Vice President, Clinical Development
La Jolla, CA
Full Time
Senior Executive
Job Title: Vice President, Clinical Development
Reporting To: CMO
Department: R&D Management
People Manager: Yes
FLSA Status: Exempt
Location: La Jolla, CA
Company Background
Longboard Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on developing novel, transformative medicines for neurological diseases. Longboard is working to advance a portfolio of centrally acting product candidates designed to be highly selective for specific G protein-coupled receptors (GPCRs). Longboard’s small molecule product candidates are based on more than 20 years of GPCR research. Longboard plans to advance bexicaserin (LP352), an oral, centrally acting 5-hydroxytryptamine 2C (5-HT2C) receptor superagonist, with no observed impact on 5-HT2B and 5-HT2A receptor subtypes, into a global Phase 3 program. In January 2024, Longboard reported topline data from a Phase 1b/2a clinical trial, the PACIFIC Study, evaluating bexicaserin in participants ages 12 to 65 years old with a broad range of Developmental and Epileptic Encephalopathies (DEEs), including Lennox-Gastaut syndrome, Dravet syndrome and other DEEs. “These exciting PACIFIC Study results underscore our belief that bexicaserin’s differentiated profile will translate into a clinically and commercially best-in-class product and has the potential to redefine the standard of care in DEEs. We are pleased to see such strong seizure reduction across a wide range of DEE syndromes with varying etiologies coupled with favorable safety and tolerability results,” stated Dr. Randall Kaye, Longboard’s Chief Medical Officer. “We would like to thank the entire DEE community, including study participants, their caregivers and advocacy groups, as well as the investigators, sites and coordinators for their participation and continued partnership as we advance into a Phase 3 program. This tremendous milestone brings us one step closer to improving the lives of those living with these devastating diseases and their families.”
Longboard is also evaluating LP659, an oral, centrally acting, sphingosine-1-phosphate (S1P) receptor subtypes 1 and 5 modulator, which is in development for the potential treatment of rare neuroinflammatory conditions. Longboard has initiated a Phase 1 single-ascending dose (SAD) clinical trial for LP659 in healthy volunteers, with topline data expected in the first half of 2024.
Position Summary
Reporting to the EVP/Chief Medical Officer, the Vice President, Clinical Development provides medical leadership for multiple small molecule programs. The Vice President is responsible for the development and execution of translational medicine and clinical development strategies including the design, implementation, monitoring, analysis, and reporting of clinical studies conducted within one or more programs. In addition, he/she/they collaborate with other team members and functions to develop long-range strategic plans for the programs and execute upon these plans.
Responsibilities include but may not be limited to:
• Lead and design translational medicine and clinical development strategies for one of more clinical programs.
• Lead activities related to phase 1-4 clinical trials (e.g., develop protocols, investigator brochures, and clinical study reports; review clinical trial documents, CRO management, clinical support of regulatory interaction, and study analysis and reporting).
• Partner with Biology and Biomarkers & Precision Medicine to development translational biomarker plans that are integrated into clinical trials
• Partner with Quality Assurance, Regulatory Affairs, and Project Management to ensure timely and effective clinical and scientific input into overall program.
• Lead investigator meetings and site initiation visits with clinical trial investigators, and partner with Clinical Operations in driving enrollment into the clinical studies
• Represent the company at scientific meetings, patient advocacy events and presentations, as well as other public relations opportunities, as directed by the CMO and Clinical Development
• Study Data Review and Analysis
• Provide clinical input into statistical planning and lead data analysis and interpretation
• Perform ongoing review and analysis of study data
• Provide medical leadership as needed for scientific issues that may arise during clinical trial execution
• Provide medical leadership and support for publication of data (e.g., manuscripts, posters) and disease or technology related scientific publications
• Build to scale a world class cross functional clinical development organization, upon the right inflection points and at a sensible cadence
• Define, plan and provide Medical Monitoring to clinical development studies
• Review adverse events, monitor safety, and prepare analysis and regulatory submission.
• Conduct thorough medical review of individual case safety reports (ICSRs)
Minimum Requirements
• Medical Degree required; experience in a relevant specialty such as Neurology, Pediatrics and/or Rare Diseases preferred.
• 7+ years biotechnology/pharmaceutical relevant experience leading clinical drug development (early-stage development through approval,) including developing clinical protocols, study design and successful regulatory approval (INDs, BLAs, NDAs) with US and international regulatory agencies
• Proven clinical development experience designing, implementing and conducting clinical trials
• A history of strong collaboration and personal interaction with all levels of internal stakeholders including, Regulatory Affairs, Clinical Operations, Research, and Product Development
• Understanding of global pharmacovigilance regulatory requirements and guidance documents and proven ability to influence decision making around multifaceted issues involving medical safety
• Outstanding leadership skills; comfortable working in a flexible, dynamically changing and challenging environment
• Excellent strategic planning, organizational and communication skills
• Highest level of scientific integrity
• Expertise and consistent success in scientific research and/or clinical practice, as evidenced by appropriate higher qualifications, publication and/or relevant specialist accreditation
• Strong computer skills including MS Office Suite (Word, Excel, PowerPoint, Outlook, MS Project) and in the use of industry-standard software (e.g., electronic data capture systems) and proficient in data analysis software and data presentation
• Willingness to travel ~25%, with international travel at times
Pay Transparency
The expected salary for candidates who work in La, Jolla, CA is $350-400k. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the industry, education, etc. Longboard Pharmaceuticals, Inc is a multi-state employer and will consider candidates based in remote work locations.
Benefits
At Longboard, we prioritize the well-being and satisfaction of our employees, understanding that benefits play a crucial role in their overall compensation and life quality. We take pride in providing a robust suite of benefits designed to safeguard the health and happiness of our team members, their families, and their lifestyles.
Our benefits currently include:
#LI-Hybrid
Reporting To: CMO
Department: R&D Management
People Manager: Yes
FLSA Status: Exempt
Location: La Jolla, CA
Company Background
Longboard Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on developing novel, transformative medicines for neurological diseases. Longboard is working to advance a portfolio of centrally acting product candidates designed to be highly selective for specific G protein-coupled receptors (GPCRs). Longboard’s small molecule product candidates are based on more than 20 years of GPCR research. Longboard plans to advance bexicaserin (LP352), an oral, centrally acting 5-hydroxytryptamine 2C (5-HT2C) receptor superagonist, with no observed impact on 5-HT2B and 5-HT2A receptor subtypes, into a global Phase 3 program. In January 2024, Longboard reported topline data from a Phase 1b/2a clinical trial, the PACIFIC Study, evaluating bexicaserin in participants ages 12 to 65 years old with a broad range of Developmental and Epileptic Encephalopathies (DEEs), including Lennox-Gastaut syndrome, Dravet syndrome and other DEEs. “These exciting PACIFIC Study results underscore our belief that bexicaserin’s differentiated profile will translate into a clinically and commercially best-in-class product and has the potential to redefine the standard of care in DEEs. We are pleased to see such strong seizure reduction across a wide range of DEE syndromes with varying etiologies coupled with favorable safety and tolerability results,” stated Dr. Randall Kaye, Longboard’s Chief Medical Officer. “We would like to thank the entire DEE community, including study participants, their caregivers and advocacy groups, as well as the investigators, sites and coordinators for their participation and continued partnership as we advance into a Phase 3 program. This tremendous milestone brings us one step closer to improving the lives of those living with these devastating diseases and their families.”
Longboard is also evaluating LP659, an oral, centrally acting, sphingosine-1-phosphate (S1P) receptor subtypes 1 and 5 modulator, which is in development for the potential treatment of rare neuroinflammatory conditions. Longboard has initiated a Phase 1 single-ascending dose (SAD) clinical trial for LP659 in healthy volunteers, with topline data expected in the first half of 2024.
Position Summary
Reporting to the EVP/Chief Medical Officer, the Vice President, Clinical Development provides medical leadership for multiple small molecule programs. The Vice President is responsible for the development and execution of translational medicine and clinical development strategies including the design, implementation, monitoring, analysis, and reporting of clinical studies conducted within one or more programs. In addition, he/she/they collaborate with other team members and functions to develop long-range strategic plans for the programs and execute upon these plans.
Responsibilities include but may not be limited to:
• Lead and design translational medicine and clinical development strategies for one of more clinical programs.
• Lead activities related to phase 1-4 clinical trials (e.g., develop protocols, investigator brochures, and clinical study reports; review clinical trial documents, CRO management, clinical support of regulatory interaction, and study analysis and reporting).
• Partner with Biology and Biomarkers & Precision Medicine to development translational biomarker plans that are integrated into clinical trials
• Partner with Quality Assurance, Regulatory Affairs, and Project Management to ensure timely and effective clinical and scientific input into overall program.
• Lead investigator meetings and site initiation visits with clinical trial investigators, and partner with Clinical Operations in driving enrollment into the clinical studies
• Represent the company at scientific meetings, patient advocacy events and presentations, as well as other public relations opportunities, as directed by the CMO and Clinical Development
• Study Data Review and Analysis
• Provide clinical input into statistical planning and lead data analysis and interpretation
• Perform ongoing review and analysis of study data
• Provide medical leadership as needed for scientific issues that may arise during clinical trial execution
• Provide medical leadership and support for publication of data (e.g., manuscripts, posters) and disease or technology related scientific publications
• Build to scale a world class cross functional clinical development organization, upon the right inflection points and at a sensible cadence
• Define, plan and provide Medical Monitoring to clinical development studies
• Review adverse events, monitor safety, and prepare analysis and regulatory submission.
• Conduct thorough medical review of individual case safety reports (ICSRs)
Minimum Requirements
• Medical Degree required; experience in a relevant specialty such as Neurology, Pediatrics and/or Rare Diseases preferred.
• 7+ years biotechnology/pharmaceutical relevant experience leading clinical drug development (early-stage development through approval,) including developing clinical protocols, study design and successful regulatory approval (INDs, BLAs, NDAs) with US and international regulatory agencies
• Proven clinical development experience designing, implementing and conducting clinical trials
• A history of strong collaboration and personal interaction with all levels of internal stakeholders including, Regulatory Affairs, Clinical Operations, Research, and Product Development
• Understanding of global pharmacovigilance regulatory requirements and guidance documents and proven ability to influence decision making around multifaceted issues involving medical safety
• Outstanding leadership skills; comfortable working in a flexible, dynamically changing and challenging environment
• Excellent strategic planning, organizational and communication skills
• Highest level of scientific integrity
• Expertise and consistent success in scientific research and/or clinical practice, as evidenced by appropriate higher qualifications, publication and/or relevant specialist accreditation
• Strong computer skills including MS Office Suite (Word, Excel, PowerPoint, Outlook, MS Project) and in the use of industry-standard software (e.g., electronic data capture systems) and proficient in data analysis software and data presentation
• Willingness to travel ~25%, with international travel at times
Pay Transparency
The expected salary for candidates who work in La, Jolla, CA is $350-400k. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the industry, education, etc. Longboard Pharmaceuticals, Inc is a multi-state employer and will consider candidates based in remote work locations.
Benefits
At Longboard, we prioritize the well-being and satisfaction of our employees, understanding that benefits play a crucial role in their overall compensation and life quality. We take pride in providing a robust suite of benefits designed to safeguard the health and happiness of our team members, their families, and their lifestyles.
Our benefits currently include:
- Hybrid work schedule out of our La Jolla office, 2-3 days a week
- Competitive compensation package including bonus opportunities and stock options
- Medical, Dental & Vision Plans
- 401(k) Plan, including company match with immediate vesting
- Flexible Time Off, including one week off in the summer and one week off around December holidays
- 11 paid company holidays per year
- An opportunity to do truly meaningful work to make a lasting impact
- Longboard Perks (on-site gym, garage parking, company-sponsored events, etc.)
- Flexible spending account for medical care
- Life insurance, short and long term disability plans
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