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    Vice President, Clinical Development - San Diego, United States - Longboard Pharmaceuticals

    Longboard Pharmaceuticals
    Longboard Pharmaceuticals San Diego, United States

    3 weeks ago

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    Description

    Job Title:
    Vice President, Clinical Development


    Reporting To:

    CMO

    Department :
    R&D Management


    People Manage r:
    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
    CMOand 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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