CAROLYN McMICKEN
Clinical Science / Medical Affairs
North Wales,PA
Summary
Senior Director of clinical development with over 20 years of experience in research, medical affairs and clinical development, specializing in CNS programs including neurology, psychiatry, and rare diseases. Demonstrated ability to lead cross-functional teams to achieve successful project outcomes. Skilled in developing clinical and medical strategies that prioritize patient-focused drug development for small molecules and gene therapies. Recognized for effective collaboration with stakeholders while ensuring compliance with GCP, ICH, and FDA/EMA regulations.
Overview
21
21
years of professional experience
Work History
Senior Director, Clinical Development - Neurology & Gene Therapy
Neurocrine Biosciences, Inc.
San Diego (Remote)
02.2025 - Current
- Lead the global clinical development strategy and execution for a gene therapy candidate targeting a CNS disorder.
- Oversee Phase I-III programs in neurological and psychiatric indications, ensuring scientific integrity and GCP compliance.
- Provide leadership for protocol design, SAPs, investigator brochures, and study reports in alignment with FDA/EMA expectations.
- Collaborate cross-functionally with Regulatory Affairs, Clinical Operations, and Medical Affairs to drive integrated development planning.
- Champion organizational transformation through process improvement, change management, and patient engagement initiatives.
Director, Clinical Development - Neurology & Rare Disease
Neurocrine Biosciences, Inc.
San Diego (Remote)
02.2021 - 02.2025
- Directed clinical strategy for multiple CNS and rare disease programs, including SCN8A-DEE, EE-CSWS, DCP, and focal onset seizures.
- Led clinical outcome assessment development and endpoint validation for epileptic encephalopathies.
- Served as Patient-Focused Drug Development (PFDD) Lead, incorporating the patient voice into clinical design and interpretation.
- Partnered with HEOR and Medical Affairs to generate evidence supporting payer engagement and regulatory value demonstration.
- Contributed to regulatory interactions and briefing documents supporting IND maintenance, and NDA preparation.
Director, Medical Science Liaisons - East
Neurocrine Biosciences, Inc.
San Diego (Field-based)
11.2018 - 01.2021
- Built and managed a team of eight senior MSLs, covering half the U.S. in support of commercial and pipeline CNS programs.
- Implemented the X-Fly insight capture and analytics system, improving the national data-driven medical strategy.
- Partnered with cross-functional leaders to design field medical strategy, speaker programs, and advisory boards for key product launches.
- Fostered relationships with key stakeholders to promote collaboration and support initiatives.
Sr. Medical Science Liaison, Mid-Atlantic
Neurocrine Biosciences
San Diego (Field-based)
02.2016 - 11.2018
- Hired in the first wave of the MSL team supporting late-phase clinical development and product launch for Neurocrine’s VMAT2 inhibitor (valbenazine) in tardive dyskinesia and Tourette’s disorder.
- Supported Ingrezza Speaker’s Bureau (approximately 20 speakers in region)
MSL lead for CRM customization and UAT - Provided guidance and input for the investigator-initiated study submission and internal review process.
- Connected KOLs with internal colleagues for a variety of collaborative projects and consulting opportunities.
- Involved in the planning and execution of Advisory Board meetings, including content, faculty/advisor identification, and presentation of scientific information.
- Collaborated with two MSL colleagues and the MSL director on defining MSL team goals for 2016, 2017, and 2018.
Senior Neurology Medical Science Liaison
Lundbeck U.S. Medical Affairs
Deerfield (Field-based)
05.2012 - 02.2016
- MSL Product Lead for Vigabatrin, collaborating with Clinical Development, Regulatory, and Biostatistics on medical publications, REMS, and post-market research.
- Supported global Alzheimer's and epilepsy Phase III programs, integrating field intelligence into trial planning and recruitment.
- Authored internal training resources and led MSL education programs, ensuring scientific and regulatory consistency.
CNS Medical Science Liaison
Lundbeck U.S. Medical Affairs
Deerfield (Field-based)
08.2010 - 05.2012
- Supported CNS portfolio, including tetrabenazine, vigabatrin, and clobazam, assisting CROs and investigators with clinical trial execution.
- Provided REMS education for vigabatrin, and developed regional KOL networks to support Phase III recruitment efforts.
Neuroscience Medical Science Liaison (MSL)
Merck (fka Schering-Plough Corporation)
Kenilworth (Field-based)
08.2009 - 07.2010
- Provided clinical and scientific support for the new product launch (Asenapine).
- Delivered clinical presentations for U.S. Managed Markets.
- Responded to unsolicited requests for on- and off-label scientific information.
- Developed relationships with key opinion leaders in therapeutic areas of interest.
- Supported training initiatives, including sales, speakers' bureau, U.S. managed markets, and Merck Health Science Associates (HSA).
- Monitored medical congresses for disease state information, new data, and competitive intelligence.
Clinical Science Manager (Neuroscience & Pain Care)
Abbott Laboratories, Global Pharmaceutical R&D
Abbott Park (Field-based)
08.2006 - 07.2009
- Managed field clinical engagement for epilepsy, mood, and pain programs, supporting investigator-initiated trials, and post-market research.
- Collaborated with Medical, Clinical Operations, and Marketing teams to translate new data into scientific education and training materials.
- Ensured study compliance with FDA regulations, ICH guidelines, and company SOPs.
Education
Bachelor of Science (B.S.) - Sport Management
Barry University
Miami ShoresDoctor of Psychology (Psy.D.) - Clinical Psychology - Neuropsychology Concentration
Carlos Albizu University
Miami, FLMaster of Science (M.S.) - Psychology
Carlos Albizu University
Miami, FLSkills
- Clinical development strategy
- CNS and rare disease expertise
- Phase I–IV trial execution
- Clinical outcome assessment strategy
- Relationship management
- Team leadership
- GCP and ICH compliance
- Cross-functional collaboration
- Patient-focused drug development
- Data analysis
- Process improvement and change management
- Partnerships and alliances
Affiliations
- American Epilepsy Society (AES)
- Inchstone Project Industry Advisory Panel
License
Licensed Psychologist, Pennsylvania, PS016116, Active
Selected Publications Presentations
- Unmet needs in epileptic encephalopathy with spike-and-wave activation in sleep., Chapman KE, Haubenberger D, Jen E, Tishchenko A, Nguyen T, McMicken C, et al., Epilepsy Res., 2024
- Efficacy of antiepileptic drugs in refractory partial-onset seizures., Slater J, Chung S, Huynh L, Duh MS, Gorin B, McMicken C, et al., Epilepsy Research, 2018
- Demographic and Clinical Characteristics of Pediatric Patients with SCN8A-related Epilepsies., McMicken C, et al., AES Annual Meeting, 2022
Timeline
Senior Director, Clinical Development - Neurology & Gene Therapy
Neurocrine Biosciences, Inc.
02.2025 - Current
Director, Clinical Development - Neurology & Rare Disease
Neurocrine Biosciences, Inc.
02.2021 - 02.2025
Director, Medical Science Liaisons - East
Neurocrine Biosciences, Inc.
11.2018 - 01.2021
Sr. Medical Science Liaison, Mid-Atlantic
Neurocrine Biosciences
02.2016 - 11.2018
Senior Neurology Medical Science Liaison
Lundbeck U.S. Medical Affairs
05.2012 - 02.2016
CNS Medical Science Liaison
Lundbeck U.S. Medical Affairs
08.2010 - 05.2012
Neuroscience Medical Science Liaison (MSL)
Merck (fka Schering-Plough Corporation)
08.2009 - 07.2010
Clinical Science Manager (Neuroscience & Pain Care)
Abbott Laboratories, Global Pharmaceutical R&D
08.2006 - 07.2009
Bachelor of Science (B.S.) - Sport Management
Barry University
Doctor of Psychology (Psy.D.) - Clinical Psychology - Neuropsychology Concentration
Carlos Albizu University
Master of Science (M.S.) - Psychology
Carlos Albizu University