CMO/ VP Clinical Development
Gary W. Jay, MD, FAAPM
16 Sydenham Rd firstname.lastname@example.org
Durham, NC 27713 C 203.745.7071
Chief Medical Officer/ Vice President
Executive with 9+ years of success in various pharmaceutical-industry environments. Set strategies that foster substantial growth, product development, and industry relations with comprehensive experience in the analgesic and CNS fields as well as significant credibility in these fields; influential with political savvy, demonstrates sound judgment, established work ethic, experientially enhanced decision-making capabilities, polished people skills, with a constant commitment to organizational goals and a wide range of contacts in the field. Leverage extensive private practice background; established first private interdisciplinary pain center in western US. One of 30 founders of American Academy of Pain Medicine, leading to development of Pain Medicine clinical subspecialty. Highly accomplished author and public speaker; responsible for 5 textbooks and numerous peer-reviewed articles. Have contributed to 3 NDAs and 4 INDs.
RAPID Pharmaceuticals, Rockville, MD- biotech with 6 working employees (September 2013 to present)
Chief Medical Officer, responsible for establishing clinical aspects of laboratory with no history of clinical expertise
- Responsible for determining the company’s strategic primary and secondary disease focus
- Currently working on two INDs
- The clinical head of the company helping them to bring their R&D Molecules into clinical space, working with a number of different clinical silos with molecular analogues
- Working with CSO on preclinical models
- Responsible for working with Regulatory consultant to develop needed documents (INDs)
- Working to develop a clinical section as the appropriate and necessary adjunct to the R&D Laboratory in Rockville, MD
Senior CNS Strategist / Senior Medical Director at INC, Medical Affairs: Provide key support, guidance, and leadership to this CRO- October, 2012 to September 2013
Consultant to Industry, multiple CROs, Biotechs and INC Research, Raleigh, NC May, 2011 – October, 2012
Levare Pharma- Chief Medical Officer- Left Archimedes to obtain funding for this new analgesic pharmaceutical company
Archimedes Pharma, Bedminster, NJ 2010 – 2011
[Pharmaceutical company with up to 200 employees.]
Chief Medical Officer / Senior Vice President: Establish domestic clinical programs and department, and review and update UK-based clinical program. Develop US and UK drug safety and pharmacovigilance groups. Coordinate MIS group for global company. Work with US NDA.
- Provided strategic vision, leadership and management, as the only (opioid trained) pain specialist in the company whose only drug (in the US) was an intranasal analgesic
- Assembled US/UK Medical Affairs groups, including MSL team
- Assembled US and UK Safety and Pharmacovigilance teams
- Recruited the best people to populate the Medical Affairs, PV/Safety roles, MSL group and Clinical Development group in both the US and the UK
- Wrote REMS program for rapid-onset opioid; worked with regulatory group to finalize with FDA
- Developed and organized key studies for label enhancement, and worked with CROs to establish trials.
- Created and implemented 3 EU phase-4 trials.
- Developed successful pediatric clinical development program.
- Developed Pediatric Clinical Development Program.
- Worked with Marketing and Commercial on product launch.
- Worked with US NDA (EU already approved)
Pfizer, INC, New London, CT 2007 – 2010
[Pharmaceutical company with 120K employees worldwide.]
Clinical Disease Area Expert – Pain (2008 – 2010) / Senior Medical Director (2007 – 2008): Quickly promoted as member of 6-person Primary Care Business Unit Leadership Team. Drove international pain disease area portfolio and strategy. Reviewed and approved drugs for inclusion with portfolio after successful POC (2a) trial. Managed pain-related information and analgesic trial design. Chair of technical review committee (TRC) for all protocols in primary care unit, 2b-4. Ensured compliance with enhanced quantitative drug development (EQDD) and enhanced trial design (ECTD) processes. Taught pain trial methodology to primary care unit. Determined which drugs would enter pain portfolio.
Co-chaired Disease Area Strategy Team and Pain Clinical Trial Methodology Group. Member of patient benefit/risk teams for Tanezemab, Lyrica, and Celebrex; neuropsychiatry and abuse potential advisory council; and business development leadership team (SORT).
- Was able to use strategic vision, using cross-functional (matrix) oriented leadership and operational skills
- Achieved 100% of all objectives, coordinating key business development and operational integrity.
- Established Pain Technical Review Committee as premier TRC in primary care group.
- Played central leadership role in development of Tanezemab.
- Facilitated growth by conducting due diligence to help attain appropriate drug lines.
- Worked hand-in hand with commercial group on in-line drugs such as Lyrica for fibromyalgia as well as new drugs
- Worked closely with regulatory to establish FDA parameters on both new and in-line drugs to enlarge/establish labels and deal with regulatory issues
- Represented company at PACE group addressing federal government’s CER (Comparative Effectiveness Research) trials.
- Forged productive relations with Arthritis Foundation, American Chronic Pain Association, and Reflex Sympathetic Dystrophy Syndrome Association.
- Published 3 medical textbooks and 3 peer-reviewed journal articles on pain and headache.
- Lectured at 10 national medical venues.
UCB / Schwarz, Raleigh, N C 2005 – 2007
[Pharmaceutical company with ~4K employees pre purchase by UCB.]
Medical Director: Coordinated medical/clinical and safety aspects of anticonvulsant studies for pain indication. Developed lifecycle management for 2 medications. Provided medical oversight of numerous clinical trials. Granted medical/clinical insight to due diligence activities in conjunction with company’s business development group. Answered post-NDA questions for FDA and MAA questions for EMEA submissions for epilepsy and diabetic neuropathic pain, as well as FDA questions post submission.
- Member of anticonvulsant submission team that completed and filed NDAs on time for both pain and epilepsy.
- Developed new corporate strategy and templates for writing narratives.
- Established validatable psychological test for impulse control disorders for use with company’s dopamine agonist: Jay Modified Minnesota Impulse Control Interview (MIDI), approved by Agency.
- Medical co-author of cardiovascular safety document, including data analysis and narratives that supported Anticonvulsant Medication NDAs.
- Worked closely with Regulatory group with FDA to establish plans and deal with issues on new drugs, as well as pre-NDA
- Developed 3 lifecycle protocols, obtained CROs, and started trials.
- Built reputation as clinical troubleshooter dealing with FDA concerns for multiple Schwarz studies across several compounds and indications.
A neurologist with twenty-five years of experience in private practice for headache, migraine, post-operative pain, chronic non-cancer pain of all types (including victims of torture from around the world) and cancer related pain including BTCP, and several general CNS indications (including spasticity, Parkinson’s disease, sleep disorders, and musculoskeletal pain). Also specialized in the diagnosis and treatment of Mild Traumatic Brain injury and Complex Regional Pain Syndrome.
- Started first private interdisciplinary pain center west of Mississippi.
- Broad experience developing study protocols for various chemical entities across multiple indications and trial phases as well as interpreting clinical data for a number of pharmaceutical companies..
- Performed pharmaceutical research for Glaxo (sumatriptan), Elan Pharmaceuticals (MyoBloc), Allergan (Botox), McNeil Pharmaceuticals (Zomepirac with codeine and Zomepirac) and Sandoz (Biarsan Sodium and codeine).
- Chaired multidisciplinary groups and wrote diagnostic and treatment algorithms for Colorado Department of Labor including complex regional pain syndrome, chronic non-cancer pain, and minor traumatic brain injury, passed into law.
Residency: Department of Neurology, Northwestern University Medical Center, Chicago, IL
Internship: Department of Internal Medicine, Northwestern Memorial Hospital, Chicago, IL
MD, Northwestern University, Chicago, IL
BA, Franklin & Marshall College, Lancaster, PA
President, Eastern Pain Association (first offshoot of APS/IASP)
One of 30 founders of American Academy of Pain Medicine (ne: Algology),
leading to development of clinical subspecialty of Pain Medicine.
One of 8 founders of American Academy of Pain Management. Past President.
Past Member, Board of Directors, American Association for the Study of Headache
Past President, Florida Academy of Pain Medicine
Founder / First President, Southern California Pain Society
Publications & Presentations
Author of 120+ medical textbook chapters; peer-reviewed journal articles; and 5 textbooks including “Chronic Pain,” “Practical Guide to Chronic Pain Syndromes,” “Clinicians Guide to Chronic Headache and Facial Pain,” “Minor Traumatic Brain injury Handbook, and “Headache Handbook.”
Delivered lectures (over 400) nationwide and over-seas, on headache, Pain Medicine disorders, and minor traumatic brain injury as well as pain chronicity and others.
Janet Travel Clinical Pain Management Award, American Academy of Pain Management, 2006
John Liebeskind Research & Education Award, American Academy of Pain Management, 2009