Experience

LEO Pharma UK/IE

• United Kingdom
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Country Medical Director - UK & Ireland

  • Dec 2021 - Present

  Member of the executive leadership team for a full-cycle pharmaceutical company operating in over 100 markets. - Undertook major organizational change management, steering the Medical Division (UK & Ireland) through restructuring of Medical Affairs, Pharmacovigilance, Medical Information, Quality, and Field Medical (Medical Science Liaisons). - Implemented medical excellence framework with new robust ways of working, as part of global medical affairs leadership. Therapeutic Experience: Dermatology, All Stages Show less



GSK

• United Kingdom
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Global Medical Lead, Global Specialty Care

  • Aug 2018 - Dec 2021

  Advanced from a contributor role in the US to a Global Medical Affairs Lead for Hepatology, including managing markets such as the UK, Germany, Brazil, and Japan, and serving as the launch lead in Japan.- Crafted strategic plans as a key member of the medicine development team and commercial working group, product risk management, and regional launch activities across four regions. Therapeutic Experience: Hepatology, cholestatic pruritus, primary biliary cholangitis (PBC), and chronic liver disease; Phase: Commit to Phase 3 and Peri-launch Show less

• Launch Lead, Medical Affairs, Immuno-Inflammation

  • Jan 2018 - Jul 2018

  Developed launch strategy and external expert plans in collaboration with local medical, commercial, and development teams providing oversight and medical expertise and trained/mentored 7+ field medical staff. Served as the global medical expert to drive external engagement locally at launch.Therapeutic experience: Systemic Lupus Erythematosus (SLE); Phase: launch

• Senior Director, Global Medical Affairs

  • Jul 2014 - Dec 2017

  Spearheaded the development of annual global medical strategic and tactical plans, effectively serving as the regional global medical launch lead for US, Japan, and Brazil regions, resulting in 3 successful product introductions.Therapeutic experience: Systemic Lupus Erythematosus (SLE); Phase: launch and post-launch

• Scientific Director, US Medical Affairs

  • Mar 2012 - Jul 2014

  Facilitated strategic initiatives, including the development of US Medical Affairs Planning and launch planning- Designed and authored Clinical Protocol/Clinical Study Reports in collaboration with matrix team colleagues and external therapeutic experts, also serving as the author and clinical coordinator of sNDA summary documents.Therapeutic experience: Systemic lupus erythematosus (SLE); Phase: launch

• Clinical Development Manager & Clinical Investigator Lead

  • Sep 2004 - Apr 2012

  Clinical Lead for 10+ development studies on early phase and post-marketing commitment products providing clinical support for major depression in-licensing opportunity- Designed and authored Clinical Protocol/Clinical Study Reports in collaboration with matrix team colleagues and external therapeutic experts, also serving as the author and clinical coordinator of sNDA summary documents.- Drove strategic planning and preparation for FDA Advisory Committee Meetingslead clinical writer for schizophrenia pediatric development plan.Therapeutic experience: Attention deficit hyperactivity disorder (ADHD), major depressive disorder, pediatric depression, seasonal affective disorder, schizophrenia, migraine, myasthenia gravis, rare diseases Show less

• Lead Clinical Development Scientist

  • May 2002 - Sep 2004

  Offered critical scientific support for a development program focused on Seasonal Affective Disorder while authoring an influential concept protocol for Pediatric/Adolescent Major Depression. Demonstrated networking acumen by forging new relationships with external experts in pediatric depression.Therapeutic experience: Major depressive disorder, pediatric depression, seasonal affective disorder

• Clinical Research Associate

  • Jun 1999 - Jun 2001

  Key member of the clinical development team, acted as the liaison between sponsor and investigator. - Managed assigned investigational study sites and performed on-site quality reviews of case report form data and contributed to Clinical Study Report writing. Therapeutic experience: Bipolar disorder. Key member of the clinical development team, acted as the liaison between sponsor and investigator. - Managed assigned investigational study sites and performed on-site quality reviews of case report form data and contributed to Clinical Study Report writing. Therapeutic experience: Bipolar disorder.



Worldwide Clinical Trials

• United States
• Research Services
• 700 & Above Employee

• Clinical Research Associate

  • Jun 1998 - Jun 1999

  Managed assigned investigational study sites, acting as a liaison between sponsor and investigator and performing on-site quality reviews of case report form data. Conducted monitoring visits to ensure compliance with protocol, FDA and ICH regulations, Good Clinical Practices, and relevant standard operating procedures. Therapeutic experience: Attention deficit hyperactivity disorder (ADHD) Managed assigned investigational study sites, acting as a liaison between sponsor and investigator and performing on-site quality reviews of case report form data. Conducted monitoring visits to ensure compliance with protocol, FDA and ICH regulations, Good Clinical Practices, and relevant standard operating procedures. Therapeutic experience: Attention deficit hyperactivity disorder (ADHD)



LAWRENCE W. ADLER, M.D., P.A.

• United States
• Medical Practices

• Psychological Associate/Therapist

  • Jun 1997 - Jun 1998

  Conducted individual psychotherapy sessions, delivering personalized care to patients. Proficient in diagnosing a wide range of mental health conditions, including depression, panic disorder, obsessive-compulsive disorder, eating disorders, post-traumatic stress disorder, and alcohol abuse. Conducted individual psychotherapy sessions, delivering personalized care to patients. Proficient in diagnosing a wide range of mental health conditions, including depression, panic disorder, obsessive-compulsive disorder, eating disorders, post-traumatic stress disorder, and alcohol abuse.



Clinical Insights

• United States
• Hospitals and Health Care
• 1 - 100 Employee

• Certified Clinical Research Coordinator

  • Sep 1996 - Jun 1998

  Coordinated clinical research studies, including patient recruitment and screening, conducting psychological evaluations, and completing source documentation and case report forms. Monitored and negotiated grant reimbursements while communicating effectively with pharmaceutical representatives. Therapeutic experience: Major depressive disorder, bipolar disorder, obsessive compulsive disorder, Alzheimer’s disease, vascular dementia, geriatric psychosis, panic disorder, schizophrenia and migraine Show less



North Arundel Hospital

• United States
• Government Administration
• 1 - 100 Employee

• Research Assistant

  • Jun 1996 - Sep 1996

  Spearheaded patient recruitment and screening processes, ensuring a diverse and suitable participant pool for studies. Therapeutic experience: Obsessive compulsive disorder, Alzheimer’s disease, vascular dementia, geriatric psychosis, and migraine. Spearheaded patient recruitment and screening processes, ensuring a diverse and suitable participant pool for studies. Therapeutic experience: Obsessive compulsive disorder, Alzheimer’s disease, vascular dementia, geriatric psychosis, and migraine.