== PHYSICIAN EXECUTIVE, CLINICIAN SCIENTIST, MEDICAL SCIENTIFIC ADVISOR ==
Dynamically articulate Medical Doctor (MD), trained Family Physician (MRCGP-INT training completed), Clinician Scientist/Researcher (MSc, PhD) and Business Director (MCS, MBA), with Clinical Development, Medical Affairs & Commercialization experience in multiple therapeutic areas in academic, large corporate and start-up environment.
14+ years of hands-on experience in the fields of General Family medicine, Mental health, Psychiatry, Sleep disorders and Genetics.
Unique multifaceted expertise in Clinical medicine, Clinical Research Project Management (academic and/or industrial clinical trials), Drug Safety and Pharmacovigilance, Clinical Research Data Management and Analysis, and Scientific/Clinical/Medical Training.
Proficiency in Medical Advising, Medical Writing and Medico-marketing.
Skilled in providing scientific input into brand plans, product positioning, marketing strategies, and product launches.
Experienced in contribution & review of product promotional material and providing strategic input to product labeling process.
Specialties:
- Medical Doctor (MD) Qualification.
- Postgraduate training in Family Medicine.
- Postgraduate training in Pharmaceutical Medicine.
- MCS Health Informatics.
- MBA General Management/Marketing.
- MSc Psychiatry.
- Grad. Cert. Sleep Medicine.
- PhD Neuroscience/Psychiatry/Genetics.
Medical Director – Scientific Affairs and Research Development @ Summary: Working as Medical Director – Scientific Affairs and Research Development at PPRI, PPG. This role entails functioning as researcher, educator, and provider of clinical scientific advice. Responsible for defining the strategic direction for Clinical trials, Pharmacogenomics and Neuromodulation research streams. Providing leadership in management of staff responsible for coordinating clinical trails of innovative technologies and therapy modalities in multiple sites working with a variety of medical professionals. Managing operational and logistical tasks to ensure efficient execution of all scientific and clinical projects related to Clinical trails, Neuromodulation and Pharmacogenomics within established budgets and timelines, ensuring all activities occur in compliance with the appropriate regulations, including FDA regulations, IDE, 510 (k) guidelines etc.
Responsibilities:
- Acting as the Co-Principal investigator and overseeing clinical trials, providing support towards training the clinical sites to the protocol, and aiding in regulatory submissions.
- Developing protocols, research procedural manuals, adverse event reports, institutional review board documents, and progress reports.
- Responsible for hypothesis formulation, research, data analysis and interpretation for publishing manuscripts influencing current diagnostic and therapeutic guidelines.
- Developing and implement SOPs for clinical trials and related activities, ensuring compliance with all applicable regulatory standards related to global clinical trials and interactions with physicians.
- Developing and maintaining professional relationships with academic and community-based physicians, clinicians and investigators to assure good clinical input to Pharmaceutical, Pharmacogenomics and Neuromodulation clinical trials. From February 2014 to October 2015 (1 year 9 months) Medcial Science Expert Speaker - Medical Vlog "Bench to Bedside" & Other Media @ Summary: Functioning as a key Medical Science Expert Consultant and Speaker for Health Awareness & Disease and Management. From February 2014 to October 2015 (1 year 9 months) Consultant Medical Director – Transcranial Magnetic Stimulation (TMS) Medical Device Franchise @ Summary: Functioned as a Consultant Medical Director for Transcranial Magnetic Stimulation (TMS) medical device franchise. Assisted COO and CEO on business related to Regulatory and Medical Affairs, Clinical research, Product commercialization and development, Medical information management and Grants Support. Interacted with payers and key opinion leaders (KOLs) to identify opportunities with strong clinical indications, present clinical evidence and lectures.
Main Activities:
- KOL Management & Medical Support
- Scientific Research Support
- Scientific Exchange/Insights
- Scientific Projects
- Medical review of core promotional material
- Internal Nvation Support
Accomplishments:
- Developed medical tactics strategic budgets, medical tactical plans, and product promotion plans for Nvation dTMS franchise.
- Provided Medical leadership and expertise in the development of product monographs and other promotion material.
- Functioned as an integral member of the brand team and provided technical input in the development of brand plans, promotional strategy, CME platform, and scientific operations.
- Raised strong partnerships with Clinical & Scientific Leaders, investigators and health care professionals as a scientific partner for research and therapy.
- Conceived, planned and initiated strategic Webinars influencing earlier use of TMS therapy in MDD and other NeuroPsychiatric disorders.
- Successfully conducted scientific sessions and represented Nvation at the National Clinical TMS Society & ISEN meetings 2013, and actively promoted Nvation at the 2013 APA meeting.
- Lead a Web-based Clinical Ad-board in 2013. From February 2014 to December 2014 (11 months) Clinical Research Physician Scientist @ Summary: Functioning as a Consultant Medical Advisor & Clinical Research Scientist and collaborating in different clinical research projects focusing on Neuromuscular disorders .
Research Project: Incentives to reveal Impulse Control Disorders due to Dopamine Agonists. From February 2013 to February 2014 (1 year 1 month) Medical Advisor & Doctoral Clinical Research Physician Scientist @ Summary: Functioning as a clinical researcher leader, scientific consultant, and educator. Responsible for hypothesis formulation, research, data analysis and interpretation on multiple projects. Communicated results at national/international meetings. Published high impact papers helping bring in research funding. Collaborated extensively with fellow researchers. Closely trained and supervised research projects of BSc, MSc and MD students.
Project 1: Catechol-o-methyltransferase (COMT) Val108/158 Met polymorphism and ADHD: Pharmaco-Behavioural genetic and Neurocognitive study.
Project 2: Genetic Risk And Neuro-Imaging in children with ADHD.
Project 3: Multiple Stratergies to unravel the complex genetics of ADHD.
Accomplishments:
- 2013: AAAS (American Association for the Advancement of Science)/Science Program for Excellence in Science.
- 2013: Research Excellence Award, HGen, McGill University.
- 2013: HGen McGill Top Doctoral Candidate Scientific Travel Award - presented research at 3rd Canadian Obesity Summit 2013.
- 2013: HGen McGill Doctoral Training and Travel Award - 2nd Canadian Human and Statistical Genetics Meeting 2012, Esterel Quebec.
- 2012: Nominated by McGill amongst top 5% doctoral student selected to present research at Canadian Student Health Research Forum 2012 Mannitoba and recieved Graduate Research Travel Fellowship.
- 2012: Graduate Research Training and Travel Award - 1st Canadian Human and Statistical Genetics Meeting 2012, Niagara Falls Ontario, Department of Human Genetics, McGill University.
- Best Poster presentation award, Molecular Biology Category. 10th Annual McGill Bio-medical Graduate Conference, Feb 2010.
- McGill Behaviour, Genes and Environment Graduate Training Fellowship 2006 – 2010, CIHR Program for the Study of Behavior, Genes and Environment.
- “Rising Researcher” by the CCHCSP, and invited to present at the Annual CCHCSP symposium 2007.
- Graduate Training Stipend 2005 – 2007, funded by FRSQ research grant. From May 2004 to February 2014 (9 years 10 months) Physician Medical Advisor - CNS Franchise @ Summary: Functioned as a Consultant Therapeutic area expert for CNS franchise.
Main Responsibilities:
Product Commercialization and Development:
-Serving as member of development and brand teams for Otsuka products.
-Providing medical input to all aspects of product development beginning in Phase III and providing medical input to promotion at launch through the entire product lifecycle.
-Working with marketing and legal departments to review promotional and other product materials in accordance with DDMAC regulations.
-Supporting in reviewing clinical results and developing appropriate communication vehicles (i.e., publications, posters, presentations, PR, etc.).
-Supporting in the execution of medical affairs plan for Otsuka products.
-Reviewing safety information generated by Pharmacovigilance, takes part in discussions regarding interpretation of safety findings, and assists with periodic and other safety reports.
-Identifing, developing, and maintaining relationships with external consultants, KOLs, investigators and vendors.
-Participating in extramural conferences and scientific meetings to maintain awareness of research in the field.
-Supporting in applying strategic intent of OCPI when working with FDA, healthcare providers and consumers of OCPI products.
-Managing and executing Phase 4 studies.
-Managing and executing publication plan.
-Managing Investigator Sponsored Trials.
In-house Customer Support:
-Providing training support to sales staff as needed.
-Keeping abreast of current state-of-the-art developments relating to in-house medical program focus, and providing education to clinical staff and other project team members.
-Serving as a source of medical expertise on Otsuka clinical trials for in-house customers.
Medical Information and Grants Support:
-Providing direction for medical information team.
-Reviewing grant requests as needed. From October 2012 to January 2013 (4 months) Montreal, Canada AreaMedical Scientific Advisor & Research Physician @ From January 2005 to December 2011 (7 years) Clinical Research Polysomnographer @ Summary: Worked as a Medical Polysomnographer and helped in collecting data for different clinical research projects.
Acknowledged for valuable clinical and research support in Research Projects/Publications;
1. PhD thesis titled: Dopamine and Light: Dissecting the Effects on Mood and Motivational States in Mildly Seasonal Women.
2. Research Manuscript titled: Dopamine and light: dissecting effects on mood and motivational states in women with subsyndromal seasonal affective disorder. Cawley EI, Park S, Aan Het Rot M, Sancton K, Benkelfat C, Young SN, Boivin DB, Leyton M. J Psychiatry Neurosci. 2013 Jun 4;38(3):120181. doi: 10.1503/jpn.120181. [Epub ahead of print].
3. Research Manuscript titled: Nocturnal polysomnographic sleep across the menstrual cycle in premenstrual dysphoric disorder. Ari Shechter, Paul Lespérance, N.M.K. Ng Ying Kin, Diane B. Boivin. Sleep Medicine 13 (2012) 1071–1078.
4. Research Manuscript titled: A Circadian Rhythm in Heart Rate Variability Contributes to the Increased Cardiac Sympathovagal Response to Awakening in the Morning. Philippe Boudreau, Wei Hsien Yeh, Guy A. Dumont, and Diane B. Boivin. Chronobiology International, 29(6): 757–768, (2012). DOI: 10.3109/07420528.2012.674592.
5. Research Manuscript titled: Phototherapy and Orange-Tinted Goggles for Night-Shift Adaptation
of Police Officers on Patrol. Diane B. Boivin, Philippe Boudreau, and Geneviève M. Tremblay. Chronobiology International, 29(5): 629–640, (2012). DOI: 10.3109/07420528.2012.675252. From June 2009 to June 2011 (2 years 1 month) Behavioural Sleep Medicine & Clinical Polysomnography @ Summary: Worked as a Clinical Polysomnography Consultant by following established sleep laboratory SOPs, and BRPT professional practice standards of conduct. From June 2008 to December 2008 (7 months) Medical Affairs, Clinical Research & Pharmacovigilance Physician @ Summary: Worked as a Clinical Research & Pharmaco-vigilance Consultant, involved in adverse event monitoring and reporting & clinical trial monitoring and administration.
Project: AVANT-GARDE Study; Phase IV Study of ALTACE. From September 2004 to March 2005 (7 months) Medical Advisor & New Product Planning Manager - CVS, CNS & I.D Portfolio @ Summary: Worked closely with the Director Marketing on a variety of new product planning, marketing and market research activities across Pfizer’s portfolio of products including cardiovascular (CVS), genitor-urinary (GU), Infectious disease (ID), and Nervous system (NS). From January 2004 to April 2004 (4 months) Family Physician - Mental Health @ Summary: Worked as a Family physician focused on promoting health and preventing diseases, illnesses, and injuries. The first contact between patients and the healthcare system. Co-ordinating ongoing care and getting patients to participate more fully in their healthcare. From August 2001 to March 2004 (2 years 8 months) Medical Advisor & Product Physician - CVS, CNS & G.P Portfolio @ Summary: Assisted the Medical Director on Pfizer business related to Medical Affairs, clinical research and development, regulatory affairs. Provided medical input for the development of launch plans, plans of action (POAs), promotional pieces, and activities of pharmaceutical products in the CVS, CNS, & G.P bussiness units to promote sales growth. Worked closely with product managers and training managers to provide appropriate awareness on diseases and products to sales staff. And continually updated sales staff on scientific aspects of responsible products.
Responsibilities:
- Product Reference Point.
- Clinical Trial Identification, Design, Planning, Implementation, & Management.
- Clinical Trial Data Analysis and Publication of results.
- Pharmacovigilance.
- Strategic contribution to Brand Plans & Strategies.
- Contribution & Review of Brand Promotional Material.
- Strategic Input to product labeling process.
- Contribution to Customer Focused Activities.
- Expert Contribution to Marketing team & Scientific Training of Sales force.
- Development and delivery of presentations and publications.
Accomplishments:
- Successfully launched BPH awareness campaign for Cardura; resulting in product growth, making Cardura No.1 Urological product (IMS 3Q 2002).
- Received letter of appreciation from CEO for developing patient education Booklets for Benign Prostate Hyperplasia (BPH) & Premenstrual syndrome (PMS) 2002.
- Successfully launched BENYLIN-E Cough syrup, a unique formulation the first expectorant, cough sedative in Pakistan (IMS 2Q 2003).
- Best Marketing Plan Team Award, Pfizer Product Manager Training Program 2003. Pfizer PMTP training, Istanbul Turkey.
- Received Acknowledgement as "Best Trainer" in Pfizer-Pharmacia Integration training, June 2003. From January 2002 to December 2003 (2 years) Physician Medical Expert & Product Manager - CNS, CVS & Urology Portfolio @ Summary: Responsible for the planning and implementation of the marketing strategy, marketing programs, and promotion activities. Assisted in healthcare PR campaigns, events organization, KOLs development and ethical marketing projects. Accountable for the development of market share and sales income for the products for Cardiovascular (CVS) & Genitourinary (GU) Portfolio drugs.
Accomplishments:
- Received shield of honour and certificate of appreciation from MOH Pakistan and WHO for Conference Management; "7th Int. Workshop on Management, Production & Quality Assurance of Drugs, November 2001.
- Successfully launched CAD & ISH strategies for Norvasc; resulting in 11 % product growth, making Norvasc No.1 Cardiovascular product (IMS 2Q 2002).
- Re-positioned Accupril for Hypertension market; resulting in product growth of 8% (IMS 4Q 2001). From August 2001 to March 2002 (8 months) Resident Medical Officer - Family Practice Residency Training (MRCGP-INT. program) @ From December 1997 to July 2001 (3 years 8 months) MD Candidate - Physician Assistant - Clinical Research Coordinator @ Summary: Worked as a Physician Assistant and Clinical research Coordinator.
Physician Assistant responsibilities; organized and implemented disease management programs for patients. Obtained patient vitals and presenting complaints in concurrence with World Health Organization approved practices in preparation to see the physician. Obtained and documented patient history, medication use and chief complaints. Performed phlebotomy, physical exams, urinalysis, neurology exams, ECGs and other procedures relevant to patient diagnostic and treatment regime.
Research Coordinator responsibilities; Coordinated Phase II, III and IV pharmaceutical research trials in accordance with ICH/GCP guidelines. Recruited patients to participate in research studies. Explained study design, purpose and requirements to participants. Pre-screened subjects for study eligibility. Independently conducted patient visits. Dispensed/received study medication. Performed phlebotomy/lab procedures. Monitored adverse events and perform rating scales and clinical assessments. Completed all data entry required after each visit; including answering sponsor queries. Meticulously document all patient correspondence. Maintained excellent communication with study team, sponsor and IRB. Submitted all required documentation to study team, sponsor and IRB. Maintained patient and regulatory master files to assure audit readiness; including proper filing of documents. Maintained and organize department supplies; including lab kits, scales, binders and study medication. From July 1994 to November 1997 (3 years 5 months)
Doctoral Studies - PhD, Human Genetics (NeuroPsychiatry Genetics), CUM GPA: 3.85 @ McGill UniversityGraduate studies - MSc, Psychaitry @ McGill UniversityGraduate studies - Post Graduate Certificate, Sleep Medicine - Polysomnography @ Michener InstituteGraduate studies - MBA, Marketing (Health Care - Pharmaceutical) @ Al-Khair UniversityGraduate studies - MCS, Computer Science, Medical Informatics. @ SZABIST (Shaheed Zulfiqar Ali Bhutto Institute of Science & Technology)MD Postgraduate studies - Certificate, Continuing Health Professional Education, Family Medicine @ McGill UniversityMD Undergraduate studies - MBBS, Medicine @ Karachi University, Sind Medical CollegeCollege studies - Pre-Medical Sciences, Biology, Chemistry, Physics @ D.J Govt. Science College Zia MBA is skilled in: Clinical Trials, Clinical Research, Infectious Diseases, Pharmaceutical Industry, Medicine, Pharmacovigilance, Neurology, Regulatory Affairs, Healthcare, Oncology, Psychiatry, Medical Affairs, Clinical Development, Medical Devices, Medical Writing