Board-Certified Anesthesiologist · Principal Investigator
Dr. McCoun launches clinical research programs within established site infrastructure, builds and trains the teams that execute them, and serves as the protocol authority ensuring every trial runs to standard. Named PI on 30+ trials across 16 sponsors — 709 encounters and 620 completed cases in acute surgical pain alone over 39 months. First enrolled patient: ten weeks from hire date.
Background
Dr. McCoun is a board-certified anesthesiologist, Principal Investigator, and clinical research program builder specializing in non-opioid surgical pain. She architects programs, develops and trains the teams that execute them, and serves as the protocol authority responsible for trial integrity, patient safety, and sponsor-facing clinical oversight. She was among the first investigators named PI on the pivotal suzetrigine (JOURNAVX) Phase 3 trials, contributing to the first new class of non-opioid pain medication to receive FDA approval in over 20 years (January 2025).
From September 2022 through February 2026, she launched and led a new acute surgical pain clinical indication at CenExel ACMR (now CenExel Atlanta) — an established multi-specialty research site. Working within existing institutional infrastructure, she built the indication-specific team, established all surgical pain clinical workflows, and served as PI across every active trial. First enrolled patient was November 14, 2022 — ten weeks from hire date. The program produced 709 research encounters and 620 completed cases across 15 acute surgical pain trials over 39 months (November 2022 – February 2026). These figures represent the acute surgical pain portfolio only — her full PI portfolio spans 30+ trials across 16 sponsors and more than ten indications.
Prior to clinical research, Dr. McCoun was an attending anesthesiologist at Northside Hospital Atlanta (2012–2022), with expertise in epidural placement, peripheral nerve blocks, and CRNA supervision. She is an active member of the American Society of Anesthesiologists, American Society of Regional Anesthesia and Pain Medicine, Georgia Society of Anesthesiologists, and the International Association for the Study of Pain.
Her PI portfolio spans acute post-surgical pain, chronic pain (DPN, radiculopathy, CINP, CLBP), obstructive sleep apnea, GLP-1 and metabolic, vaccine, anesthesia, tobacco harm reduction, and opioid use disorder — across Phase 1 through Phase 3.
What We Do
Named PI for Phase 1–3 sponsored clinical trials in surgical pain, anesthesia, metabolic, vaccine, and adjacent indications. Serves as the protocol authority — ensuring trial execution meets sponsor, GCP, and regulatory standards from SIV through database lock. Active sponsor relationships across 16 organizations.
Chief Medical Officer advisory for clinical-stage pharma companies. Program strategy, Phase 2-to-Phase 3 transition planning, MSL function development, KOL engagement, and publication planning. Deep NaV1.8 and non-opioid pain expertise.
End-to-end program development for hospital-embedded and independent research sites — from infrastructure design and team recruitment to clinical workflow establishment and first patient enrollment. Dr. McCoun builds programs and the teams that run them, with protocol mastery as the foundation.
Independent medical monitor services for ongoing sponsored trials. AE and SAE review, safety narrative development, and medical officer functions. Available on retainer or per-trial basis.
Board-certified anesthesiologist available for research trial case coverage and protocol-specific anesthesia planning. Regional anesthesia expertise: epidural placement, peripheral nerve blocks, and CRNA supervision.
GCP training, protocol-specific team onboarding, blinded patient interaction standards, rater certification, and PI development for physicians entering clinical research leadership. A well-trained team executing a protocol correctly is the difference between a clean database and a warning letter.
Expertise
NaV1.8 inhibitor program including suzetrigine (JOURNAVX, FDA approved January 2025). PI across three pivotal Phase 3 suzetrigine trials. Procedures: abdominoplasty, bunionectomy, herniorrhaphy, breast reduction, rhinoplasty, reconstructive surgery.
Primary SpecialtyTotal knee arthroplasty, podiatric surgery, and musculoskeletal pain. Active Sub-Investigator relationships with high-volume orthopedic surgeons. Protocol experience across TKA indication types and post-surgical pain endpoints.
ActiveDiabetic peripheral neuropathy (DPN), lumbosacral radiculopathy, chronic low back pain, and chemotherapy-induced neuropathic pain (CINP). Phase 2 and Phase 3 experience across multiple compounds and sponsors.
ActiveNovel IV and inhalation anesthetic compounds in surgical settings. Phase 3 experience in reconstructive plastic surgery indications. Board-certified anesthesiologist with active clinical expertise in perioperative protocol design and execution.
ActiveObesity and metabolic surgical trial experience. Established relationships with GLP-1 sponsors. Northside Hospital Atlanta bariatric surgical volume provides direct patient access for this indication category.
AvailableVaccine (Phase 2/3), nicotine pharmacokinetics (Phase 1), human abuse liability (in-clinic confinement), and obstructive sleep apnea (Phase 3). Demonstrates breadth of regulatory and protocol expertise beyond surgical pain.
AvailableIn the News
As a named PI on the pivotal suzetrigine trials, Dr. McCoun has been interviewed across national and Georgia media on the FDA approval of JOURNAVX and its implications for surgical pain management.
TIME Magazine
FDA Approves the First Non-Opioid Pain Medicine in 20 Years
January 30, 2025 →
Boston Globe
FDA approves Journavx, new non-opioid painkiller from Vertex
January 30, 2025 →
Georgia Public Broadcasting
New non-opioid painkiller may help stop addiction before it starts
May 2025 →
Also Featured In
Georgia Today Podcast
11Alive / NBC Atlanta
ASRA Pain Medicine News
Peer-Reviewed Work
McCoun J, Winkle P, Solanki D, Urban J, Bertoch T, et al. Journal of Pain Research 2025;18:1569–76. DOI: 10.2147/JPR.S509144. PMID: 40165940.
First AuthorBertoch T, D'Aunno D, McCoun J, Solanki D, et al. Anesthesiology 2025;142:1085–99. DOI: 10.1097/ALN.0000000000005460. PMID: 40117446. Published March 21, 2025.
Co-Author · Named InvestigatorNaV1.8 pipeline — surgical pain indications. Details available upon request.
TIME Magazine · CBS News · Boston Globe · CNN (on-camera, Fredericka Whitfield) · Georgia Public Broadcasting · 11Alive / NBC Atlanta
Ready to Work Together
Sponsor feasibility evaluations, program build partnerships, medical affairs advisory roles, and speaking engagements are welcome. Dr. McCoun builds programs, trains teams, and serves as the protocol authority that makes trials execute correctly.
Initiate a Strategic Conversation
McCoun Clinical provides PI services, research program development, team training, CMO and medical affairs advisory, and independent medical monitoring. Dr. McCoun builds programs, develops the teams that run them, and maintains protocol authority throughout. Inquiries regarding sponsor feasibility, program partnerships, medical affairs roles, and speaking engagements are welcome.