge Green: Volunteer service for the Eco Relief Project: Baton Rouge, LA 1997-1999

Baton Rouge General Medical Ctr. Volunteer Inpatient/ Outpatient in the Department of rehabilitation

600 hrs. Baton Rouge, LA. 1993-1994

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