Lynn HARLLEE BICHAJIAN, MD
Charlottesville,USA
Summary
Senior Medical Director, specializing in clinical drug development and medical affairs, with extensive experience in anesthesia and pain management. Proven track record in executing successful clinical trials and collaborating with key opinion leaders. Recognized for innovative contributions, including award-winning pharmacokinetic/pharmacodynamic (PKPD) modeling research and effective leadership of cross-functional teams
Overview
31
31
years of professional experience
4
4
Certifications
Work History
SENIOR MEDICAL DIRECTOR, CLINICAL DRUG DEVELOPMENT
Eagle Pharmaceuticals, Inc.
(Acquired Acacia Pharma, Inc. in June 2022)
06.2022 - 11.2025
- Acacia/Eagle trial physician for pediatric remimazolam clinical trial in procedural sedation (Clinicaltrials.gov identifier NCT04851717)
- Clinical trial physician/medical monitor for Acacia/Eagle pediatric amisulpride postoperative nausea and vomiting (PONV) prophylaxis clinical trial (Clinicaltrials.gov identifier NCT05546359)
- Collaborated with internal teams and CROs on trial execution, providing guidance on protocol-specific clinical issues, site challenges, safety monitoring, and recruitment strategies to ensure successful trial outcomes.
- Ensure planning, implementation, management, and reporting of clinical trials according to postmarketing FDA requirements
- Drafted, reviewed, and authorized clinical trial protocols, investigator brochures, and clinical study reports to support regulatory compliance and trial integrity.
- Guided R&D and regulatory teams on clinical and medical responses to regulatory inquiries, facilitating meeting preparations and briefing package reviews to ensure alignment with regulatory expectations.
- Worked with PKPD modeling experts at University Medical Center, Gröningen, Netherlands, to develop dosing guidance for pediatric remimazolam.
- Showcased UMCG/EaglePaion poster highlighting PKPD modeling findings, securing first prize at the International Society for Anaesthetic Pharmacology Annual Meeting on October 13, 2023, in San Francisco
- Published PKPD modeling work as a manuscript in Anesthesiology, the premier anesthesia journal, in 2025.
MEDICAL SCIENCE LIAISON
Acacia Pharma, Inc.
11.2018 - 06.2022
- Field-oriented position overseeing Mid-Atlantic region for a small start-up commercial-stage biopharmaceutical company
- Managed two branded acute care products, Barhemsys (amisulpride) and Byfavo (remimazolam), throughout pre- and post-launch stages.
- Collaborated closely with leadership counterparts, including Regional Business Director and Director of National Accounts, to secure formulary approval
- Launched Acacia's first Medical Affairs team
- Created standard response letters for medical information requests to streamline communication.
Participated in medical review committee to evaluate and enhance clinical processes.
Developed processes for handling medical information requests, improving efficiency.
Collaborated with multidisciplinary teams to ensure compliance with medical standards.
Reviewed and analyzed incoming medical information requests for accuracy.
Established protocols for timely responses to medical inquiries, ensuring clarity.
Maintained documentation of medical information requests and responses for auditing purposes.
Provided training on new procedures related to medical information management. - Educated commercial and medical colleagues on product knowledge to strengthen team capabilities and support effective communication.
- Engaged in scientific meetings with key opinion leaders (KOLs) to share product insights, stay updated on recent developments, and disseminate scientific data.
- support of clinical trials encompassing investigator-initiated studies, PONV registry trial, and postmarketing pediatric clinical trials.
- Clinical anesthesia expertise requested by leadership for guidance on acquiring new products (including Byfavo due to extensive anesthesia/sedation experience)
- Presented with the Excellence and Innovation Award-First Place at the Society for Ambulatory Anesthesia 34th Annual Meeting (2019), Austin, TX ("Amisulpride is Effective for Rescue of Ambulatory Patients with Postoperative Nausea and Vomiting: Data from a Randomized, Placebo-Controlled, Phase III Study")
SENIOR MEDICAL SCIENCE LIAISON
Mallinckrodt Pharmaceuticals
02.2016 - 10.2018
- Transitioned from clinical practice to a Medical Affairs role in the pharmaceutical sector
- Functioned as medical and scientific authority on branded product Ofirmev (IV acetaminophen).
- Facilitated effective utilization of Ofirmev as a key scientific resource for the team, improving understanding and application of the product.
- Cultivated and sustained peer relationships with key opinion leaders in pain, anesthesia, and acute care to enhance collaboration and knowledge exchange.
- Created comprehensive medical presentations for various advisory boards and focus groups.
Engaged audiences at conferences through informative presentations.
Led in-service sessions to disseminate critical information effectively. - Took on responsibility as one of three MSLs for three new hemostatic drugs launched in 2016-17 while continuing Ofirmev roles.
- Selected to participate in R&D discussions due to comprehensive clinical expertise
MEDICAL DIRECTOR
Transitions Home Health and Private Care Company
11.2015 - 02.2016
- Senior medical administrative position in private home health care agency
- Provided medical direction and guidance for nursing and treatment staff
- Led medical operations, ensuring alignment with agency goals and standards
- Monitored quality and appropriateness of medical care, implementing improvements based on findings.
- Facilitated communication between local medical staff and agency to enhance collaboration and care coordination
- Assisted in developing policies and procedures
CLINICAL ANESTHESIOLOGIST AND SHAREHOLDER
Anesthesia Associates of Massachusetts PC
09.2001 - 03.2015
- Anesthesia services provided for multiple surgical lines including general, ambulatory, vascular, thoracic, ENT, pediatric, obstetrical/gynecological, orthopedic (including ultrasound-guided nerve blocks), urologic, neurosurgical, ECT (psychiatric electroconvulsive shock) and acute pain services.
- Managed in-house and back-up anesthesia call as anesthesiologist-in-charge, coordinated operating room schedules, and collaborated with OR, PACU, and Labor & Delivery teams to ensure seamless patient care.
- Delivered continuous anesthesia services in private practice, ensuring high standards of patient safety and comfort throughout procedures.
- Credentialed at multiple hospitals/surgicenters including St Luke's Hospital in New Bedford, Hawthorne Ambulatory Surgical Center (freestanding, physician owned) in Dartmouth, Beth Israel-Deaconess Glover Hospital in Needham, and Mount Auburn Hospital in Cambridge.
CLINICAL INSTRUCTOR OF ANESTHESIA AT HARVARD MEDICAL SCHOOL AND STAFF ANESTHESIOLOGIST
Anesthesiologists of Mount Auburn
09.1994 - 09.2001
- Anesthesia services provided for multiple surgical lines including general, ambulatory, cardiac, vascular, thoracic, obstetrical/gynecological, ENT, orthopedic, urologic, neurosurgical, intensive care coverage, and both acute and chronic pain services.
- Coordinated in-house and back-up anesthesia call coverage, managed operating room schedule, collaborated with OR, PACU, and L&D charge nurses, managed emergency code coverage, and created anesthesia OR assignments for the anesthesia department.
- Achieved promotion to partner and shareholder at Anesthesiologist of Mount Auburn PC following anesthesia board certification (1997), gaining voting rights.
- Delivered 24/7 anesthesia coverage for private practice anesthesia group.
Education
Chief Resident of Anesthesia -
Brigham And Women's Hospital
Boston, MA08.1994
Clinical Fellow of Anesthesia -
Harvard Medical School, Brigham & Women's Hospital
Boston, MA08.1994
Internship in Internal Medicine -
University of Miami Miller School of Medicine
Miami, FL06.1991
M.D. -
University of Miami Miller School of Medicine
Miami, FL05.1990
Bachelor of Arts -
Cornell University College of Arts and Sciences
Ithaca, NY05.1984
Skills
- Drug development
- Medical Affairs
- Clinical trial physician
- Medical monitoring
- Anesthesia and pain clinical expertise
- Subject recruitment
- Clinical pharmacology
- Clinical trial compliance
- Risk management
- Ethics knowledge
- ICH GCP
Certification
- Board certification, American Board of Anesthesiology (granted into perpetuity)
- Advanced Physician Medical Monitoring Certification through Certified Clinical Research Professionals Society (CCRPS)
- Course certification in Drug Metabolism - Principles and Applications, Drug Product Development, University of Wisconsin-Madison School of Pharmacy
- Course certification in Pharmacokinetics and Pharmacodynamics, University of Wisconsin-Madison School of Pharmacy
Publications
- Pharmacokinetics and pharmacodynamics of remimazolam for procedural sedation in children and adolescents., Anesthesiology, 2025
- Randomized, double-blind, parallel-group active-controlled Phase 2/3 study of intravenous amisulpride as prevention of postoperative nausea and vomiting: Trial in progress., Society for Ambulatory Anesthesia (SAMBA) annual meeting, Savannah, Georgia, 05/03/2024
- Documented sustained response of intravenous amisulpride for rescue treatment of postoperative nausea and vomiting: Results from a Phase III trial., American Society of PeriAnesthesia Nurses (ASPAN), Orlando, Florida, 04/16/2024
- Amisulpride provides significant nausea reduction in patients with established postoperative nausea and vomiting: Pooled results from two phase III trials., Postgraduate Assembly in Anesthesiology (PGA) annual meeting, New York, 12/11/2023
- Pharmacokinetics and pharmacodynamics of remimazolam for procedural sedation in children and adolescents., International Society for Anaesthetic Pharmacology (ISAP) annual meeting, San Francisco, 10/13/2023
- Comparing relative effects on cognitive function following sedation with remimazolam vs midazolam as measured by the Hopkins Verbal Learning Test., Society for Neuroscience in Anesthesiology and Critical Care (SNACC) annual meeting, Alexandria, Virginia, 09/09/2023
- Safety profile of the benzodiazepine remimazolam for procedural sedation in higher risk patients (ASA III/IV): Results from a randomized clinical trial., Society for Ambulatory Anesthesia (SAMBA) annual meeting, Phoenix, Arizona, 05/13/2022
- Sedation with intravenous remimazolam provides rapid onset, recovery and discharge readiness in bronchoscopy patients: results from a randomized clinical trial., CHEST virtual annual meeting, 10/17/2021
- Intravenous amisulpride provides rapid and durable treatment of established postoperative nausea and vomiting., SAMBA virtual annual meeting, 05/13/2021
- Pharmacokinetics of selective D2/D3 antagonist IV amisulpride for postoperative nausea and vomiting: Elucidating effects in key neural circuits., American Society of Health-System Pharmacists (ASHP) virtual annual meeting, 12/08/2020
- Transient Pharmacophysiologic Effects of Intravenous Amisulpride on Serum Prolactin During Management of Postoperative Nausea and Vomiting (PONV)., Society for Ambulatory Anesthesia (SAMBA) virtual annual meeting, 06/06/2020
- Intravenous amisulpride does not meaningfully prolong QT at doses effective in postoperative nausea and vomiting., ASA annual meeting, 10/22/2019
- Amisulpride is Effective for Rescue of Ambulatory Patients with Postoperative Nausea and Vomiting: Data from a Randomized, Placebo-Controlled, Phase III Study., ASA annual meeting, 10/19/2019
- Amisulpride is Effective for Rescue of Ambulatory Patients with Postoperative Nausea and Vomiting: Data from a Randomized, Placebo-Controlled, Phase III Study., SAMBA annual meeting, 05/11/2019
- Amisulpride for the rescue treatment of postoperative nausea and vomiting in high-risk patients who failed prophylaxis: impact of risk factors and number of prophylactic agents on treatment success., Annual Congress of Enhanced Recovery and Perioperative Medicine, Washington, DC, 04/26/2019
- Treatment options for chronic lower back pain., Medical Grand Rounds, Mount Auburn Hospital, Cambridge, Massachusetts, 03/1996
- New Advances in Neuromuscular Blockade., Brigham and Women's Department of Anesthesia Grand Rounds, Boston, Massachusetts, 07/15/1992
- Evidence for paired M2 muscarinic receptors., Molecular Pharmacology, 1991
- Behavioral Assessment of Alcohol Dependence., Assessment of Addictive Behaviors: Behavioral, Cognitive, and Physiological Procedures, 1988
- Individual differences in the reliability of alcoholics' reports of drinking., Annual meeting of the American Psychological Association, Washington, DC, 1986
- Reliability of reports of temporal patterning of drinking behavior by alcoholics., Annual meeting for the Advancement of Behavior Therapy, Houston, Texas, 1985
Languages
- Spanish
- German, Elementary
- Spanish, Limited Working
Timeline
SENIOR MEDICAL DIRECTOR, CLINICAL DRUG DEVELOPMENT
Eagle Pharmaceuticals, Inc.
06.2022 - 11.2025
MEDICAL SCIENCE LIAISON
Acacia Pharma, Inc.
11.2018 - 06.2022
SENIOR MEDICAL SCIENCE LIAISON
Mallinckrodt Pharmaceuticals
02.2016 - 10.2018
MEDICAL DIRECTOR
Transitions Home Health and Private Care Company
11.2015 - 02.2016
CLINICAL ANESTHESIOLOGIST AND SHAREHOLDER
Anesthesia Associates of Massachusetts PC
09.2001 - 03.2015
CLINICAL INSTRUCTOR OF ANESTHESIA AT HARVARD MEDICAL SCHOOL AND STAFF ANESTHESIOLOGIST
Anesthesiologists of Mount Auburn
09.1994 - 09.2001
Chief Resident of Anesthesia -
Brigham And Women's Hospital
Clinical Fellow of Anesthesia -
Harvard Medical School, Brigham & Women's Hospital
Internship in Internal Medicine -
University of Miami Miller School of Medicine
M.D. -
University of Miami Miller School of Medicine
Bachelor of Arts -
Cornell University College of Arts and Sciences