MapLight Therapeutics, Inc.

Director, Clinical Development

MapLight Therapeutics, Inc.

full-time

Posted on:

Location Type: Remote

Location: California • Massachusetts • United States

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Salary

💰 $275,000 - $313,000 per year

Job Level

Lead

About the role

  • Collaborate with colleagues on a matrix team to ensure the optimal planning, implementation, interpretation and reporting of clinical studies, including:
  • Contribute to the design of study synopses/protocols that will rigorously evaluate the efficacy and safety of compounds in development
  • Participate in vendor selection and study start-up processes and study-related plans
  • Monitor clinical studies, focusing on quality and adherence to Good Clinical Practice
  • Continually evaluate study data and study metrics, including eligibility criteria, trend analyses, outlier analyses, protocol compliance, deviations, and timelines
  • Partner with pharmacovigilance to review and report clinical safety data for presentation to key internal and external stakeholders, including management and Data Safety Boards
  • Interact with sites and CROs to support study awareness, patient recruitment, and quality of study conduct
  • Contribute to the preparation and review of regulatory documents, IND annual reports, IND safety reports, Investigator Brochures and development plans.
  • Participate in study start-up processes
  • Contribute to the writing of final study reports
  • Promote a high-performance culture and respectful work environment.
  • Comply with all applicable laws, regulations and regulatory guidelines as well as SOPs and ethical standards.
  • You can participate and work effectively with multiple cross-functional teams.
  • You have strong interpersonal skills and understand relationships are key to being successful.
  • You are a leader. Teams love working with you, and you are someone who takes pride in mentoring and supporting the careers of others.
  • You’re a team player who is willing to roll-up your sleeves and get the job done.

Requirements

  • MD (Medical Doctor or equivalent)
  • Board eligible/certified preferred
  • Active license preferred
  • Minimum 2 years industry experience in clinical research and medical monitoring.
  • Excellent clinical judgment with thorough understanding of medical and clinical research norms and practices
  • Methodical detail-oriented mindset with strong organizational abilities
  • Proficient with computerized systems and electronic databases
  • Demonstrated ability to work well within a geographically diverse team structure.
  • Strong communication and presentation skills.
  • Strong verbal and written command of the English language.
  • Highly motivated, self-driven and dependable.
  • Flexible availability, as needed for monitoring clinical trials.
  • Committed to MapLight's Core Beliefs and Values.
Benefits
  • annual bonus opportunity
  • medical, dental, vision, life and AD&D
  • short term and long term disability
  • 401(K) plan with match
  • stock options
  • flexible non-accrual paid time off
  • parental leave
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
clinical researchmedical monitoringstudy designdata analysisprotocol complianceregulatory document preparationsafety reportingtrend analysisoutlier analysisGood Clinical Practice
Soft Skills
interpersonal skillsleadershipmentoringorganizational abilitiescommunication skillsteam collaborationflexibilityself-motivationdependabilitydetail-oriented
Certifications
MDBoard certifiedActive medical license